Search

PURPOSE Limited tools exist to predict the risk of chemotherapy toxicity in older adults with early-stage breast cancer. METHODS Patients of age ≥ 65 years with stage I-III breast cancer from 16 institutions treated with neoadjuvant or adjuvant chemotherapy were prospectively evaluated for geriatric and clinical features predictive of grade 3-5 chemotherapy toxicity. Logistic regression with best-subsets selection was used to identify and incorporate independent predictors of toxicity into a model with weighted variable scoring. Model performance was evaluated using area under the ROC curve (AUC) and goodness-of-fit statistics. The model was internally and externally validated. RESULTS In 473 patients (283 in development and 190 in validation cohort), 46% developed grade 3-5 chemotherapy toxicities. Eight independent predictors were identified (each assigned weighted points): anthracycline use (1 point), stage II or III (3 points), planned treatment duration > 3 months (4 points), abnormal liver function (3 points), low hemoglobin (3 points), falls (4 points), limited walking (3 points), and lack of social support (3 points). We calculated risk scores for each patient and defined three risk groups: low (0-5 points), intermediate (6-11 points), or high (≥ 12 points). In the development cohort, the rates of grade 3-5 chemotherapy toxicity for these three groups were 19%, 54%, and 87%, respectively ( P < .01). In the validation cohort, the corresponding toxicity rates were 27%, 45%, and 76%. The AUC was 0.75 (95% CI, 0.70 to 0.81) in the development cohort and 0.69 (95% CI, 0.62 to 0.77) in the validation cohort. Risk groups were also associated with hospitalizations and reduced dose intensity ( P < .01). CONCLUSION The Cancer and Aging Research Group-Breast Cancer (CARG-BC) score was developed and validated to predict grade 3-5 chemotherapy toxicity in older adults with early-stage breast cancer.

PURPOSE: Geriatric assessment (GA) results predict toxicity/survival in older adults, yet GA is not routinely used in care for patients with multiple myeloma (MM). We tested a tablet-based modified GA (mGA) providing real-time results to clinicians. METHODS: One hundred sixty-five patients with MM aged ≥ 65 years facing a treatment decision from 4 sites completed a tablet-based mGA with Katz Activities of Daily Living (ADL), Lawton Instrumental ADL, Charlson Comorbidity Index, and variables from the Cancer and Aging Research Group’s Chemotherapy Toxicity Calculator. Providers reviewed the assessment results at the treatment visit. RESULTS: Patients were white (72%; n = 86), mean age was 72 years (range, 65-85 years), and averaged 7.71 minutes (range, 2-17 minutes) for survey completion. Providers averaged 3.2 minutes (range, 1-10 minutes) to review mGA results. Using International Myeloma Working Group frailty score, patients were fit (39%; n = 64), intermediate fit (33%; n = 55), or frail (28%; n = 46). Providers selected more aggressive treatments in 16.3% of patients and decreased treatment intensity in 34% of patients; treatment intensification was more common for fit patients and milder treatments for frail patients (χ2 = 20.02; P < .0001). Transplant eligibility significantly correlated with fit status and transplant ineligibility with frail status ( P = .004). Outcomes on 144 patients 3 months post study visit showed 19.4% (n = 28) had grade ≥ 3 hematologic toxicities, 38.9% (n = 56) had dose modifications, and 18% (n = 26) had early therapy cessation. CONCLUSION: Limited patient time required for survey completion and provider time for results review show mGA can be easily incorporated into clinical workflow. Real-time mGA results indicating fit/frailty status influenced treatment decisions.

Purpose Some research has suggested that discussion of prognosis can disrupt the patient-physician relationship. This study assessed whether physician discussion of prognosis is associated with detrimental changes in measures of the strength of the patient-physician relationship. Methods This was a longitudinal cohort study of 265 adult patients with advanced cancer who visited 38 oncologists within community- and hospital-based cancer clinics in Western New York and Northern California. Prognostic discussion was assessed by coding transcribed audio-recorded visits using the Prognostic and Treatment Choices (PTCC) scale and by patient survey at 3 months after the clinic visit. Changes in the strength of the patient-physician relationship were computed as differences in patient responses to The Human Connection and the Perceived Efficacy in Patient-Physician Interactions scales from baseline to 2 to 7 days and 3 months after the clinic visit. Results Prognostic discussion was not associated with a temporal decline in either measure. Indeed, a one-unit increase in PTCC during the audio-recorded visit was associated with improvement in The Human Connection scale at 2 to 7 days after the visit (parameter estimate, 0.10; 95% CI, −0.02 to 0.23) and 3 months after the visit (parameter estimate, 0.18; 95% CI, 0.02 to 0.35) relative to baseline. Standardized effect sizes (SES) associated with an increase of two standard deviations in the PTCC at each time point were consistent with small beneficial effects (SES, 0.14 [95% CI, −0.02 to 0.29] at 2 to 7 days; SES, 0.24 [95% CI, 0.02 to 0.45] at 3 months), and lower bounds of CIs indicated that substantial detrimental effects of prognostic discussion were unlikely. Conclusion Prognostic discussion is not intrinsically harmful to the patient-physician relationship and may even strengthen the therapeutic alliance between patients and oncologists.

Purpose Cancer-related cognitive impairment is an important problem for patients with breast cancer, yet its trajectory is not fully understood. Some previous cancer-related cognitive impairment research is limited by heterogeneous populations, small samples, lack of prechemotherapy and longitudinal assessments, use of normative data, and lack of generalizability. We addressed these limitations in a large prospective, longitudinal, nationwide study. Patients and Methods Patients with breast cancer from community oncology clinics and age-matched noncancer controls completed the Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) at prechemotherapy and postchemotherapy and at a 6-month follow-up as an a priori exploratory aim. Longitudinal models compared FACT-Cog scores between patients and controls at the three assessments and adjusted for age, education, race, menopausal status, and baseline reading ability, anxiety, and depressive symptoms. A minimal clinically important difference cutoff determined percentages of impairment over time. Results Of patients, 581 patients with breast cancer (mean age, 53 years; 48% anthracycline-based regimens) and 364 controls (mean age, 53 years) were assessed. Patients reported significantly greater cognitive difficulties on the FACT-Cog total score and four subscales from prechemotherapy to postchemotherapy compared with controls as well as from prechemotherapy to 6-month follow-up (all P < .001). Increased baseline anxiety, depression, and decreased cognitive reserve were significantly associated with lower FACT-Cog total scores. Treatment regimen, hormone, or radiation therapy was not significantly associated with FACT-Cog total scores in patients from postchemotherapy to 6-month follow-up. Patients were more likely to report a clinically significant decline in self-reported cognitive function than were controls from prechemotherapy to postchemotherapy (45.2% v 10.4%) and from prechemotherapy to 6-month follow-up (36.5% v 13.6%). Conclusion Patients with breast cancer who were treated in community oncology clinics report substantially more cognitive difficulties up to 6 months after treatment with chemotherapy than do age-matched noncancer controls.

12037 Background: Poor prognostic understanding of curability is associated with lower hospice use in patients with advanced cancer. Little is known if this holds true for older adults specifically. In addition, prognostic understanding are variably assessed and defined in prior studies. We evaluated the associations of poor prognostic understanding and patient-oncologist discordance in both curability and survival estimates with hospitalization and hospice use in older patients with advanced cancer. Methods: We utilized data from a national geriatric assessment cluster-randomized trial (URCC 13070: PI Mohile) that recruited 541 patients aged ≥70 with incurable solid tumor or lymphoma considering any line of cancer treatment and their oncologists. At enrollment, patients and oncologists were asked about their beliefs about cancer curability (options: 100%, > 50%, 50/50, < 50%, 0%, and uncertain) and estimates of patient’s survival (options: 0-6 months, 7-12 months, 1-2 years, 2-5 years, and > 5 years). Non-0% options were considered poor understanding of curability (uncertain was removed from the analysis) and > 5 years was considered poor understanding of survival estimates. Any difference in response options was considered discordant. We used generalized estimating equations to estimate adjusted odds ratios (AOR) assessing associations of poor prognostic understanding and discordance with hospitalization and hospice use at 6 months, adjusting for covariates and practice clusters. Results: Poor prognostic understanding of curability and survival estimates occurred in 59% (206/348) and 41% (205/496) of patients, respectively. Approximately 60% (202/336) and 72% (356/492) of patient-oncologist dyads were discordant in curability and survival estimates, respectively. In the first 6 months after enrollment, 24% were hospitalized and 15% utilized hospice. Poor prognostic understanding of survival estimates was associated with lower odds of hospice use (AOR 0.30, 95% CI 0.16-0.59) (Table). Discordance in survival estimates was associated with greater odds of hospitalization (AOR 1.64, 95% CI 1.01-2.66). Conclusions: Prognostic understanding may be associated with hospitalization or hospice use depending on how patients were queried about their prognosis and whether oncologists’ estimates were considered.[Table: see text]

12010 Background: Despite high prevalence of functional status (FS) and physical performance (PP) impairments among older adults with cancer, standardized assessments and interventions are not routinely used in oncology care. This study characterized how oncologist knowledge of Geriatric Assessment (GA) results influenced conversations and GA-guided recommendations addressing FS and PP concerns. Methods: Data were from a NCORP funded (UG1CA189961) nationwide cluster randomized controlled trial (ClinicalTrials.gov: NCT02107443; PI: Mohile), with inclusion criteria: age ≥70, stage III/IV solid tumor or lymphoma with palliative treatment intent, and ≥1 GA domain impairment. All subjects underwent baseline GA including standardized FS ([instrumental] activities of daily living) and PP (Timed Up and Go, Short Physical Performance Battery, Older Americans Resources and Services Physical Health scale, falls in past 6 months) measures. Oncologists in Intervention arm practices received full GA results and validated recommendations for each patient, while those in the usual care (UC) arm were only notified of depression or severe cognitive impairment. One clinical encounter per patient within 4 weeks of GA was audio-recorded, transcribed and blind coded using a priori content-analysis scheme to categorize conversations and oncologist response (dismissed, acknowledged, or addressed with recommendation) by GA domain. Frequencies, raw and adjusted (for site using generalized linear mixed models) proportions were compared using the Chi square test. Results: 541 patients (mean age: 77, range 70-96) were included. More FS and PP conversations occurred in Intervention (PP=532, FS=164) than UC (PP=183, FS=87) arm (p

6585 Background: Functional impairments affect > 40% of hospitalized patients (pts) with advanced cancer. After hospital discharge, about 20% of pts received rehabilitation (rehab) in nursing homes (NHs) to maintain functional independence. There is evidence from broad pt cohorts that Medicare Prospective Payment (PP) financially incentivizes NHs to provide extra rehab. This study examines rehab utilization among pts with advanced cancer admitted to NHs. Methods: The 2011-2016 SEER-Medicare data were linked with NH Minimum Data Set 3.0 data, which includes sociodemographic and clinical characteristics at admission. Study cohort included traditional Medicare pts with stage IV breast, lung, and colorectal cancer who were admitted to NHs after hospital discharge. Outcomes: total weekly rehab minutes of physical therapy, occupational therapy, and speech-language pathology; ultra-high rehab (≥720 min/wk); and rehab within 10 minutes of threshold (720-730 min/wk). Function and cognition were assessed by Activities of Daily Living (ADL) [7 domains; total score ranges 0 to 28 (higher = dependent)] and Cognitive Function Scale (intact, mild, moderate, severe impairment). Charlson Comorbidity Index (CCI) and survival from NH admission were computed. Generalized linear mixed models examined predictors of rehab outcomes adjusting for NH random effects. Results: A total of 7,453 pts were included (mean age 78.0, 85.8% White, 74.1% lung/ 16.1% colorectal/ 9.7% breast cancer; 76.1% had surgery, 8.9% had chemotherapy; mean CCI 1.9). The mean ADL score was 18.0, with on average 4.7 impairments; 40.2% reported ≥ mild cognitive impairment. Pts received on average 498 (SD = 245) min/wk rehab, but the distribution was trimodal. The number of pts who received 720-730 min/wk rehab was 2.7 times of the secondary peak at 500-510. From 2011-2016, the proportion of pts receiving ultra-high therapy (19.5%-48.4%) and within-threshold rehab (11.0%-32.0%) more than doubled. Only 5.9% of pts were documented on admission as having a life expectancy < 6 months, yet 32.1% and 74.3% died in 30 days and 6 months, respectively. Multivariable regressions indicate that compared to pts with ≥6 months’ expectancy, those with < 6 months’ expectancy received less rehab (β = -117.6), especially ultra-high rehab (odds ratio = 0.31). Pts with cognitive impairments received less rehab. Conclusions: Rehab utilization in older NH pts with advanced cancer mirrors patterns found in broader cohorts. Under PP, rehab minutes provided strongly followed payment thresholds. Over 5 years, more pts were provided 720-730 min/wk rehab, and 1/3 of these pts were at the end of life. Poor prognostication might contribute to the use of ultra-high rehab. Future work should evaluate whether the new Patient Driven Payment Model avoids excessive rehab use in patients with limited life expectancies.

12049 Background: Prior studies suggest that social support plays a role in disease understanding of older patients with advanced cancer. In this study, we examined the association of quantity and quality of social support with belief in curability among older patients with advanced incurable cancer. Methods: We performed a secondary analysis of a cluster-randomized geriatric assessment trial (URCC 13070: PI Mohile) that recruited older adults (≥70) with advanced incurable cancer and caregivers. At enrollment, patients completed the Older Americans Resources and Services (OARS) Medical Social Support form to measure both quantity (number of close friends and relatives) and quality of social support. Quality of social support was measured using twelve questions, each ranged from 1 (none of the time) to 5 (all of the time). Higher cumulative scores indicated greater quality of support. For beliefs in curability, patients were asked, “What do you believe are the chances that your cancer will go away and never come back with treatment?” Responses were 0%, 50%, and 100%. Ordinal logistic regression was used to investigate the association of social support with beliefs in curability, adjusting for adjusting for age, gender, education, race, number of Geriatric Assessment (GA) impairments, cancer type, and locality (rural versus urban). Results: We included 347 patients; mean age was 76.4 years, 91% were white, 52% were male, 46% had household income

12016 Background: CRCI is a debilitating consequence of cancer and its treatment, including difficulties in attention, memory, and executive function. Though CRCI can develop during the course of chemotherapy, interventions targeting CRCI during chemotherapy have not been investigated. Inflammation contributes to CRCI and thus reducing inflammation may ameliorate CRCI. Using a biobehavioral approach, we investigated 2 promising interventions that reduce inflammation: exercise and low-dose ibuprofen. Methods: This is a Phase II RCT with a 2:2 factorial design. Eligible participants were patients with cancer receiving chemotherapy who self-reported cognitive difficulties. Participants were stratified by disease type (breast cancer; gastrointestinal cancer; other) and were randomized to 1 of 4 groups for 6 weeks: exercise alone (+ placebo), ibuprofen alone, exercise + ibuprofen, or placebo only. The exercise intervention, delivered by an exercise physiologist, was Exercise for Cancer Patients (EXCAP), an individually tailored, home-based prescription of walking and resistance band training. Ibuprofen/placebo was over-encapsulated for blinding; 200mg was taken 2 times per day. Participants completed 7 cognitive assessments probing attention, memory, and executive function including the Trail Making Test (TMT) and self-report (FACT-Cog) at baseline and post-intervention. ANCOVA, controlling for baseline, assessed overall Arm effects at post-intervention. Results: Of the 110 who consented to the study, 86 participants (mean age=54; 88% female; 76% breast cancer, 21% GI; 73% Stage I-III) completed baseline assessments and were randomized to one of four study arms. Ninety percent (78/86) of those completed post-intervention. Average pill compliance across all 4 groups was balanced and averaged 90.8%. Participants in the exercise and exercise + ibuprofen arms increased 2,414 and 1,073 steps respectively compared to those in placebo and ibuprofen arms increased only 464 and 412 steps respectively from pre- to post-intervention. No study-related adverse events occurred. Intent to treat ANCOVA analyses revealed a significant improvement in attention (TMT) in exercise alone compared to placebo (21.57 seconds better; p=0.003), ibuprofen alone compared to placebo (11.27 seconds better; p=0.0475), and trend for exercise + ibuprofen (7.98 seconds better; p=0.122). Those participating in both exercise arms exhibited significant improvements in the FACT-Cog Comments from Others subdomain (p

e24013 Background: Despite the growing burden of cancer in older adults in Mexico, it is unknown how many cancer care providers in Mexico use information obtained through a geriatric assessment (GA) and/or geriatric oncology principles in their everyday clinical practice. Methods: We administered a cross-sectional survey to oncology providers in Mexico via the Mexican Society of Oncology mailing list (n = 1240). The survey included questions on demographics, awareness about geriatric oncology principles, and the use of the GA and other geriatric clinical tools. The primary outcome was to estimate the proportion of providers using GA tools through the question: “For your patients ≥65 years, do you perform a multidimensional geriatric assessment using validated tools?”. We hypothesized that ≤10% of respondents would give a positive answer. We used descriptive statistics and X2 tests to compare groups of respondents. Results: We obtained 196 answers (response rate 15.8%). 121 (62%) respondents were male; median age 42. 98 (50%) were surgical oncologists, 59 (30%) medical oncologists, and 38 (19%) radiation oncologists. Median time in practice was 8 years, with 39% practicing in Mexico City. A third had their practice at a public institution, 26% at a private institution, and 38% in both. The proportion of patients aged 65-79 and ≥80 seen on an average clinic day by the respondents was 30% and 10%, respectively. 121 (62%) reported having a geriatrician available at their practice site. 37 respondents (19%) reported using validated GA tools to evaluate older adults with cancer in their practice. The proportion of respondents who evaluated each GA domain is shown in Table 1. Male respondents (p=0.03), medical oncologists (p

562 Background: Chemotherapy adversely affects the immune system and physical function. Inflammation is independently associated with functional decline. Compared to the individual cytokines [e.g., interleukin-6 (IL-6)], the pro-inflammatory index, IL-6/IL-10 ratio, is a better predictor of poor outcomes and mortality in many diseases. Other markers of inflammation such as soluble tumor necrosis factor (sTNFR) I, and sTNFRII have also been shown to be predictive of poor outcomes. We have previously reported a significant increase in sTNFRI/II with chemotherapy in patients with breast cancer. However, it is not yet understood if chemotherapy-related changes to inflammatory makers is associated with physical function after treatment. In this study, we assessed the relationship between changes of pro-inflammatory markers during chemotherapy with physical function after completing chemotherapy. Methods: This was a secondary analysis of a large nationwide cohort study in women with stage I-III breast cancer (NCT01382082). Serum levels of IL6, IL10, sTNFRI, and sTNFRII were measured ≤7 days before chemotherapy (T1) and ≤1 month after chemotherapy (T2), and the IL6/IL10 ratio was calculated. Absolute changes (T2-T1) of sTNFR-I and sTNFRII (reported in pg/mL) and the IL6/IL10 ratio were calculated. Physical function was measured by the Functional Assessment of Cancer Therapy: General – physical well being (FACT-PWB) at T1 and T2 and contains 7-items, each using a 5-point rating scale ranging from 0 (Not at all) to 4 (Very much), with a total score ranging from 0-28; higher scores represent higher physical function. ANOVA was used to compare means of FACT-PWD scores and mean changes of pro-inflammatory markers. Multivariate linear regressions were used to determine if increased pro-inflammatory markers were associated with lower FACT-PWD at T2, controlling for baseline FACT-PWD, age, race, education, and marital status. Results: We included 580 patients (mean age=53 years, range 22-81). Physical function significantly and clinically declined from T1-T2 (mean=22.2, SE=0.23 vs mean=19.4, SE=0.25; p

Since the beginning of its guidelines program in 1993, ASCO has continually sought ways to produce a greater number of guidelines while maintaining its commitment to using the rigorous development methods that minimize the biases that threaten the validity of practice recommendations. ASCO is implementing a range of guideline development and implementation innovations. In this article, we describe innovations that are designed to (1) integrate consideration of multiple chronic conditions into practice guidelines; (2) keep more of its guidelines current by applying evolving signals or (more) rapid, for-cause updating approaches; (3) increase the number of high-quality guidelines available to its membership through endorsement and adaptation of other groups’ products; (4) improve coverage of its members’ guideline needs through a new topic nomination process; and (5) enhance dissemination and promote implementation of ASCO guidelines in the oncology practice community through a network of volunteer ambassadors. We close with a summary of ASCO’s plans to facilitate the integration of data from its rapid learning system, CancerLinQ, into ASCO guidelines and to develop tactics through which guideline recommendations can be embedded in clinicians’ workflow in digital form. We highlight the challenges inherent in reconciling the need to provide clinicians with more interactive, point-of-care guidance with ASCO’s abiding commitment to methodologic rigor in guideline development.

Purpose To provide evidence-based recommendations to oncologists and others on potentially curative therapy for patients with localized pancreatic cancer. Methods ASCO convened a panel of medical oncology, radiation oncology, surgical oncology, palliative care, and advocacy experts and conducted a systematic review of literature from January 2002 to June 2015. Outcomes included overall survival, disease-free survival, progression-free survival, and adverse events. Results Nine randomized controlled trials met the systematic review criteria. Recommendations A multiphase computed tomography scan of the abdomen and pelvis or magnetic resonance imaging should be performed for all patients to assess the anatomic relationships of the primary tumor and for the presence of intra-abdominal metastases. Baseline performance status, comorbidity profile, and goals of care should be evaluated and established. Primary surgical resection is recommended for all patients who have no metastases, appropriate performance and comorbidity profiles, and no radiographic interface between primary tumor and mesenteric vasculature. Preoperative therapy is recommended for patients who meet specific characteristics. All patients with resected pancreatic cancer who did not receive preoperative therapy should be offered 6 months of adjuvant chemotherapy in the absence of contraindications. Adjuvant chemoradiation may be offered to patients who did not receive preoperative therapy with microscopically positive margins (R1) after resection and/or who had node-positive disease after completion of 4 to 6 months of systemic adjuvant chemotherapy. Patients should have a full assessment of symptoms, psychological status, and social supports and should receive palliative care early. Patients who have completed treatment and have no evidence of disease should be monitored. Additional information is available at www.asco.org/guidelines/PCPC and www.asco.org/guidelineswiki .

138 Background: GA evaluates aging-related domains (e.g., function) known to be associated with cancer treatment toxicity. We found that providing a GA summary with management recommendations to oncologists reduces clinician-rated toxicity in older patients with advanced cancer receiving high risk treatment (presented at ASCO2020). Herein, we report on the effects of the GA intervention on symptomatic toxicities measured by Patient-Reported Outcomes Common Terminology Criteria for Adverse Events [PRO-CTCAE]. Methods: In the national cluster randomized clinical trial eligible patients (n=718) had age>70, advanced solid tumors or lymphoma, 1+ GA impairment, and were initiating a new treatment regimen with high risk of toxicity. Severity grade of 24 PRO-CTCAE items was collected on a 0-4 scale at enrollment, 4-6 weeks, 3, and 6 months. Of 24 items, 11 (e.g. fatigue, dyspnea) were classified as core (Reeve 2014). Baseline adjusted method (Basch 2016) was used to determine symptomatic toxicities: if the severity of any item increased after baseline to grade 2 or higher, the patient was classified as experiencing grade ≥2 event (similarly for grade ≥ 3 events). The effects of GA intervention on symptomatic toxicities were assessed using generalized linear mixed model (GLMM) with random effect for the practice cluster. Results: Mean age was 77 years (range 70-96); 43% female, 87% white; 34% had gastrointestinal and 25% had lung cancer; 27% received prior chemotherapy. 710 patients provided PRO-CTCAE data (366 usual care, 344 intervention), 85.6% reported grade ≥2 and 49.4% grade ≥3 events at baseline. After baseline, compared to usual care, patients in the GA intervention arm reported fewer grade ≥2 overall symptomatic toxicities (76.5% vs. 84.7%) and fewer core symptomatic toxicities (grade ≥2: 71.8% vs. 82.0%; grade ≥3: 46.2% vs. 53.6%). Specifically, less dyspnea and less fatigue was reported in GA-arm (Table). Conclusions: GA intervention resulted in fewer symptomatic toxicities as evaluated by PRO-CTCAE. Clinical trial information: NCT02054741 . [Table: see text]

33 Background: GA evaluates aging-related domains (e.g., function) known to be associated with cancer treatment toxicity. We found that providing a GA summary with management recommendations to oncologists reduces clinician-rated toxicity in older patients (pts) with advanced cancer receiving high risk treatment (presented @ASCO2020). Herein, we report secondary outcomes on the effects of the GA intervention on aging-related outcomes. Methods: Pts aged ≥ 70 with incurable solid tumors or lymphoma and ≥ 1 impaired GA domain starting a new treatment regimen were enrolled. Community oncology practices were randomized to intervention (oncologists received GA summary/recommendations) or usual care (none given). Secondary analyses examined effects of the intervention on functional outcomes (patient-reported falls, instrumental activities of daily living (IADL), short physical performance battery (SPPB), geriatric depression scale (GDS), and medications [total and prescription]). Outcomes were analyzed using linear mixed effects model, logistic or Poisson regression adjusted for baseline values, time, and site effects as appropriate. Results: From 2013-19, 718 pts were enrolled from 41 practices. Age (mean 77 yrs), sex (43% women), number of impaired GA domains (median 4/8), and treatment type (chemotherapy 88%) were not different by arm. More pts in intervention were black (12% vs 3%, p

143 Background: Caregivers of older adults with advanced cancer often have a different understanding of the patient’s prognosis compared with their oncologist. Among patients, accurate prognostic awareness is associated with greater depressive symptoms, except when patients utilize more adaptive coping skills. We examined the relationship between caregiver-oncologist prognostic concordance and caregiver depressive symptoms and explored whether this relationship differed by caregiver mastery, the capacity to cope, adjust, and adapt to problems. Methods: We utilized data from a national geriatric assessment cluster-randomized trial (URCC 13070: PI Mohile) that recruited patients aged ≥70 with incurable cancer considering any line of cancer treatment at community oncology practices, their caregivers, and oncologists. At enrollment, caregivers and oncologists estimated the patient’s prognosis (0-6 months, 7-12 months, 1-2 years, 2-5 years, > 5 years); same response was considered concordant. Caregivers completed Ryff’s mastery subscale (range 7-35, higher is better) at enrollment and depression screen (the Patient Health Questionnaire (PHQ)-2 (range 0-6) 4-6 weeks later. To assess the association of prognostic concordance with caregiver depressive symptoms, we used generalized estimating equations in models adjusted for cancer type, study arm, practice sites, and caregiver demographics. We then assessed moderation effect of caregiver mastery on this association. Results: Among 410 caregiver-oncologist dyads, mean caregiver age was 66.5, 75% were female, and 26% were caregivers of patients with lung cancer. Mean mastery score at enrollment was 27.6 (SD 4.7) and 19% screened positive on PHQ-2 at week 4-6. Among dyads who provided response (N = 370), 28% were concordant. Prognostic concordance was associated with higher caregiver depressive symptoms (β = 0.30; p = 0.04). Significant moderation effect was found between concordance and mastery for caregiver depressive symptoms (p = 0.02). Among caregivers with low mastery ( < median), prognostic concordance was associated with higher depressive symptoms (β = 0.68; p = 0.003). Among caregivers with high mastery (≥median), concordance was not associated with depressive symptoms (β = -0.06; p = 0.67). Conclusions: There is a need to study how prognostic understanding might lead to depression in at-risk caregivers. Interventions targeting caregiver prognostic understanding need to consider its relationship with depressive symptoms, while seeking to increase caregiver mastery.

12040 Background: Older patients with advanced cancer often have comorbidities that increase the risk of toxicity from neoplastic therapy but are not always considered in treatment planning. We assessed the utility of a geriatric assessment (GA) intervention to increase the number and quality of discussions about comorbidities among oncologists, older patients, and caregivers. Methods: This multi-site trial enrolled patients who were ≥70 years, had advanced solid tumors or lymphoma, had ≥1 GA impairment, and who were considering or receiving cancer treatment. All patients received the GA and completed an Older Americans Resources and Services Comorbidity survey, which evaluated 15 conditions and interference with activities (clinical impairment = ≥3 comorbidities or ≥1 highly interfering). Oncology practices were randomized to intervention (GA with a summary with management recommendations provided to oncologists) or usual care (GA only). The clinic visit after GA was audio-recorded, transcribed, and coded for GA topics including comorbidity. Generalized linear mixed models adjusting for site (random effect) were used to assess the effect of the intervention. Results: Patients (n=527 evaluable, 76.6±5.2 years, 49% female) and oncologists (n=131, 63 in intervention) were enrolled from 31 sites. In total, 94.5% of patients had ≥1 comorbidity with an average of 3.2±1.9; 64% were clinically impaired by comorbidity (p=0.76 between arms). The intervention arm had twice the number of conversations about comorbidities (1.02 vs. 0.52 conversations per patient, difference 0.50, 95% CI 0.18-0.81, p=0.004) and conversations were more likely to be initiated by the oncologist (p

549 Background: Chemotherapy adversely affects physical function. While many patients recover after treatment (i.e. are resilient), some are unable to return to their pre-treatment function (i.e. are non-resilient). Since immune dysfunction may play a role in functional decline, we assessed the relationship of pre-chemotherapy immune cell profiles with functional decline and resilience in women with breast cancer receiving chemotherapy. Methods: This study was based on a large nationwide cohort study in women with stage I-III breast cancer. Physical function was measured by the Functional Assessment of Cancer Therapy: General – Physical subscale (FACT-PWB) ≤7 days before chemotherapy (T1), ≤1 month after chemotherapy (T2), and 6 months after T2 (T3). Functional decline at T2 and T3 was defined as > 1 point decrease (clinically meaningful difference) in FACT-PWD score from T1. Patients were considered non-resilient if they had T2 functional decline and did not return to within 1 point of their baseline FACT-PWB score by T3. Immune cell counts, neutrophil:lymphocyte ratio (NLR), and lymphocyte:monocyte ratio (LMR) were obtained at T1. Multivariate logistic regressions were used to determine whether immune cell counts and ratios were associated with functional decline and being non-resilient controlling for baseline FACT-PWD, age, race, education, and marital status. Results: One-third of patients (178/529; mean age 53, range 22-81) had functional decline from T1-T3. Of the 59% (n = 310) of patients with functional decline at T2, 50% (n = 147) did not recover by T3 (i.e. were non-resilient). Patients with a low ( < median) NLR at T1 were twice as likely to have functional decline by T3 than those with a high (≥ median) NLR [Adjusted Odds Ratio (AOR) 1.8, 95% CI: 1.2-2.8, p < 0.01]. Similarly, in patients with functional decline at T2, those with a low NLR at T1 were twice as likely to be non-resilient than those with high NLR (AOR: 1.9, 95% CI: 1.1-3.2, p = 0.01). Conversely, patients with high T1 lymphocytes were twice as likely to be non-resilient than those with low lymphocytes (AOR: 1.8, 95% CI: 1.1-3.1, p = 0.02). Conclusions: One-third of women with breast cancer have clinically meaningful, persistent functional decline six months after completing chemotherapy. Higher pre-chemotherapy lymphocytes and lower NLR may be useful to identify which women are at increased risk of functional decline and reduced ability to regain baseline physical function. These findings can inform interventions to ameliorate this decline.

12009 Background: GA evaluates aging-related domains (e.g., function) known to be associated with cancer treatment toxicity. In this CRCT, we evaluated if providing a GA summary with management recommendations to oncologists can reduce toxicity in older patients (pts) with advanced cancer receiving chemotherapy and/or other agents with a high reported prevalence of grade 3-5 toxicity. Methods: Pts aged > 70 with incurable solid tumors or lymphoma and > 1 impaired GA domain starting a new treatment regimen were enrolled. Community oncology practices were randomized to intervention (oncologists received GA summary/recommendations for impairments) or usual care (none given). The primary outcome was proportion of pts who experienced any grade 3-5 toxicity (CTCAE v.4) within 3 months. Practice staff prospectively captured toxicities; blinded oncology clinicians reviewed medical records to verify. Secondary outcomes included 6 month overall survival (OS) and treatment intensity (standard vs reduced). Outcomes were analyzed using generalized linear mixed/Cox models with Arm as a fixed effect, controlling for practice. Results: From 2013-19, 718 pts were enrolled from 41 practices. Age (mean 77 yrs), sex (43% women), number of impaired GA domains (median 4/8), and treatment type (chemotherapy 88%) were not different by Arm. More pts in intervention were Black (12% vs 3%, p

12005 Background: Insomnia, a prevalent and troublesome side effect experienced by cancer survivors, significantly impairs recovery and survival. We conducted a nationwide, multicenter, phase III, blinded, randomized controlled trial testing whether 1) yoga is superior to survivorship health education (SHE) and 2) yoga is non-inferior to cognitive behavioral therapy for insomnia (CBT-I) for treating insomnia in survivors. Methods: The trial was conducted via the University of Rochester Cancer Center NCI Community Oncology Research Program (URCC NCORP) Research Base. Participants were cancer survivors between 2-60 months post adjuvant therapy, with insomnia, no metastatic disease, and no yoga participation during the previous 3 months. Survivors were randomized into 1) YOCAS yoga (2x/wk; 75 min/sess for 4 wks with pranayama, asana, and dhyana, N = 251), 2) CBT-I (1x/wk, 90 min/sess for 8 wks with sleep hygiene, stimulus control, sleep restriction, and cognitive therapy, N = 238), or 3) SHE (2x/wk; 75 min/sess for 4 wks with ASCO-recommended survivorship education, N = 251). Insomnia was assessed pre- and post-intervention via the Insomnia Severity Index. Results: 740 eligible cancer survivors were enrolled (93% female, mean age = 56 + 11, 75% breast cancer). ANCOVAs with baseline values as covariates revealed YOCAS is significantly better than SHE for treating insomnia at post-intervention (CS = change score; CS mean diff = -1.43, SE = 0.42, p < 0.01). Yoga participants demonstrated greater improvements in insomnia from pre- to post-intervention (CS = -3.61, SE = 0.30) compared to SHE participants (CS = -2.19, SE = 0.33, all p < 0.01). Intent-to-treat analyses of non-inferiority (non-inferiority margin set at 1.15 a priori) showed YOCAS is inferior to CBT-I (CS mean diff = 3.52, CI = 2.55 - 4.50, p < 0.01). However, analyses of non-inferiority using the optimal treatment effect in fully compliant survivors were inconclusive regarding whether YOCAS is non-inferior to CBT-I for treating insomnia (CS mean diff = 2.20, CI = 0.42 - 3.98, p = 0.09). Significantly more survivors withdrew from CBT-I and SHE due, in part, to disliking the interventions compared to YOCAS (30%, 25%, and 16%, respectively, p < 0.01). Conclusions: YOCAS yoga is better than SHE and results are inconclusive as to whether yoga is non-inferior to CBT-I for treating insomnia among survivors. Clinicians should consider prescribing YOCAS and CBT-I for survivors reporting insomnia. Funding: NCI UG1CA189961, R01CA181064, T32CA102618. Clinical trial information: NCT02613364 .

The American Society of Clinical Oncology (ASCO) convened a subcommittee to develop recommendations on improving the evidence base for treating older adults with cancer in response to a critical need identified by the Institute of Medicine. Older adults experience the majority of cancer diagnoses and deaths and make up the majority of cancer survivors. Older adults are also the fastest growing segment of the US population. However, the evidence base for treating this population is sparse, because older adults are underrepresented in clinical trials, and trials designed specifically for older adults are rare. The result is that clinicians have less evidence on how to treat older adults, who represent the majority of patients with cancer. Clinicians and patients are forced to extrapolate from trials conducted in younger, healthier populations when developing treatment plans. This has created a dearth of knowledge regarding the risk of toxicity in the average older patient and about key end points of importance to older adults. ASCO makes five recommendations to improve evidence generation in this population: (1) Use clinical trials to improve the evidence base for treating older adults with cancer, (2) leverage research designs and infrastructure for generating evidence on older adults with cancer, (3) increase US Food and Drug Administration authority to incentivize and require research involving older adults with cancer, (4) increase clinicians' recruitment of older adults with cancer to clinical trials, and (5) use journal policies to improve researchers' reporting on the age distribution and health risk profiles of research participants.

e16518 Background: Older men are at a high risk for adverse events (AEs) from androgen deprivation therapy (ADT). In this phase II study, we evaluated Enz and Dut/Fin in lieu of ADT for at-risk older patients with HNSPCa. Methods: Eligible patients were ≥65 years (y); at high risk of AEs from ADT by GA or treating physicians; metastatic (M1) or non-metastatic (M0) HNSPCa with a PSA doubling time ≤ 9 months and testosterone > 50ng/dl. They received Enz 160 mg/day and Dut 0.5 mg/day or Fin 5 mg/day until disease progression. GA was performed at baseline and week (wk) 61 and/or at the time of progression. GA included validated tests: Instrumental Activities of Daily Living (IADL), fall history, Short Physical Performance Battery (SPPB), Geriatric Depression Scale (GDS), and Montreal Cognitive Assessment (MOCA). The prevalence of impairment for each assessment was calculated; change in prevalence from baseline to wk 61 was analyzed using paired sample t-test. Results: 43 patients were enrolled in the study. Median age at enrollment was 78 y (range 66-94) and 93% were ECOG 0-1; 37% (n = 16) had M0 and 63% (n = 27) had M1 HNSPCa, with the majority (67%) having Gleason 6 or 7 disease. At baseline, 18.6% met the cutoff for impairment for IADLs, 53.7% for SPPB, 7.9% for GDS and 64.3% for MOCA; 9.8% had a recent fall. Median baseline PSA was 11.38 ng/ml (range: 2-145). At the time of analysis, 29 men (67.4%) remain on study treatment. 95.3%, 74.4% and 46.5% of patients reported at least one Grade 1, 2 or 3 AE respectively. No patient had a Grade 4 AE and one Grade 5 AE was reported but was an unrelated event. The most common Grade 3 AEs were hypertension (27.8%), GI (19.4%), and cardiac (8.3%); all Grade 3 GI AEs reported were deemed unrelated to the study drugs. Only impairment in ≥ 1 IADL showed a statistically significant increase in prevalence at wk 61 of treatment (40.6%) compared to baseline (18.6%, p = 0.036). Conclusions: For older men with HNSPCa, Enz with Dut/Fin demonstrated efficacy with reasonable toxicity profile, and no significant impact on the majority of GA domains. Clinical trial information: NCT02213107.

11544 Background: Older patients with advanced cancer face considerable uncertainty related to their disease and treatment. The aim of our study was to evaluate the associations of uncertainty with psychological status and QoL. Methods: This is a secondary analysis of baseline data from a national geriatric assessment (GA) cluster randomized trial (URCC 13070; PI: Mohile). Patients aged ≥70 years with ≥1 GA domain impairment (e.g., function, cognition) and advanced cancer who were considering or receiving any line of cancer treatment were enrolled (n=541). Uncertainty was measured using the modified 9-item Mishel Uncertainty in Illness (MUIS), where respondents with higher scores perceive more uncertainty (range 9-45). QoL and psychological measures consisted of Functional Assessment of Cancer Therapy-General (FACT-G), emotional wellbeing (EWB; FACT-G subscale), distress (distress thermometer), anxiety (Generalized Anxiety Disorder-7), and depression (Geriatric Depression Scale-15). Multiple linear regressions were used to evaluate the associations of MUIS scores with each measure, adjusted for demographics, cancer type, and number of impaired GA domains. Results: Mean age was 77 years (SD 5, range 70-96); 26% had gastrointestinal cancer and 26% had lung cancer. Mean number of GA domain impairments was 4 (SD 1, range 1-7). Mean MUIS score was 20 (SD 5, range 9-37). On multivariate analyses, higher MUIS score was associated with lower QoL (β=-1.08, SE=0.11) and EWB (β=-0.29, SE=0.03), as well as higher distress (β=0.12, SE=0.02), anxiety (β=0.11, SE=0.04), and depression (β=0.09, SE=0.03; all P

e18131 Background: Multiple studies have described the barriers and facilitators to oncology clinical trial accrual in academic practices. However, few studies have been done in community settings, even though the majority of patients with cancer receive their care in the community. We examined and compared community and academic oncologists’ perceptions of the barriers and facilitators to cancer clinical trial accrual. Methods: Semi-structured interviews were conducted from March to June 2018 with 44 medical oncologists at City of Hope (24 in academia; 20 in community sites). Purposive sampling was used to ensure participant diversity. Primary measures were oncologists’ self-reported perceptions of the barriers and facilitators to clinical trial accrual. Responses were recorded digitally, transcribed, and de-identified. Data was managed using NVivo v12. Two analysts coded the interview data using thematic content analysis (kappa = 0.74). A third analyst adjudicated discrepancies. Results: Of the 44 participants, 36% were women, and 68% had > 10 years of experience. Compared to academic oncologists, community oncologists more often cited barriers due to the lack of protocols suitable for community patients’ histology and stage (13% vs. 6%) and insufficient trial personnel support (13% vs. 9%). Compared to community oncologists, academic oncologists more often cited barriers due to limited time (14% vs. 8%) and overly stringent eligibility criteria (14% vs. 9%). Community oncologists more commonly reported extrinsic facilitators (e.g. reminders of available protocols from trial support staff) (91% vs. 76%) while academic oncologists more commonly reported intrinsic facilitators for offering clinical trials (e.g. self-motivation to prioritize clinical trials) (24% vs. 9%). Conclusions: Community oncologists more often reported facing barriers to accrual due to limited suitable trials and insufficient personnel support compared to academic oncologists. Additionally, community oncologists cite the need for more infrastructure to support accrual. Interventions to increase trial accrual must be tailored to address the unique needs of both community and academic practices.

e18130 Background: Despite the disproportionate impact of cancer on older adults, older patients are vastly underrepresented in clinical trials that set the standards for cancer treatment. To better understand the reasons for this disparity, we conducted a systematic review of studies that have specifically examined barriers and interventions to improve clinical trial enrollment of older adults with cancer. Methods: We conducted a comprehensive two-step search strategy. First, we consulted an information specialist to develop an electronic search for the following databases from inception to January 15, 2019: PubMed, Ovid/Medline, Embase, Scopus, PsycINFO, and Cochrane library. Second, references of retrieved key articles were screened for relevant studies. Two authors then independently reviewed all titles and abstracts (N = 10,985) and examined studies for full text eligibility (N = 221). Inclusion criteria were: 1) original research; 2) study assessed barriers and/or interventions to enrollment in oncology clinical trials; 3) included patients ≥ 60 years with cancer. Narrative reviews and abstracts without full text were excluded. Data was extracted by independent raters and summarized using a qualitative analysis software, NVivo v12. Results: 12 observational studies examining barriers and 1 randomized intervention were included. Barriers were assessed at the patient level (N = 5 studies), healthcare professional (HCP) level (N = 5), and both patient and HCP levels (N = 2). Stringent eligibility criteria (N = 7) and oncologists’ concerns for toxicity (N = 7) were the most common barriers cited. Patient barriers included transportation (N = 6), time/burden (N = 6), and awareness (N = 6). Although caregiver barriers (N = 4) were identified, none of the studies examined caregiver perceptions. One study evaluated a physician-directed educational intervention and found no significant impact on accrual of older adults. Conclusions: Although several studies have examined the barriers to accrual of older adults with cancer, only one intervention study has attempted to address these barriers. Given the aging of the cancer population, new strategies for including older adults in cancer clinical trials are critically needed.

11523 Background: Quality person-centered care relies on effective communication between the clinical team and the patient/caregiver eliciting goals and discussing wishes. In a PCORI- and NCI-funded CRCT, we found that providing community-based oncologists with geriatric assessment-guided recommendations led to more and higher quality discussions of age-related issues for older patients with advanced cancer. In this secondary analysis, we assessed whether specific recommendations to oncologists to discuss patient goals, proxy and advance directives resulted in increased communication about these topics. Methods: Patients aged 70+ with advanced solid tumors or lymphoma and at least one impaired geriatric domain (e.g., function, cognition) were enrolled (URCC 13070; PI: Mohile). Oncology practices were randomized to the intervention (oncologists received recommendations to elicit goals and discuss wishes) or usual care. The clinic visit after the oncologist received recommendations was recorded and transcribed; two blinded coders evaluated the transcripts for discussion of the specific topic areas recommended in the intervention. Between arm differences were compared using generalized linear models controlling for practice cluster. Results: From 2014-17, 528 patients (284 intervention) provided transcripts from 31 practices (mean age = 77, range 70-96 years; 49% female; mixed cancer diagnoses). Topics related to patient goals, proxy and advance directive wishes were more often discussed in the intervention arm (goals of care preferences: 9 vs 2%, p = .02, treatment goals: 35 vs 20%. p = .04, elicit caregiver input: 28 vs 3%. p < .01, assess values and goals: 25 vs 7%, p = .07, health care proxy: 40 vs 1%, p = .004, advance directive: 25 vs 1%, p = .002). Conclusions: In this community-based study of older adults providing recommendations to oncologists to discuss specific topics resulted in increased person-centered discussions with patients and caregivers about goals, proxy and advance directive wishes. However, the content areas were discussed in less than half of all visits. Clinical trial information: NCT02107443.

6539 Background: American Society of Clinical Oncology guidelines recommend that patients ≥65 years of age starting chemotherapy undergo a geriatric assessment (GA) to inform and guide management; however, little is known about resources available in community oncology practices to facilitate geriatric specialty care and implement these guidelines. Methods: Community oncology practices were electronically surveyed in 2017 regarding the availability of various providers, supportive services, and practice characteristics, as part of a larger survey of cancer care delivery research (CCDR) capacity at NCORP sites. Designated CCDR leads provided information about their site. Descriptive statistics were used to report prevalence of resources available at each community practice. Results: Of the 925 NCORP practice locations, 504 (54%) responded to the survey, representing 227 practice groups. Of respondents, 58% included a free-standing clinic or private/group practice and 82% included inpatient services. The median number of new cancer cases per year ≥65 years of age was 443 (Interquartile range [IQR] 220-903). The median number of medical oncology providers was 5 (IQR 3-11). Only 1.8% of practices had a dual fellowship trained geriatric oncologist on staff. Geriatricians were available for consultation or co-management for 34% of sites, but only 13% of those had availability within the oncology clinic. Among those with access to geriatricians, consultations were primarily outpatient (90%) versus inpatient (54%). Ancillary services that could support GA were variably available onsite: social work (83%), nurse navigators (78%), pharmacist (77%), dietician (69%), supportive caregiver services (62%), rehabilitative medicine (57%), psychologist (41%), and psychiatrist (39%). Most sites utilized electronic health record systems (84%) and patient portals (89%). Conclusions: Availability of geriatric-trained providers is limited in community oncology practices. Use of primarily self-administered GA tools that direct referrals to available ancillary services may be an effective implementation strategy for guideline-based care.

11549 Background: Oncologists often struggle with managing the unique care needs of older adults with cancer. We sought to determine the feasibility of delivering a transdisciplinary geriatric intervention designed to address the geriatric (physical function & comorbidity) and palliative care (symptoms & prognostic understanding) needs of older adults with cancer. Methods: We randomly assigned patients age ≥65 with newly diagnosed incurable gastrointestinal (GI) or lung cancer to receive a transdisciplinary geriatric intervention or usual care. Intervention patients received two visits with a geriatrician who was trained to address patients’ palliative care needs in addition to conducting a geriatric assessment. We defined the intervention as feasible if > 70% of patients enrolled in the study and > 75% completed study visits and surveys. At baseline and week 12, we assessed patients’ quality of life (QOL, Functional Assessment of Cancer Therapy General), symptoms (Edmonton Symptom Assessment System), and communication confidence (Perceived Efficacy in Patient Physician Interactions). As this was a pilot study, we calculated mean change scores in outcomes and estimated intervention effect sizes (ES). Results: From 2/2017-6/2018, we randomized 62 patients (55.9% enrollment rate [most common reason for refusal was feeling too ill]; median age = 72.3 [range 65.2-91.8]; 45.2% female; cancer types: 56.5% GI, 43.5% lung). Among intervention patients, 82.1% attended the first visit and 76.2% attended both. Overall, 77.8% completed all study surveys. Compared to usual care, intervention patients had less decrement in QOL scores (-0.77 vs -3.84, ES = .21), greater reduction in the number of moderate/severe symptoms (-0.69 vs +1.04, ES = .58), and more improvement in communication confidence (+1.06 vs -0.80, ES = .38). Conclusions: In this trial of older adults with advanced cancer, more than half enrolled in the study and over 75% of those who enrolled completed all study visits and surveys. Our effect size estimates suggest that a transdisciplinary intervention targeting patients’ geriatric and palliative care needs may be a promising approach to improve patients’ QOL, symptom burden, and communication confidence. Clinical trial information: NCT02868112.

11556 Background: Anxiety and depression are associated with decreased quality of life, treatment adherence, and survival in patients with cancer. Mental Health Inventory (MHI-17) is a validated screening tool for psychological well-being, but cut points for older adults with cancer are unknown. The goal of this study is to identify cut points on MHI-17 Anxiety (MHI-A) and Depression (MHI-D) subscales which correlate with patient-reported anxiety and depression in older adults with cancer. Methods: This is a secondary analysis of baseline data from a randomized controlled trial in adults aged 65+ with solid tumors starting chemotherapy. At baseline, patients completed MHI-17. MHI-A and MHI-D were calculated (range 0-100; higher scores represent better mental health). Self-reported anxiety was obtained from single-item Linear Analog Scale Assessment (0-5 = low, 6-10 = high). Self-reported depression was obtained from Yale Depression Screen, “Do you often feel sad or depressed?” The association of MHI-A and MHI-D with the patient-reported outcomes was analyzed using logistic regression. Youden’s index was used to determine the optimal cut points for MHI-A and MHI-D for identifying patients with high anxiety and depression. Results: 458 patients (median age 71 (range 65-91), 57% female, 55% non-Hispanic white) were included in this analysis. The most common cancer types were: GI (31%), breast (19%), GU (18%), and pulmonary (16%); 75% had stage IV cancer. Twenty-four percent (N = 110) reported high anxiety and 21% (N = 97) depression. Median scores for MHI-A and MHI-D were 75 (range 0-100) and 80 (range 0-100). The optimal cut point for high anxiety on MHI-A was 65; this had an accuracy of 76.1%, a sensitivity of 71.8%, and a specificity of 77.5%. The optimal cut point for depression on MHI-D was 70; this had an accuracy of 80.1%, a sensitivity of 80.4%, and a specificity of 79.8%. Conclusions: The current study identified optimal cut points for MHI-Anxiety and MHI-Depression subscales to identify older adults with cancer starting chemotherapy with self-reported anxiety and depression. In the absence of patient-reported anxiety and depression, these cut points could be used to identify older patients with cancer at risk for poor mental health.

11625 Background: Improving body image and self-esteem are top ASCO priorities in the survivorship care of men with prostate cancer (PCa). Body image and global self-esteem, influenced by physical self-worth, are negatively affected by PCa treatment. We investigate whether exercise can improve physical self-worth in men treated for PCa and if improving self-worth is associated with changes in quality of life (QoL) and mental health. Methods: We performed a secondary analysis of a phase II randomized controlled trial comparing the effects of Exercise for Cancer Patients(EXCAP), a structured, 6-week, home-based exercise intervention, to usual care (UC) in men with non-metastatic PCa receiving radiation or Androgen Deprivation Therapy (ADT). The Physical Self-Perception Profile (PSPP), a valid 30-item questionnaire where higher scores indicate greater physical self-worth, was assessed at pre- and post-intervention. Changes between arms were compared using ANCOVA. Spearman correlations were calculated for pre/post-intervention change scores for PSPP and QoL, depression, and anxiety as measured by the Functional Assessment of Cancer Therapy (FACT), Center of Epidemiologic Studies Depression (CES-D) scale, and State-Trait Anxiety Inventory (STAI), respectively. Results: Fifty-eight men were randomized; average age was 67.1 years. Physical self-worth at baseline moderated the effect of the intervention. Compared to UC, EXCAP improved physical self-worth in those with baseline PSPP scores above the median (p < 0.04). Exercisers with baseline PSPP scores in the top quartile demonstrated a more significant improvement over UC (p < 0.01). Improvements in physical self-worth were associated with improved QoL (r = 0.29, p = 0.04), depression (r = -0.28, p = 0.04) and anxiety (r = -0.30, p = 0.03). Conclusions: Exercise significantly improves physical self-worth in men with PCa on radiation or ADT, and greater physical self-worth is associated with improved QoL, depression and anxiety. Those with higher baseline physical self-worth derived the most benefit from exercise. Exercise should be prescribed to boost self-esteem and body image in men receiving radiation or ADT for PCa. Clinical trial information: NCT00815672.

e18066 Background: Social media may be an effective strategy to improve public awareness of oncology clinical trials and increase accrual. How oncologists perceive the role of social media in clinical trials now and in the future remains unknown. We explored oncologists’ attitudes and perceptions related to social media and clinical trial recruitment. Methods: Semi-structured interviews were conducted with 44 medical oncologists at City of Hope from March to June 2018. Primary measures were oncologists’ self-reported benefits, concerns, and future interventions to leverage social media for trial recruitment. Secondary measures were facilitators and barriers to social media use for professional purposes. Responses were recorded digitally, transcribed, and de-identified. Data was managed using NVivo v12. Two analysts coded interview data using thematic content analysis (kappa = 0.7). Results: Of the 44 participants, 55% were academic and 45% were community oncologists, 36% were women, and 68% had > 10 years of experience. The most commonly cited benefit was increased awareness and visibility (63%). The most commonly cited concerns were: lack of time or support (31%), misinformation or oversimplification (31%), and lack of guidance (regulatory/ethical oversight) (28%). Oncologists reported a desire for an institutional-level intervention (e.g., personnel support with social media expertise) to facilitate trial recruitment using social media (50%). Oncologists’ perceptions of the facilitators to social media use for professional purposes were centered on networking (40%) and staying up to date in the field (33%). Perceived barriers were clustered around lack of comfort, training, time (38%), and lack of evidence of benefit (25%). No differences were identified between academic and community oncologists. Conclusions: Oncologists are hopeful that social media can increase awareness and visibility of cancer clinical trials. However, they have numerous concerns about the application of social media in clinical trials due to lack of time, support, and risk of misinformation. Further research is needed to examine whether social media can facilitate recruitment to oncology clinical trials.

11524 Background: Accurate prognostic understanding facilitates the receipt of goal-concordant medical care. Few studies have evaluated prognostic understanding in patients with hematologic malignancies. In this secondary analysis of a multicenter, longitudinal study of patients with hematologic malignancies referred for a second opinion hematology subspecialty consultation, we assessed changes in prognostic understanding after consultation, and predictors of post-consultation patient-oncologist prognostic discordance. Methods: Patients were recruited from 4 academic centers. Before and 1-7 days after consultation, patients were asked about their perceived chance of cure (options < 10%, 10-19%, and up to 90-100% in 10% increments, and “do not wish to answer”). Oncologists were asked the same question after consultation. Discordance was defined as a difference in response by 2 levels in the patient-oncologist dyads. We used multivariate analysis to assess the demographic and clinical predictors of patient-oncologist discordance. Results: We included 216 patients (median age 55 years, range 22-79) and 46 oncologists (47, 30-70). Overall, ≥On multivariate analysis, discordance before consultation [Odds Ratio (OR) 6.05, 95% Confidence Interval (CI) 2.96-12.36) and < college education (vs. post-graduate education; OR 2.34, 95% CI 1.09-5.14) were associated with discordance after consultation. Other patient demographics, comorbidity, cancer type, psychological distress, social support, decision-making preference, and coping strategies were not associated with discordance. Conclusions: Patient-oncologist concordance in prognostic understanding improved after subspecialty consultation, but over half of patients’ views of their prognosis remained discordant with those of their oncologists. Interventions to improve patient-oncologist communication about prognosis are needed, especially in patients with lower education level.

20 Background: Older patients with advanced cancer who are certain that they could be cured pose unique challenges for physicians who wish to help them prepare for death. By estimating the prevalence of absolute certainty about curability (ACC) and examining its correlates we aim to inform the development of interventions to improve end of life care. We hypothesized that patients who report greater willingness to bear adversity in exchange for longevity will be more likely to demonstrate ACC. Methods: This is a cross-sectional analysis of a nationwide geriatric assessment trial. Patients were asked: “What are the chances the cancer will go away and never come back with treatment [100% (ACC), > 50%, 50/50, < 50%, 0%, or unclear].” We assessed willingness to bear adversity using two types of trade-off questions. For trade-offs between treatment-related adverse reactions and survival, five statements on specific adverse reactions (nausea/vomiting, assistance with activities, bedbound state, confusion, worsening memory) were administered. For trade-off preferences between quality of life (QoL) and survival, patients answered the following statement: “Maintaining my QoL is more important to me than living longer”. Logistic regression was used to assess the independent associations of patient trade-off preferences with ACC, after controlling for covariates. Results: 349 older patients were included; 8.0% had ACC. 7.4% of respondents disagreed/strongly disagreed with the statement “Maintaining my QoL is more important than living longer.” Patients who were willing to trade QoL for survival were more likely to demonstrate ACC (AOR 4.43, 95% CI 1.13-17.42). Trade-off preferences between adverse reactions and survival were not associated with ACC. Non-white race, < high school education, lower household income, lack of social support, intact functional status, and no polypharmacy were associated with ACC (p < 0.05). Conclusions: Patients with advanced cancer who are more willing to accept a decreased QoL for survival are more likely to be certain that they will be cured. Beyond sharing prognosis, clinicians might help patients improve prognostic understanding by helping them identify and articulate their values and beliefs.

Overview: The incidence of cancer increases with age. Oncologists need to be adept at assessing physiologic and functional capacity in older patients in order to provide safe and efficacious cancer treatment. Assessment of underlying health status is especially important for older patients with advanced cancer, for whom the benefits of treatment may be low and the toxicity of treatment high. The comprehensive geriatric assessment (CGA) is the criterion standard for evaluation of the older patient. The combined data from the CGA can be used to stratify patients into categories to better predict risk for chemotherapy toxicity as well as overall outcomes. The CGA can also be used to identify and follow-up on possible functional consequences from treatment. A variety of screening tools might be useful in the oncology practice setting to identify patients who may benefit from further testing and intervention. In this chapter, we discuss how the principles of geriatrics can help improve the clinical care of older adults with advanced cancer. Specifically, we discuss assessing tolerance for treatment, options for chemotherapy scheduling and dosing for older patients with advanced cancer, and management of under-recognized symptoms in older patients with cancer.

Purpose Older adults are vulnerable to chemotherapy toxicity; however, there are limited data to identify those at risk. The goals of this study are to identify risk factors for chemotherapy toxicity in older adults and develop a risk stratification schema for chemotherapy toxicity. Patients and Methods Patients age ≥ 65 years with cancer from seven institutions completed a prechemotherapy assessment that captured sociodemographics, tumor/treatment variables, laboratory test results, and geriatric assessment variables (function, comorbidity, cognition, psychological state, social activity/support, and nutritional status). Patients were followed through the chemotherapy course to capture grade 3 (severe), grade 4 (life-threatening or disabling), and grade 5 (death) as defined by the National Cancer Institute Common Terminology Criteria for Adverse Events. Results In total, 500 patients with a mean age of 73 years (range, 65 to 91 years) with stage I to IV lung (29%), GI (27%), gynecologic (17%), breast (11%), genitourinary (10%), or other (6%) cancer joined this prospective study. Grade 3 to 5 toxicity occurred in 53% of the patients (39% grade 3, 12% grade 4, 2% grade 5). A predictive model for grade 3 to 5 toxicity was developed that consisted of geriatric assessment variables, laboratory test values, and patient, tumor, and treatment characteristics. A scoring system in which the median risk score was 7 (range, 0 to 19) and risk stratification schema (risk score: percent incidence of grade 3 to 5 toxicity) identified older adults at low (0 to 5 points; 30%), intermediate (6 to 9 points; 52%), or high risk (10 to 19 points; 83%) of chemotherapy toxicity (P < .001). Conclusion A risk stratification schema can establish the risk of chemotherapy toxicity in older adults. Geriatric assessment variables independently predicted the risk of toxicity.

Purpose To identify whether a history of cancer is associated with specific geriatric syndromes in older patients. Patients and Methods Using the 2003 Medicare Current Beneficiary Survey, we analyzed a national sample of 12,480 community-based elders. Differences in prevalence of geriatric syndromes between those with and without cancer were estimated. Multivariable logistic regressions were used to evaluate whether cancer was independently associated with geriatric syndromes. Results Two thousand three hundred forty-nine (18%) reported a history of cancer. Among those with cancer, 60.3% reported one or more geriatric syndromes as compared with 53.2% of those without cancer (P < .001). Those with cancer overall had a statistically significantly higher prevalence of hearing trouble, urinary incontinence, falls, depression, and osteoporosis than those without cancer. Adjusting for possible confounders, those with a history of cancer were more likely to experience depression (adjusted odds ratio [OR], 1.15; 95% CI, 1.02 to 1.30; P = .023), falls (adjusted OR, 1.17; 95% CI, 1.04 to 1.32; P = .010), osteoporosis (adjusted OR, 1.21; 95% CI, 1.06 to 1.38; P = .004), hearing trouble (adjusted OR, 1.28; 95% CI, 1.08 to 1.52; P = .005), and urinary incontinence (adjusted OR, 1.42; 95% CI, 1.20 to 1.69; P < .001). Analysis of specific cancer subtypes showed that lung cancer was associated with vision, hearing, and eating trouble; prostate cancer was associated with incontinence and falls; cervical/uterine cancer was associated with falls and osteoporosis; and colon cancer was associated with depression and osteoporosis. Conclusion Elderly patients with cancer experience a higher prevalence of geriatric syndromes than those without cancer. Prospective studies that establish the causal relationships between cancer and geriatric syndromes are necessary.

87 Background: Financial toxicity (FT), or the stress and strain patients (pts) experience as a result of paying for cancer care, can have profound negative impacts on pts’ overall quality of life (QoL). This study examined associations of FT with anxiety, depression, and QoL in older pts with advanced cancer. Methods: This is a secondary analysis of baseline data from a Geriatric Assessment intervention study conducted by UR NCORP across 31 practice sites (PI: Mohile). Pts were categorized as experiencing FT if they reported any one of the following: delaying medications due to cost, insufficient income in a typical month for food and housing, or insufficient income in a typical month for other basic needs. Pts also completed the Generalized Anxiety Disorder-7 (GAD7, score 0-21) to evaluate anxiety, the Geriatric Depression Scale (GDS, score 0-15) to assess depression, and the Functional Assessment of Cancer Therapy- Generation (FACT-G, score 0-108), to measure overall QoL. Associations of FT with anxiety, depression, and QoL were assessed in separate multivariate linear regression models controlling for covariates at p < 0.1. Results: Among 542 pts (mean age 77; range 70-96, 49% female), 18% (98 pts) experienced FT. In separate regression analysis, FT was significantly associated with all 3 outcome measures. On average, pts experiencing FT scored 1.76 higher (p < 0.01) on the GAD7 (indicating greater anxiety severity), 0.76 points higher (p = 0.02) on the GDS (indicating greater depression severity), and 5.16 points lower (p < 0.01) on the FACT-G (indicating lower QoL). Conclusions: Older pts with advanced cancer who experience income and cost-related barriers to quality cancer care reported worse anxiety, depression, and QoL than those without FT. Given the association between FT and these outcomes, these 3 FT questions may help identify vulnerable older pts and allow providers to intervene sooner and thereby enhance the quality of care pts receive.

LBA10003 Background: GA includes validated measures that assess age-related health domains (e.g., function, cognition) known to increase adverse outcomes. In this PCORI and NCI funded CRCT, we evaluated if providing a GA summary and recommendations for GA-guided interventions improves communication about age-related concerns for older patients (pts) with cancer. Methods: Pts aged ≥ 70 with advanced solid tumors or lymphoma and at least 1 impaired GA domain were enrolled. Oncology practices were randomized to intervention (oncologists received GA summary) or usual care (no summary provided). The primary outcomes were: 1) number of discussions about age-related concerns (the clinic visit after GA was audio-recorded and transcribed; 2 blinded coders evaluated quality of communication and plan for follow-up interventions) and 2) telephone surveys of patient satisfaction (modified Health Care Climate Questionnaire [HCCQ-age] scored 7-35). Outcomes were analyzed using linear mixed models with arm as the fixed effect, controlling for practice. Results: From 2014-17, 544 pts (295 in GA) were enrolled from 31 practices. There were no differences in demographics by arm (mean age 77 yrs; 49% female). More patients in usual care had impaired physical performance (96% vs 92%, p = 0.03) and social support (33% vs 25%, p = 0.05). In 530 evaluable pts, the overall mean number of discussions was 6.3 (SD: 4.0). The GA arm had 3.5 more discussions about age-related concerns (95%CI: 2.28-4.72, p = 10-6; intraclass correlation coefficient [ICC] = 0.24) compared to usual care; of these, in the GA arm, 2.0 more discussions on average had higher quality communication (95%CI: 1.20-2.69; p = 6x10-6) and 1.9 more led to interventions (95% CI: 1.14-2.73; p = 1.6x10-5). The GA arm had significantly more discussions for almost all GA domains. In 511 pts with HCCQ-age, the mean score was 22.9 (SD 4.5); the score was 1.12 points higher in the GA arm (95%CI: 0.23-2.03; p = .027; ICC = 0.02). Conclusions: Providing a GA summary to oncologists increases the number and quality of discussions about age-related concerns and improves pt satisfaction. Clinical trial information: NCT02107443.

e22025Background: Few studies have focused on disparities in healthcare communication between black vs. white older (age 70+) patients with advanced cancer, and fewer have evaluated mechanisms unde...

e22037Background: Financial toxicity, or the strain caused by paying for health care services, can undermine the mental health and QoL of patients (pts) in cancer care. This study examined associat...

10099Background: Frailty is an important factor for oncologists in determining risk of chemotherapy toxicity, especially for older adults. While inflammation has been associated with survival, its ...

e22034Background: Older patients (pts) with cancer have more chemotherapy (chemo) toxicities leading to dose modifications. Few studies have evaluated the association of concomitant medications (me...

10118Background: Pain is a highly prevalent side effect of breast cancer therapy. High pain levels can reduce treatment adherence and increase discontinuation rates for hormonal therapies (HT) whil...

e18707Background: Investigating CIPN prevention and treatment strategies is a high priority that could be pursued with claims data. However, no studies have investigated the feasibility of identify...

10048Background: The prevalence of CI and the utility of CI screening for community oncology practices are not well established. We used two tools to screen for CI in older patients (pts) enrolled ...

10043Background: More than 60% of patients diagnosed with MM are > 65 years old and at greater risk for treatment toxicity. Comprehensive geriatric assessment predicts toxicity and survival but is ...

108 Background: Exercise ameliorates cancer and treatment-related toxicities but adherence to exercise is a barrier. Few studies in the general population suggest that E-DAT may improve exercise adherence. We conducted a systematic review to examine the effects of E-DAT on physical function, health-related quality of life (HRQOL), and serum inflammatory markers during and after cancer treatment. Methods: We used PubMed, Embase, and the Cochrane Library to identify RCTs of E-DAT in cancer patients aged ≥18 years published in English between 1/1/2008 and 7/27/2017. Two authors independently reviewed the titles of articles from the search (n = 160), removed duplicates (n = 49), and reviewed the remaining 111 articles for eligibility and substantive results. We excluded RCTs that used digital activity trackers solely for data collection. Results: Twelve RCTs met eligibility criteria, including 1,450 patients (mean age: 50-70 years) with the following cancers: breast (n = 5 RCTs), colon or breast (n = 2), prostate (n = 1), acute leukemia (n = 1) and various type (n = 3). Duration of E-DAT ranged from 4-24 weeks. Follow-up period was 4-24 weeks with retention of 54-95%. Half of the RCTs had E-DAT with in-person exercise training and the rest had self-directed training. The technology component of E-DAT included pedometers (n = 8); pedometers with smart phone application (n = 1), Wii-Fit (n = 1), or heart rate monitor (n = 1); and a wireless sensor with accelerometer, gyroscope, and magnetometer (n = 1). Adherence to E-DAT was > 70% in 5 of 7 RCTs. Compared to controls (exercise interventions without digital activity trackers or standard of care), E-DAT significantly improved the step count in 60% of 5 RCTs, activity level in 56% of 9 RCTs, and HRQOL in 56% of 9 RCTs (all p < 0.05), with no significant changes of inflammatory markers (i.e. TNF, CRP, c-peptide) in 2 RCTs. No significant correlations were found between duration of E-DAT with adherence (Spearman’s r = 0.16; p = 0.75) or study retention (Spearman’s r = -0.42; p = 0.17). Conclusions: This systematic review shows that E-DAT is feasible to implement in cancer patients. Future research should examine the optimal type, dose and schedule of E-DAT.

Purpose Androgen deprivation therapy (ADT) is first-line therapy for patients with prostate cancer (PCA) who experience biochemical recurrence (BCR). However, the optimal timing of ADT initiation is uncertain, and earlier ADT initiation can cause toxicities that lower quality of life (QOL). We tested the hypothesis that elevated cancer anxiety leads to earlier ADT initiation for BCR in older men. Patients and Methods We conducted a prospective cohort study of older patients with BCR of PCA (n = 67). Patients completed questionnaires at presentation and each follow-up visit until initiation of ADT. PCA-specific anxiety was measured with the Memorial Anxiety Scale for Prostate Cancer (MAX-PC). Other collected data included demographics, clinical information, and general anxiety information. Treating oncologists were surveyed about their recommendations for ADT initiation. The primary outcome was the time to ADT initiation. Univariate, multivariate logistic regression, and time-to-event analyses were conducted to evaluate whether cancer anxiety was a predictor of earlier initiation of ADT. Results Thirty-three percent of patients initiated ADT at the first or second clinic visit. Elevated PCA anxiety (MAX-PC > 16) was the most robust predictor in multivariate analyses of early initiation (odds ratio [OR], 9.19; P = .01). PSA also independently correlated with early initiation (OR, 1.31; P = .01). PSA did not correlate with MAX-PC. Conclusion Cancer anxiety independently and robustly predicts earlier ADT initiation in older men with BCR. For older patients with PCA, earlier ADT initiation may not change life expectancy and can negatively impact QOL. PCA-specific anxiety is a potential target for a decision-making intervention in this setting.