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ABSTRACT Background Interindividual variability in oncology patients' symptom experiences poses significant challenges in prioritizing symptoms for targeted intervention(s). In this study, computational approaches were used to unbiasedly characterize the heterogeneity of the symptom experience of oncology patients to elucidate symptom patterns and drivers of symptom burden. Methods Severity ratings for 32 symptoms on the Memorial Symptom Assessment Scale from 3088 oncology patients were analyzed. Gaussian Graphical Model symptom networks were constructed for the entire cohort and patient subgroups identified through unsupervised clustering of symptom co‐severity patterns. Network characteristics were analyzed and compared using permutation‐based statistical tests. Differences in demographic and clinical characteristics between subgroups were assessed using multinomial logistic regression. Results Network analysis of the entire cohort revealed three symptom clusters: constitutional, gastrointestinal‐epithelial, and psychological. Lack of energy was identified as central to the network which suggests that it plays a pivotal role in patients' overall symptom experience. Unsupervised clustering of patients based on shared symptom co‐severity patterns identified six patient subgroups with distinct symptom patterns and demographic and clinical characteristics. The centrality of individual symptoms across the subgroup networks differed which suggests that different symptoms need to be prioritized for treatment within each subgroup. Age, treatment status, and performance status were the strongest determinants of subgroup membership. Conclusions Computational approaches that combine unbiased stratification of patients and in‐depth modeling of symptom relationships can capture the heterogeneity in patients' symptom experiences. When validated, the core symptoms for each of the subgroups and the associated clinical determinants may inform precision‐based symptom management.

Abstract Background By 2035, the number of newly diagnosed cancer cases will double and over 50% will be in older adults. Given this rapidly growing demographic, a need exists to understand how age influences oncology patients’ symptom burden. The study purposes were to evaluate for differences in the occurrence, severity, and distress of 38 symptoms in younger (

BackgroundInterest in the application of predictive risk models (PRMs) in health care to identify people most likely to experience disease and treatment-related complications is increasing. In cancer care, these techniques are focused primarily on the prediction of survival or life-threatening toxicities (eg, febrile neutropenia). Fewer studies focus on the use of PRMs for symptoms or supportive care needs. The application of PRMs to chemotherapy-related symptoms (CRS) would enable earlier identification and initiation of prompt, personalized, and tailored interventions. While some PRMs exist for CRS, few were translated into clinical practice, and human factors associated with their use were not reported. ObjectiveWe aim to explore patients’ and clinicians’ perspectives of the utility and real-world application of PRMs to improve the management of CRS. MethodsFocus groups (N=10) and interviews (N=5) were conducted with patients (N=28) and clinicians (N=26) across 5 European countries. Interactions were audio-recorded, transcribed verbatim, and analyzed thematically. ResultsBoth clinicians and patients recognized the value of having individualized risk predictions for CRS and appreciated how this type of information would facilitate the provision of tailored preventative treatments or supportive care interactions. However, cautious and skeptical attitudes toward the use of PRMs in clinical care were noted by both groups, particularly in relationship to the uncertainty regarding how the information would be generated. Visualization and presentation of PRM information in a usable and useful format for both patients and clinicians was identified as a challenge to their successful implementation in clinical care. ConclusionsFindings from this study provide information on clinicians’ and patients’ perspectives on the clinical use of PRMs for the management of CRS. These international perspectives are important because they provide insight into the risks and benefits of using PRMs to evaluate CRS. In addition, they highlight the need to find ways to more effectively present and use this information in clinical practice. Further research that explores the best ways to incorporate this type of information while maintaining the human side of care is warranted. Trial RegistrationClinicalTrials.gov NCT02356081; https://clinicaltrials.gov/study/NCT02356081

Abstract Background Shortness of breath occurs in 10%–70% of oncology patients. Very little is known about interindividual variability in its severity and distress and associated risk factors. Using latent profile analyses (LPAs), purpose was to identify subgroups of patients with distinct severity and distress profiles for shortness of breath as single symptom dimensions. In addition, a joint LPA was done using patients' severity AND distress ratings. For each of the three LPAs, differences among the shortness of breath classes in demographic, clinical, symptom, stress, and resilience characteristics were evaluated. Methods Patients completed ratings of severity and distress from shortness of breath a total of six times over two cycles of chemotherapy. All of the other measures were completed at enrollment (i.e., prior to the second or third cycle of chemotherapy). Separate LPAs were done using ratings of severity and distress, as well as a joint analysis using severity AND distress ratings. Differences among the latent classes were evaluated using parametric and nonparametric tests. Results For severity, two classes were identified (Slight to Moderate [91.6%] and Moderate to Severe [8.4%]). For distress, two classes were identified (A Little Bit to Somewhat [83.9%] and Somewhat to Quite a Bit [16.1%]). For the joint LPA, two classes were identified (Lower Severity and Distress [79.9%] and Higher Severity and Distress [20.1%]). While distinct risk factors were associated with each of the LPAs, across the three LPAs, the common risk factors associated with membership in the worse class included: a past or current history of smoking, poorer functional status, and higher comorbidity burden. In addition, these patients had a higher symptom burden and higher levels of cancer‐specific stress. Conclusions Clinicians can use the information provided in this study to identify high‐risk patients and develop individualized interventions.

Abstract Aim To evaluate older gynecologic oncology patients' quality of life (QOL) at the initiation of chemotherapy and compare their QOL scores with a female age‐matched general population (GP) sample. Design Cross‐sectional. Methods Older (n = 122) gynecologic oncology patients completed the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (QLQ‐C30) that evaluates global health and five functional scales (range from 0 to 100). Differences in QOL scores between our sample and the GP were evaluated using one‐sample t‐tests and effect sizes were calculated using Cohen's d. Results Patients' mean age was 70.7 years (±6.6). Mean scores for the function scales ranged from 58.5 (±31.1) for role function to 86.1 (±17.0) for cognitive function. Compared to the GP, our sample reported significantly lower scores for global health status, social, role and physical functioning, and a significantly higher score for cognitive functioning. No differences were found in emotional functioning scores. Patient or Public Contribution No patient or public contribution.

Abstract Background Evaluate for differences in occurrence, severity, and distress ratings for 32 symptoms between younger older adults (YOA,

While the epidemiological literature recognizes associations between chronic non-cancer pain (CNCP), opioid use disorder (OUD), and interpersonal trauma stemming from physical, emotional, sexual abuse or neglect, the complex etiologies and interplay between interpersonal and structural traumas in CNCP populations are under-examined. Research has documented the relationship between experiencing multiple adverse childhood experiences (ACEs) and the likelihood of developing an OUD as an adult. However, the ACEs framework is criticized for failing to name the social and structural contexts that shape ACE vulnerabilities in families. Social scientific theory and ethnographic methods offer useful approaches to explore how interpersonally- and structurally-produced traumas inform the experiences of co-occurring CNCP, substance use, and mental health. We report findings from a qualitative and ethnographic longitudinal cohort study of patients with CNCP (n = 48) who received care in safety-net settings and their primary care providers (n = 23). We conducted semi-structured interviews and clinical and home-based participant observation from 2018 to 2020. Here we focus our analyses on how patients and providers explained and situated the role of patient trauma in the larger clinical context of reductions in opioid prescribing to highlight the political landscape of the United States opioid overdose crisis and its impact on clinical interactions. Findings reveal the disproportionate burden structurally-produced, racialized trauma places on CNCP, substance use and mental health symptoms that shapes patients’ embodied experiences of pain and substance use, as well as their emotional experiences with their providers. Experiences of trauma impacted clinical care trajectories, yet providers and patients expressed limited options for redress. We argue for an adaptation of trauma-informed care approaches that contextualize the structural determinants of trauma and their interplay with interpersonal experiences to improve clinical care outcomes.

Abstract Background The SARS-CoV-2 (COVID-19) pandemic increased use of telehealth for the management of opioid use disorder and chronic non-cancer pain in primary care safety net clinical systems. Significant barriers to telehealth exist, little is known about how these barriers impact urban safety net, primary care providers and their patients. The objective of this study was to qualitatively assess the benefits and challenges of telehealth for management of chronic non-cancer pain, opioid use disorder, and multi-morbidity in primary care, safety net clinical systems. Methods We interviewed patients with chronic non-cancer pain and history of substance use (n = 22) and their primary care clinicians (n = 7) in the San Francisco Bay Area, March-July 2020. We recorded, transcribed, coded, and content analyzed interviews. Results COVID-19 shelter-in-place orders contributed to increases in substance use and uncontrolled pain, and posed challenges for monitoring opioid safety and misuse through telehealth. None of the clinics used video visits due to low digital literacy/access. Benefits of telehealth included decreased patient burden and missed appointments and increased convenience and control of some chronic conditions (e.g., diabetes, hypertension). Telehealth challenges included loss of contact, greater miscommunication, and less comprehensive care interactions. Conclusions This study is one of the first to examine telehealth use in urban safety net primary care patients with co-occurring chronic non-cancer pain and substance use. Decisions to continue or expand telehealth should consider patient burden, communication and technology challenges, pain control, opioid misuse, and medical complexity.

Abstract Background Moderate to severe fatigue occurs in up to 94% of patients with cancer. Recent evidence suggests that morning and evening fatigue are distinct dimensions of physical fatigue. The purposes of this study were to evaluate the transcriptome for common and distinct perturbed inflammatory pathways in patients receiving chemotherapy who reported low versus high levels of morning or low versus high levels of evening cancer‐related fatigue. Methods Patients completed questionnaires during the week prior to their chemotherapy treatment. Severity of morning and evening fatigue was evaluated using the Lee Fatigue Scale. Gene expression and pathway impact analyses (PIA) were performed in two independent samples using RNA‐sequencing (n = 357) and microarray (n = 360). Patterns of interactions between and among these perturbed pathways were evaluated using a knowledge network (KN). Results Across the PIA, nine perturbed pathways (FDR

Abstract Oncology patients experience numerous co-occurring symptoms during their treatment. The identification of sentinel/core symptoms is a vital prerequisite for therapeutic interventions. In this study, using Network Analysis, we investigated the inter-relationships among 38 common symptoms over time (i.e., a total of six time points over two cycles of chemotherapy) in 987 oncology patients with four different types of cancer (i.e., breast, gastrointestinal, gynaecological, and lung). In addition, we evaluated the associations between and among symptoms and symptoms clusters and examined the strength of these interactions over time. Eight unique symptom clusters were identified within the networks. Findings from this research suggest that changes occur in the relationships and interconnections between and among co-occurring symptoms and symptoms clusters that depend on the time point in the chemotherapy cycle and the type of cancer. The evaluation of the centrality measures provides new insights into the relative importance of individual symptoms within various networks that can be considered as potential targets for symptom management interventions.

A major barrier to the analysis of genotyping and sequencing data is the relative complexity of the tools needed to perform the analysis. We developed shinyGAStool, an open source tool that enables the user to perform a candidate gene association analysis from large datasets in an easy to use tool from a web browser. With a 3-step workflow, shinyGAStool allows the user to (1) identify and explore distributions of the phenotype and covariates, (2) select genes and variants to evaluate, and (3) run an association analysis linking the two.

Abstract Aim Evaluate for differences in demographic and clinical characteristics and subjective and objective measures of cognitive function (CF) between younger older adults (YOA, 60–69 years) and older adults (OA, ≥70 years). Design Cross‐sectional. Methods Older oncology patients (n = 139) completed subjective (Attentional Function Index, European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC) CF scale) and objective (Montreal Cognitive Assessment, Trail Making Test (TMT) A & B) measures of CF prior to chemotherapy. Data were analyzed using parametric and nonparametric tests. Results No differences were found between the two groups for any of the subjective or objective CF measures, except that OA patients had higher TMT B scores. Compared with the general population, OAs had significantly higher EORTC CF scores and YOAs had significantly worse scores for all of the objective tests. Clinically meaningful difference between group differences was found for the TMT B test.

Abstract Purpose To identify subgroups of female breast cancer patients with distinct self-reported employment interference (EI) profiles and determine which demographic, clinical, and symptom characteristics, and quality of life outcomes were associated with subgroup membership. Methods Women with breast cancer (n = 385) were assessed for changes in EI over ten times, from prior to, through 12 months after breast cancer surgery. Latent profile analysis (LPA) was used to identify subgroups of patients with distinct EI profiles. Results Three distinct EI profiles (i.e., None – 26.2% (n = 101), Low – 42.6% (n = 164), High – 31.2% (n = 120)) were identified. Compared to the None and Low groups, patients in the High group were more likely to be younger. Higher proportions in the High group were non-White, pre-menopausal prior to surgery, had more advanced stage disease, had received an axillary lymph node dissection, had received neoadjuvant chemotherapy, had received adjuvant chemotherapy, and had a re-excision or mastectomy on the affected breast within 6 months after surgery. In addition, these patients had lower quality of life scores. Compared to the None group, the High group had higher levels of trait and state anxiety, depressive symptoms, fatigue and sleep disturbance and lower levels of cognitive function. Conclusions This study provides new knowledge regarding EI profiles among women in the year following breast cancer surgery. The non-modifiable risk factors (e.g., younger age, being non-White, having more advanced stage disease) can inform current screening procedures. The potentially modifiable risk factors can be used to develop interventions to improve employment outcomes of breast cancer patients.

Background: Fatigue and lymphatic pain are the most common and debilitating long-term adverse effects of breast cancer treatment. Fatigue and pain independently have negative effects on quality of life, physical functions, and cancer recurrence-free survival. The interactions between fatigue and pain may aggravate their negative effects. Objectives: Examine the effects of co-occurring fatigue and lymphatic pain on activities of daily living (ADLs), emotional distress, and overall health of breast cancer patients. Methods: A cross-sectional and observational design was used to enroll 354 breast cancer patients. Valid and reliable instruments were used to assess fatigue, lymphatic pain, ADLs, emotional distress, and overall health. Descriptive statistics and multivariable regression models were used for data analysis. Results: After controlling for demographic and clinical factors, patients with co-occurring fatigue and lymphatic pain had higher odds of having impaired ADLs (OR = 24.43, CI = [5.44-109.67], P

Because extracellular vesicle (EV)-associated cytokines, both encapsulated and surface bound, have been associated with symptom severity, and may vary over the lifespan, they may be potential biomarkers to uncover underlying mechanisms of various conditions. This study evaluated the associations of soluble and EV-associated cytokine concentrations with distinct symptom profiles reported by 290 women with breast cancer prior to surgery. Patients were classified into older (≥60 years, n = 93) and younger (< 60 years, n = 197) cohorts within two previously identified distinct symptom severity profiles, that included pain, depressive symptoms, sleep disturbance, and fatigue (i.e., High Fatigue Low Pain and All Low). EVs were extracted using ExoQuick. Cytokine concentrations were determined using Luminex multiplex assay. Mann Whitney U test evaluated the differences in EV and soluble cytokine levels between symptom classes and between and within the older and younger cohorts adjusting for Karnofsky Performance Status (KPS) score, body mass index (BMI), and stage of disease. Partial correlation analyses were run between symptom severity scores and cytokine concentrations. Results of this study suggest that levels of cytokine concentrations differ between EV and soluble fractions. Several EV and soluble pro-inflammatory cytokines had positive associations with depressive symptoms and fatigue within both age cohorts and symptom profiles. In addition, in the older cohort with High Fatigue Low Pain symptom profile, EV GM-CSF concentrations were higher compared to the All Low symptom profile (p < 0.05). Albeit limited by a small sample size, these exploratory analyses provide new information on the association between cytokines and symptom profiles of older and younger cohorts. Of note, unique EV-associated cytokines were found in older patients and in specific symptom classes. These results suggest that EVs may be potential biomarker discovery tools. Understanding the mechanisms that underlie distinct symptom class profiles categorized by age may inform intervention trials and offer precision medicine approaches.

BackgroundWe conducted a pilot 2-arm randomized controlled trial to assess the feasibility of a digital health intervention to increase moderate-to-vigorous physical activity in patients with colorectal cancer (CRC) during chemotherapy. ObjectiveThis study aimed to determine whether a digital health physical activity intervention is feasible and acceptable during chemotherapy for CRC. MethodsPotentially eligible patients with CRC expected to receive at least 12 weeks of chemotherapy were identified in person at the University of California, San Francisco, and on the web through advertising. Eligible patients were randomized 1:1 to a 12-week intervention (Fitbit Flex, automated SMS text messages) versus usual care. At 0 and 12 weeks, patients wore an Actigraph GT3X+ accelerometer for 7 days and completed surveys, body size measurements, and an optional 6-minute walk test. Participants could not be masked to their intervention arm, but people assessing the body size and 6-minute walk test outcomes were masked. The primary outcomes were adherence (eg, Fitbit wear and text response rate) and self-assessed acceptability of the intervention. The intervention would be considered feasible if we observed at least 80% complete follow-up and 70% adherence and satisfaction, a priori. ResultsFrom 2018 to 2020, we screened 240 patients; 53.3% (128/240) of patients were ineligible and 26.7% (64/240) declined to participate. A total of 44 patients (44/240, 18%) were randomized to the intervention (n=22) or control (n=22) groups. Of these, 57% (25/44) were women; 68% (30/44) identified as White and 25% (11/44) identified as Asian American or Pacific Islander; and 77% (34/44) had a 4-year college degree. The median age at enrollment was 54 years (IQR 45-62 years). Follow-up at 12 weeks was 91% (40/44) complete. In the intervention arm, patients wore Fitbit devices on a median of 67 out of 84 (80%) study days and responded to a median of 17 out of 27 (63%) questions sent via SMS text message. Among 19 out of 22 (86%) intervention patients who completed the feedback survey, 89% (17/19) were satisfied with the Fitbit device; 63% (12/19) were satisfied with the SMS text messages; 68% (13/19) said the SMS text messages motivated them to exercise; 74% (14/19) said the frequency of SMS text messages (1-3 days) was ideal; and 79% (15/19) said that receiving SMS text messages in the morning and evening was ideal. ConclusionsThis pilot study demonstrated that many people receiving chemotherapy for CRC are interested in participating in digital health physical activity interventions. Fitbit adherence was high; however, participants indicated a desire for more tailored SMS text message content. Studies with more socioeconomically diverse patients with CRC are required. Trial RegistrationClinicalTrials.gov NCT03524716; https://clinicaltrials.gov/ct2/show/NCT03524716

Abstract Background Respiratory rate (RR) is one of the most important indicators of a patient's health. In critically ill patients, unrecognized changes in RR are associated with poorer outcomes. Visual assessment (VA), impedance pneumography (IP), and electrocardiographic‐derived respiration (EDR) are the three most commonly used methods to assess RR. While VA and IP are widely used in hospitals, the EDR method has not been validated for use in hospitalized patients. Additionally, little is known about their accuracy compared with one another. The purpose of this systematic review was to compare the accuracy, strengths, and limitations of VA of RR to two methods that use physiologic data, namely IP and EDR. Methods A systematic review of the literature was undertaken using prespecified inclusion and exclusion criteria. Each of the studies was evaluated using standardized criteria. Results Full manuscripts for 23 studies were reviewed, and four studies were included in this review. Three studies compared VA to IP and one study compared VA to EDR. In terms of accuracy, when Bland–Altman analyses were performed, the upper and lower levels of agreement were extremely poor for both the VA and IP and VA and EDR comparisons. Conclusion Given the paucity of research and the fact that no studies have compared all three methods, no definitive conclusions can be drawn about the accuracy of these three methods. The clinical importance of accurate assessment of RR warrants new research with rigorous designs to determine the accuracy, and clinically meaningful levels of agreement of these methods.

Background: The-Optimal-Lymph-Flow (TOLF) intervention aims to promote lymph flow through therapeutic lymphatic exercises to relieve lymphatic pain, swelling, lymphedema symptoms, and to decrease lymph fluid levels among breast cancer survivors. To enhance the efficacy of the TOLF intervention, an innovative, intelligent, Kinect-enhanced lymphatic exercise intervention (Kinect-TOLF) was developed to teach patients to perform the lymphatic exercises correctly. Objectives: This feasibility trial aimed to determine the feasibility, usability, and effects of the Kinect-TOLF on lymphatic pain, swelling, lymphedema symptoms, and lymph fluid levels. Methods: A single-arm feasibility trial with a pre- and post-test design was employed to recruit 30 breast cancer survivors with persistent lymphatic pain or swelling. Patients received a single training session to learn how to perform the lymphatic exercises using the Kinect-TOLF program. Descriptive statistics, Wilcoxon signed-rank tests, t -test, Spearman’s rank correlation coefficients, linear regressions, and Cohen’s d were performed for data analysis. Qualitative data were assessed for common themes. Results: The Kinect-TOLF was effective in training patients to perform the lymphatic exercises correctly with high user satisfaction. Significant reductions were found in scores of lymphatic pain ( Med Δ = −1.00, CI = [−1.5, −0.1], P = .004), arm/hand swelling ( Med Δ = −1.00, CI = [−1.5, −0.5], P = .004), total swelling ( Med Δ = −1.5, CI = [−2.0, −1.0], P = .003), number of lymphedema symptoms ( M Δ = −3.8, CI = [−5.5, −2.1], P

Abstract Background Over 1.3 million people live with colorectal cancer in the United States. Physical activity is associated with lower risk of colorectal cancer recurrence and mortality. Interventions are needed to increase physical activity in colorectal cancer survivors. Methods We conducted a 2-arm non-blinded pilot randomized controlled trial at the University of California, San Francisco among 42 individuals who had completed curative-intent treatment for colorectal cancer to determine the feasibility and acceptability of a 12-week (84 days) physical activity intervention using a Fitbit Flex™ and daily text messages. Participants were randomized 1:1 to receive the intervention with print educational materials or print educational materials alone. We explored the impact of the intervention versus usual care on physical activity using ActiGraph GT3X+ accelerometers pre−/post-intervention. Results We screened 406 individuals and randomized 42 to intervention (n = 21) or control (n = 21) groups. During the 12-week study, the intervention arm wore their Fitbits a median of 74 days [88% of days in study period, interquartile range: 23–83 days] and responded to a median of 34 (out of 46) text messages that asked for a reply (interquartile range: 13–38 text messages). Among the 16 intervention participants who completed the feedback survey, the majority (88%) reported that the intervention motivated them to exercise and that they were satisfied with their experience. No statistically significant difference in change in moderate-to-vigorous physical activity was found from baseline to 12 weeks between arms. Conclusion A 12-week physical activity intervention with a Fitbit and text messages was feasible and acceptable among colorectal cancer patients after curative treatment. Larger studies are needed to determine whether the intervention increases physical activity. Trial registration Clinicaltrials.gov Identifier NCT02966054. Registered 17 November 2016, retrospectively registered.

Abstract Background Pain is one of cancer patients’ most frequent and distressing symptoms; however, analgesics’ side effects often increase symptom burden. Further, with the home rapidly becoming the primary cancer care setting, family caregivers (FCs) commonly play central roles in patients’ pain self-management, but with little or no preparation. One US-tested intervention, the PRO-SELF© Plus Pain Control Program (PCP), designed to support cancer outpatients and their FCs in pain self-management, is currently being tested in the Swiss multi-centre PEINCA study. The current PEINCA-FAM study is a sub-study of PEINCA. The aims of PEINCA-FAM are: a) to test the efficacy of the adapted German PRO-SELF © Plus PCP to reduce side effects of analgesics; b) to enhance patients’/FCs’ knowledge regarding cancer pain; and c) to explore FCs’ involvement in patients’ pain self-management. Methods This mixed methods project combines a multi-centre randomized controlled clinical trial with qualitative data collection techniques and includes 210 patients recruited from three oncology outpatient clinics. FCs involved in patients’ pain self-management are also invited to participate. After baseline evaluation, eligible participants are randomized to a 6-week intervention group and a control group. Both groups complete a daily pain and symptom diary. Intervention group patients/FCs receive the weekly psychoeducational PRO-SELF© Plus PCP interventions; control group patients receive usual care. After completing the six-week study procedures, a subsample of 7–10 patients/FCs per group and hospital (N = 42–60) will be interviewed regarding their pain management experiences. Data collection will take place from April 2016 until December 2018. An intent-to-treat analysis and generalized linear mixed models will be applied. Qualitative data will be analysed by using interpretive description. Quantitative and qualitative results will be combined within a mixed method matrix. Discussion In clinical practice, specially trained oncology nurses in outpatient clinics could apply the intervention to reduce side effects and to enhance patients’/FCs’ self-efficacy and pain management knowledge. Trial registration The PEINCA study is registered in the Clinical Trials.gov site (code: NCT02713919, 08 March 2016).

Purpose Ongoing symptoms and impairments in quality of life (QOL) among breast cancer survivors remain a significant problem. We tested the feasibility and acceptability of a manualized Ayurvedic nutrition and lifestyle intervention for breast cancer survivors. Methods Eligible participants had Stage I–III breast cancer, underwent treatment within the past year that included chemotherapy, and were without active disease. The 4-month individualized Ayurvedic intervention included counseling on nutrition, lifestyle, yoga, and marma (like acupressure) during 8 one-on-one visits with an Ayurvedic practitioner. Feasibility and acceptability were the primary outcomes. QOL (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire [EORTC QLQ C30]) and symptoms—sleep disturbance (General Sleep Disturbance Scale [GSDS]), fatigue (Lee Fatigue Scale [LFS]), depressive symptoms (Center for Epidemiological Studies—Depression Scale [CES-D]), anxiety (Spielberger State-Trait Anxiety Inventory [STAI-S, STAI-T]), and stress (Perceived Stress Scale [PSS])—were measured prior to, at midpoint, and at the end of the 4-month intervention. Effect sizes (Cohen’s d ) were calculated along with paired t tests comparing baseline to end of month 4 time points. Mixed effects models were used for repeated measures analyses. Results Participants ( n = 32) had a mean age of 48 years ( SD = 10). Retention at the end of the intervention was 84%. Among those who completed the intervention ( n = 27), adherence was high (99.5% of visits with practitioners attended). Large improvements were seen in QLQ-C30 emotional functioning ( d = 0.84, P

Abstract Background Obesity is linked to poor disease outcomes in breast cancer patients. However, this link was mostly based on body weight or BMI rather than body-fat. The purpose of this study was to evaluate the relationship between body-fat gain and disease progression in Taiwanese women after breast cancer surgery and how this relationship is influenced by menopausal status. Methods Body fat percentage was measured 1 day before and 6 months after surgery in 131 women with stages 0–III breast cancer. Disease outcomes (metastasis and death) were assessed by chart review and telephone contact 7 to 8 years after diagnosis. These data were analyzed by multivariate Cox proportional hazard model analysis. Results The percentage of women with over 5% gain in body-fat was 56% for premenopausal and 42% for postmenopausal. Rates of distant metastasis and all-cause mortality were 17.6 and 9.9%, respectively over the follow-up period. Distant metastases were predicted in postmenopausal but not premenopausal women with breast cancer by increased body fat percentage (HR = 1.3, p = 0.035), after controlling other potential covariates, including disease severity, estrogen receptor expression, progesterone receptors expression, age, and exercise habit before diagnosis. Survival was not significantly associated with body-fat percentage gains. Conclusions Our results suggest that increased body fat percentage 6 months after breast surgery is an important predictor of distant metastasis in postmenopausal Taiwanese women with breast cancer. Clinicians may need to measure patients’ body fat periodically. Our findings should be validated in studies with a longer follow-up time.

Background and purpose — Functional limitations after total knee arthroplasty (TKA) are common. In this longitudinal study, we wanted to identify subgroups of patients with distinct trajectories of pain-related interference with walking during the first year after TKA and to determine which demographic, clinical, symptom-related, and psychological characteristics were associated with being part of this subgroup. Patients and methods — Patients scheduled for primary TKA for osteoarthritis (n = 202) completed questionnaires that evaluated perception of pain, fatigue, anxiety, depression, and illness on the day before surgery. Clinical characteristics were obtained from the medical records. Interference of pain with walking was assessed preoperatively, on postoperative day 4, and at 6 weeks, 3 months, and 12 months after TKA. Results — Using growth mixture modeling, 2 subgroups of patients were identified with distinct trajectories of pain-related interference with walking over time. Patients in the Continuous Improvement class (n = 157, 78%) had lower preoperative interference scores and reported a gradual decline in pain-related interference with walking over the first 12 months after TKA. Patients in the Recurrent Interference class (n = 45, 22%) reported a high degree of preoperative pain-related interference with walking, initial improvement during the first 3 months after TKA, and then a gradual increase—returning to preoperative levels at 12 months. Patients in the Recurrent Interference class had higher preoperative pain, fatigue, and depression scores, and poorer perception of illness than the Continuous Improvement class. Interpretation — 1 in 5 patients did not improve in pain-related interference with walking at 12 months after TKA. Future studies should test the efficacy of interventions designed to modify preoperative characteristics.

Background: Anal squamous intraepithelial lesions (SIL) and cancers are increased in immunocompromised populations. Based upon anatomic and histologic similarities, the cervix is used as the model for anal screening. During cervical colposcopy, acetic acid (AA) and Lugol׳s staining (LS) result in characteristic changes that help distinguish low-grade (L)SIL from high-grade (H)SIL. Lesion characteristics were evaluated for their ability to distinguish anal (a)LSIL from anal (a)HSIL during high-resolution anoscopy after application of AA and LS. Methods: AA-stained lesions were described using standard cervical colposcopic criteria. LS was then applied and lesions were characterized as Lugol׳s-negative (L−), Lugol׳s-partial (L+/−), or Lugol׳s positive (L+) and then biopsied. Biopsies were characterized as benign, squamous atypia, LSIL or HSIL. Results: 835 anal lesions were analyzed. Sensitivity and positive predictive value (PPV) for aHSIL were highest for characteristics associated with cervical (c)HSIL. L− was independently associated with aHSIL (OR=4.7, 95% CI=3.4–6.7). In multiple logistic regression analysis, significant predictors of aHSIL were flat contour (OR=2.24, 95% CI=1.3–3.8), mosaic pattern (OR=2.0, 95% CI=1.4–2.9), vascular punctation (OR=1.5, 95% CI=1.1–2.1) and L− (OR=2.3, 95% CI=1.5–3.4). L− staining improved the PPV of aHSIL almost twofold in lesions that otherwise had a colposcopic impression of LSIL. Conclusions: Evaluating acetowhite lesions for contour, surface, vascularity, and LS may maximize the likelihood of identifying aHSIL. Keywords: Anal, HSIL, High resolution anoscopy, Lugol׳s staining

Effective symptom management is a critical component of cancer treatment. Computational tools that predict the course and severity of these symptoms have the potential to assist oncology clinicians to personalize the patient's treatment regimen more efficiently and provide more aggressive and timely interventions. Three common and inter-related symptoms in cancer patients are depression, anxiety, and sleep disturbance. In this paper, we elaborate on the efficiency of Support Vector Regression (SVR) and Non-linear Canonical Correlation Analysis by Neural Networks (n-CCA) to predict the severity of the aforementioned symptoms between two different time points during a cycle of chemotherapy (CTX). Our results demonstrate that these two methods produced equivalent results for all three symptoms. These types of predictive models can be used to identify high risk patients, educate patients about their symptom experience, and improve the timing of pre-emptive and personalized symptom management interventions.

OBJECTIVES:Unrelieved postoperative pain after total knee arthroplasty (TKA) is a significant problem. This longitudinal study investigated how preoperative pain intensity, as well as a comprehensive list of preoperative and perioperative factors, influenced the severity of acute average and worst pain after TKA. METHODS:Prior to surgery, 203 patients completed a demographic questionnaire, Lee Fatigue Scale, Fatigue Severity Scale, Hospital Anxiety and Depression Scale, and Brief Illness Perception Questionnaire. Brief Pain Inventory was completed prior to surgery as well as through postoperative days (POD) 0 to 4. Clinical data were extracted from medical records. RESULTS:Several factors were associated with higher levels of preoperative and postoperative pain. Lower preoperative average and worst pain intensity scores were associated with increases in average and worst postoperative pain from POD1 to POD4. A higher number of comorbidities, higher C-reactive protein values, and higher pain interference with function were associated with higher preoperative levels of average pain. Older age, higher fatigue levels, and higher scores on identity and emotional responses to osteoarthritis (OA) were associated with higher preoperative levels of worst pain. Lower perceived consequences of OA were associated with higher pain from POD1 to POD4. Males and patients with lower preoperative scores for average pain had higher worst pain following surgery. DISCUSSION:Patients at higher risk for more severe postoperative pain can be identified through an assessment of pain and other risk factors identified in this study. Future research needs to test the efficacy of interventions that modify patients' perceptions of living with OA and pain intensity before surgery on short and long term postoperative outcomes.

Background: In recent years, the shift in cancer services from traditional tertiary care to care delivered within communities has increased the need for patients to engage in self-care activities in order to prevent or reduce the severity of numerous and complex-side effects (McCorkle et al., 2011) and make important health decisions when at home in the absence of clinicians (Butow et al., 2012). The actual degree of engagement in self-management may be dependent on patients’ perceived competence or self-efficacy to perform such activities (Fenlon et al., 2015). Self-efficacy has been defined as “a person’s belief to execute courses of action required to deal with a prospective situation” (Bandura, 1977, 2001). One’s beliefs in their capability to successfully manage tasks and consequently influence situations that impact their lives constitutes a central part of human agency, and can be influenced by performance accomplishments (Bandura, 1989, 2001). Whilst self-efficacy can enable engagement in self-management, actual participation in self-management activities can further increase one’s perceived ability to undertake such activities; it is thus obvious that a bi-directional association between self-management and self-efficacy exists. Supporting a shift in clinical practice with innovative technological systems affords a solution to the increasing demands placed on acute care by enabling the delivery of care in the home and community setting (Basch et al., 2011; Carpenter et al., 2008). Such remote monitoring systems facilitate the provision of clear lines of real-time communication between patients and their health care providers (Basch et al., 2011), and can deliver organised self-management advice tailored to the individual’s clinical characteristics and severity/distress of symptoms of anti-cancer treatment. Aim(s): Funded by the European Union (FP7 programme), a multi-centre European project (the eSMART study) has been designed to investigate the effects of an electronic patient-reported outcomes (ePRO) system, the Advanced Symptom Management System (ASyMS), on patient outcomes including improvement in self-efficacy, symptom management, supportive care needs, psychological status, work presenteeism, and well-being; health system costs; and the current clinical practice. The primary aim of eSMART is to evaluate the short and long term impact of the ASyMS technology on patient reported outcomes in people with breast cancer, colorectal cancer or haematological malignancies receiving first-line chemotherapy. In addition, eSMART will evaluate the cost-benefit of remote patient-monitoring and changes in clinical practice as a result of the application of the ASyMS intervention in different European healthcare settings. The study is currently recruiting patients, thus no data will be available for presentation. This presentation will nonetheless aim to present and discuss the hypothesis that provision of symptom self-management advice may be an important mechanism to improve patient self-efficacy, which may establish a self-sustained cycle where self-care advice provision enables patient self-efficacy and this in turn further increases patient involvement in self-management that can ultimately lead to improved patient outcomes. Method(s)/Results: The current study has been informed by the Medical Research Council Complex Interventions Framework (Anderson, 2008; Craig and Petticrew, 2012; Mackenzie et al., 2010), and the Holistic Framework to improve the Uptake and Impact of e-Health Technologies (van Gemert-Pijnen et al., 2011). The eSMART programme of work comprises two parts that will take place over a period of five years. The first part consists of preparatory work to refine the ASyMS intervention for use in a multi-national context, and concludes with a feasibility testing period to establish the technological readiness of the system prior to its use in the second part. The second part will employ a repeated-measures, parallel-group, stratified randomised controlled trial methodology to demonstrate the effects of the ASyMS intervention in supporting patients who receive chemotherapy treatment through individualised symptom management. The second part will test the short- (i.e. during the treatment phase) and long-term effects (i.e. at one-year follow-up) of the ASyMS intervention versus standard care across the participating countries (Austria, Greece, Ireland, Norway and the UK). The ASyMS intervention comprises use of a mobile phone (i.e. ASyMS patient handset) and a tympanic thermometer. The patient handset will enable participants on the intervention group to enter symptom/temperature data on a dedicated, electronic symptom questionnaire daily and whenever they feel unwell. Upon successful submission of their data, patients will immediately receive automated, evidence-based self-care advice based on their symptom reports. Patients will also have access to a self-care library, symptom graphs (detailing trends in individual symptoms experienced) and contact numbers of care teams and patient support organisations in their country, available within the ASyMS patient handset. Via dedicated tablet PCs, all participants will complete an electronic version of the Communication and Attitudinal Self-Efficacy scale for cancer (CASE-Cancer) (Wolf et al., 2005) at baseline; after each CTx; and 3, 6, 9 and 12 months post-chemotherapy treatment. The CASE-Cancer is a validated, 12-item measure that yields scores on three factors: understanding and participating in care, maintaining a positive attitude, and seeking and obtaining information. In accordance with latest recommendations for pragmatic research in healthcare (Oakley et al., 2006; Treweek and Zwarenstein, 2009), the longitudinal nature of the trial will aid to establish sustainability of intervention effects and further stress its benefits when compared to standard care. Conclusions: This anticipatory model of care supports symptom management within the patient’s home, where the early toxicities of chemotherapy can be managed, utilising self-care and local community services. This model is also expected to contribute to the health literacy of patients with cancer in relation to early identification, report and self-management of their most common symptoms. As part of the project’s objectives, we will aim to show improved self-efficacy (as shown by statistically significantly higher self-efficacy scores) during active chemotherapy for breast cancer, colorectal cancer, or haematological malignancies, and/or at one-year follow-up. It is hoped that an enhanced self-efficacy (evidenced by patients’ greater understanding and participation in care, positive attitude, and engagement in seeking health-related information) will in turn enable a smoother rehabilitation process for patients in the post-treatment survivorship period and beyond. EU FP7 Programme Grant agreement No. 602289. Trial registration identifier (clinicaltrials.gov) NCT02356081.

The purposes of this study were to evaluate for differences in phenotypic and genotypic characteristics in women who did and did not develop lymphedema (LE) following breast cancer treatment. Breast cancer patients completed a number of self-report questionnaires. LE was evaluated using bioimpedance spectroscopy. Genotyping was done using a custom genotyping array. No differences were found between patients with (n = 155) and without LE (n = 387) for the majority of the demographic and clinical characteristics. Patients with LE had a significantly higher body mass index, more advanced disease and a higher number of lymph nodes removed. Genetic associations were identified for four genes (i.e., lymphocyte cytosolic protein 2 (rs315721), neuropilin-2 (rs849530), protein tyrosine kinase (rs158689), vascular cell adhesion molecule 1 (rs3176861)) and three haplotypes (i.e., Forkhead box protein C2 (haplotype A03), neuropilin-2 (haplotype F03), vascular endothelial growth factor-C (haplotype B03)) involved in lymphangiogensis and angiogenesis. These genetic associations suggest a role for a number of lymphatic and angiogenic genes in the development of LE following breast cancer treatment.

The purposes of this study were to identify distinct latent classes of individuals based on subjective reports of sleep disturbance; to examine differences in demographic, clinical, and symptom characteristics between the latent classes; and to evaluate for variations in pro- and anti-inflammatory cytokine genes between the latent classes. Among 167 oncology outpatients with breast, prostate, lung, or brain cancer and 85 of their FCs, growth mixture modeling (GMM) was used to identify latent classes of individuals based on General Sleep Disturbance Scale (GSDS) obtained prior to, during, and for four months following completion of radiation therapy. Single nucleotide polymorphisms (SNPs) and haplotypes in candidate cytokine genes were interrogated for differences between the two latent classes. Multiple logistic regression was used to assess the effect of phenotypic and genotypic characteristics on GSDS group membership. Two latent classes were identified: lower sleep disturbance (88.5%) and higher sleep disturbance (11.5%). Participants who were younger and had a lower Karnofsky Performance status score were more likely to be in the higher sleep disturbance class. Variation in two cytokine genes (i.e., IL6, NFKB) predicted latent class membership. Evidence was found for latent classes with distinct sleep disturbance trajectories. Unique genetic markers in cytokine genes may partially explain the interindividual heterogeneity characterizing these trajectories.