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Background: Women with breast cancer account for the largest cohort (23%) of over 18 million cancer survivors in the United States. Of the nearly 4 million breast cancer survivors, many, including individuals with metastatic breast cancer, will require lifelong treatment for chronic conditions. As part of a multi-site study including diverse tumor types, breast cancer survivors are being recruited to explore the feasibility and outcomes of a digital health coaching (DHC) program following the completion of primary therapy to support self-management of symptoms and general wellness. Trial design: A randomized-wait list control design will evaluate outcomes related to engagement in a DHC program following completion of primary therapy. Participants will be enrolled in a 6-month DHC program delivering evidence-based content via weekly calls, text, and email, in addition to usual support from their respective healthcare teams. The intervention group will receive coaching upon enrollment. The control group will receive coaching after a 6-month monitoring period. Twelve months of longitudinal clinical, patient-reported outcomes, activity tracking (via Fitbit), and microbiome data will be collected from both groups. Eligibility criteria: The breast cancer cohort will consist of individuals with both localized and metastatic disease within 1 year of completion of primary therapy, defined as treatment of curative intent, first-line or later, from which the individual is advancing to active surveillance or follow-up, with or without maintenance therapy. All study participants must be >18 years old, able to read and speak English, have access to mobile technology, and agree to wear and have data collected from an activity tracker. Specific aims: 1) Assess the feasibility and acceptability of a DHC program and its effect on participant health self-efficacy; 2) characterize associations between participant symptoms, physical/psychosocial well-being, and health self-management and gut microbiota changes; and 3) explore patient-generated health data outcomes among participants (patient reported and wearable biometrics outcomes). Statistical methods: Feasibility and acceptability will be assessed through descriptive statistics. Feasibility for this study is defined as a retention rate ≥70%, and acceptability is defined as ≤20% scoring “not at all helpful.” Secondary aims will be assessed using linear mixed models. Cross-cohort analysis of physical function, measured by the PROMIS Physical Function 10a, will be conducted. Assuming a power of 0.8 and significance level of .05, we will be able to detect a 2.51 difference in PROMIS score means between the control and intervention group (SD 10) with a sample of 500 total participants. Sub-group analysis will be conducted with the anticipated 250 participants in the breast cancer cohort with a focus on feasibility, acceptability, and descriptive and exploratory endpoints for this population as a whole and comparing early stage and metastatic participants. Target and present accruals: 500 individuals with diverse tumor types will be enrolled across 5 collaborating sites, of which 4 ill include individuals with breast cancer. An estimated 250 breast cancer participants (approximately 50% of the total study population), including 150 with de novo or progressive metastatic breast cancer, are planned to be recruited. To date, 1 Midwestern site has enrolled the first 7 breast cancer survivors. Two additional sites plan to enroll in July 2022, with the remaining 2 sites to begin enrollment by the end of 2022. Citation Format: Robin M. Lally, Rachael L. Schmidt, Gisele Tlusty, Elizabeth K. Arthur, Laura K. Flora, Jessica L. Krok-Schoen, Jessica T. Jones, Meagan Whisenant, Abbey Kaler, Debu Tripathy, Leorey Saligan, Marilyn Hammer, Austin Barr, Lindsey Jackson, Jennifer Loftis, Kelly J. Brassil. Breast Cancer Cohort of the Comprehensive Outcomes for After Cancer Health (COACH) Study: Study Protocol [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr OT2-06-01.

The role of the nurse scientist in the clinical setting is not well defined, which contributes to variability in role implementation, scope, administration, funding, and affiliation across healthcare sites.The aim of this scoping review was to identify attributes of the clinical nurse scientist role and its operationalization in the clinical setting through available evidence.A comprehensive, computerized search of the literature in PubMed, Medline, and CINAHL was conducted in early May 2020 by a medical research librarian and repeated in July 2021 and April 2022. The 5-step framework described by Arskey and O'Malley guided the review methodology. Two reviewers conducted an independent screen of all articles, followed by a full-text review of eligible articles by two independent reviewers each using a standardized data extraction template. Themes were then organized and synthesized using descriptive content analysis from the included articles.A final sample of 55 full-text articles were included in the review. Overall, the findings suggest that the nurse scientist role in a clinical setting can be challenging to implement in complex healthcare environments. Successful models include the nurse scientist in a leadership role, alignment of research with institutional priorities, and strong support from senior leadership.Findings suggest that standardized guidelines are lacking to govern the implementation of the nurse scientist role in the clinical setting. To succeed, the nurse scientist role must be valued and supported by organizational leaders. Further, access to resources to build infrastructure must be provided. The magnitude and scope of individual organizational support can be tailored based on the resources of the institution; however, the foundation of having institutional leadership support is critical to role success of the clinical nurse researcher.

Emergency healthcare professionals (EHPs) face significant occupational stressors requiring the skilled use of adaptive coping strategies. Some EHP resort to maladaptive coping (MC) strategies that negatively impact their mental health, yet MC strategies are not clearly defined in the literature. Examining factors that predispose EHP to MC can support interventions to improve coping and well-being.This systematic review examined MC among EHP working in pre-hospital and hospital-based settings. The primary aim was to identify factors associated with MC strategies used by EHP.Embase, Ovid, CINAHL Plus, PsychInfo, and the Cochrane Library were systematically searched for quantitative studies measuring MC use among EHP. Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) 2020 checklist was used to guide the review. Studies were included if they: (a) targeted licensed healthcare professionals providing patient care, (b) occurred in emergency department or pre-hospital emergency setting, and (c) examined provider coping. Studies were excluded if they: (a) did not include EHPs, (b) did not differentiate results in mixed samples, (c) did not clearly measure coping strategies, (d) failed to include MC strategies in the results, or (e) were not available in full text. Risk of bias and study quality was appraised using Joanna Briggs Institute (JBI) Critical Appraisal Checklist. Bandura's Social Cognitive Theory (SCT) guided the final synthesis, drawing conclusions from the evidence to identify factors associated with MC in EHP.A total of 14 cross-sectional studies, published between 2003 and 2021, were included in the review. Included studies were conducted in either pre-hospital, hospital, or a combination of both settings. Most studies included mixed samples or emergency physicians. A variety of coping strategies were significantly correlated with poor mental health outcomes including venting, denial, disengagement, self-blame, and substance use. Among personal factors, EHPs who were female, older than 50, living alone, with personal trauma history were significantly more likely to use MC strategies. Additionally, EHP with children, work experience, higher life satisfaction, and resilience were negatively associated with MC. Environmental factors positively associated with MC included work stress, workload, and poor benefits. Trauma exposure had a positive, but non-significant relationship.Emergency healthcare professionals use a variety of coping strategies, many of which are maladaptive and significantly related to poor mental health outcomes. Several personal and environmental factors contribute to behavior that reflect the use of MC strategies, but findings are sparse. Researchers should consider current limitations and challenges, particularly mental health stigma, when designing future studies.The evidence in this review suggests that certain factors predispose EHP for use of MC strategies. This review highlights an important research gap necessitating more robust studies to identify MC risk factors among EHP in chronically high-stress environments.

To analyze the concept of patient voice and discuss implications for clinical care of individuals with metastatic cancer.The diagnosis of metastatic cancer requires increased patient support and healthcare resource utilization. The patient voice should be heard and incorporated into care planning to improve the overall experience of individual with metastatic cancer.Concept analysis.Dictionary definitions and scientific literature from electronic databases, including PubMed.Using Walker and Avant's method of concept analysis, we identified attributes, antecedents, and consequences.Patient voice is defined as verbal or written communication by the patient to their healthcare partner to positively influence their quantity and quality of life. Attributes of patient voice include context, healthcare partner, safety, time, active listening, communication, and incorporation. Antecedents to patient voice include patient, baseline knowledge, continuing education, medical system culture, and emotional intelligence, and consequences include improved quality of life, adherence to treatment plan, overall satisfaction, and sense of control. Every instance of patient voice prepares the individual for future experiences that can positively impact their care.The concept of patient voice is vital to integrate into care to ensure individual's wishes and goals are incorporated in advanced disease populations. Systematically incorporating the patient voice into the care of individuals with metastatic cancer will allow patients to experience treatment and the progression to end-of-life care according to their preferences.

Despite their significant distress, supportive care interventions for caregivers of glioma patients are generally lacking. And, whether caregivers are more likely to benefit from interventions targeting patient-caregiver dyads or caregivers individually is unknown. This pilot randomized controlled trial compared the feasibility and preliminary efficacy of a dyadic yoga (DY) versus an individual caregiver yoga (CY) intervention as a supportive care strategy for family caregivers.Patient-caregiver dyads were randomized to a DY, CY or usual care (UC) arm. DY and CY interventions were delivered over 15 sessions. Caregivers completed assessments of their depressive symptoms, quality of life (QOL), and caregiving reactions at baseline, 6 weeks, and 12 weeks, and a subset completed qualitative interviews at 12 weeks.With a consent rate of 63%, 67 dyads were randomized. Attendance in the DY was higher than in the CY group (session means, DY = 12.23, CY = 9.00; p = 0.06). Caregivers (79% female; 78% non-Hispanic White; mean age, 53 years) reported significantly more subjective benefit in the CY arm than in the DY arm (d = 2.1; p .01), which was consistent with the qualitative assessment. There were medium effect sizes for improved mental QOL (d = 0.46) and financial burden (d = 0.53) in favor of the CY over the UC group. Caregivers in the CY group reported more caregiving esteem (d = 0.56) and less health decline (d = 0.60) than those in the DY group.Individual rather than dyadic delivery may be a superior supportive care approach for this vulnerable caregiver population. A larger, adequately powered efficacy trial is warranted.

Objectives Although patients with primary and metastatic brain tumors and their partners are at risk of experiencing high symptom burden, they are often excluded from psychosocial intervention studies. Thus, we sought to examine the feasibility and preliminary efficacy of a couple-based meditation (CBM) program targeting symptom and well-being outcomes. Methods Couples completed baseline measures assessing symptom and well-being outcomes and were randomized to the CBM or a usual care control group. Couples in the CBM groups attended four weekly (60 minutes each) therapist-led sessions that were delivered via FaceTime (Apple Inc, Cupertino, CA). The CBM program focused on cultivating mindfulness, compassion, gratitude and purpose, and integrated emotional disclosure exercises. Both groups were reassessed six and 12 weeks after baseline. Results We approached 60 eligible dyads, of which 37 (62%) consented, 35 (95%) were randomized, and 22 (63%) completed all assessments. Couples in the CBM group attended a mean of 3.33 sessions (SD 1.09). For patients, significant group differences in favor of the CBM group were found for cognitive (d = 1.05) and general disease symptoms (d = 0.93), and relationship well-being (d = 0.68) and compassion (d = 0.96). No significant group differences were revealed for partners. Conclusion It seems to be feasible, acceptable, and possibly efficacious to deliver a dyadic intervention via FaceTime to brain tumor couples. Although both patients and partners in the CBM group rated the intervention as beneficial, significant group differences with medium-to-large effect sizes were only found for patients.

Background: Inflammatory breast cancer (IBC) is an aggressive, locally advanced breast cancer with a poor prognosis including a median survival of less than 4 years and a 5-year survival rate of around 60-70%. Symptom monitoring and management has demonstrated improved cancer patient outcomes, including quality of life, resource utilization, ability to continue treatment, and disease-free survival. The use of disease-specific patient-reported outcomes (PROs) is critical for facilitating individualized symptom monitoring and management. While women with IBC likely experience significant and variable symptom burden from diagnosis through treatment and survivorship that may remain under-reported and unmanaged, there is limited description of the symptom burden in this population and no disease-specific valid and reliable instrument for measuring symptom burden in IBC. In addition, because the diagnosis of IBC is based on clinical criteria as opposed to molecular or pathological diagnostic criteria, attention to defining the disease-related symptoms may assist clinicians in making timely and accurate diagnoses. The purpose of this study was to describe the patient experience of IBC and define the content domain for a PRO measure of IBC symptom burden, using patient input to ensure content validity. Methods: This descriptive study is the first stage in development of a PRO IBC symptom burden measure. Twenty patients with IBC across the disease continuum described their experience in single qualitative interviews. Content analysis was used to describe their experience and define the symptom burden content domain. Results: Mean patient age was 52.8 years (range, 30-73 years); 50% with locally advanced and 50% with metastatic disease, with 85% receiving treatment at the time of the interview. Content analysis found 51 symptoms related to both disease and treatment, with 24 symptoms reported at least 20% of participants. Participants reported, on average, 13.1 symptoms (range, 3-23 symptoms). All participants described localized disease-related symptoms that were present at diagnosis, which included breast rash (40% of participants), changes in the texture of the breast (55%), nipple changes (25%), breast pain (40%), breast discoloration (70%), breast lump (55%), breast warmth (10%), and breast swelling (50%). Treatment-related symptoms varied among participants based on modalities received. Patients volunteered ways in which symptoms impacted daily activities and relationships and how symptoms were managed. Conclusions: We have completed our pilot study. Patients with IBC experience numerous symptoms related to disease and treatment, including many localized disease-related symptoms with various treatments resulting in unique symptom burden. Symptoms may result in interference with daily activities, relationships, life plans, treatment adherence, and mood. Well-designed PROs are essential for accurate symptom assessment and management to maintain patient functioning. The content domain for a PRO symptom-burden measure of IBC encompasses the severity and activity interference of common symptoms of IBC and its treatment. Citation Format: Meagan Whisenant, Angela Alexander, Loretta A. Williams, Wendy Woodward, Randa El-Zein, Naoto Tada Ueno. Establishing the content domain for a patient-reported outcomes measure to evaluate the unique symptom burden of inflammatory breast cancer [abstract]. In: Proceedings of the 2019 San Antonio Breast Cancer Symposium; 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr P6-15-06.

OBJECTIVE A variety of symptoms may be associated with type 2 diabetes and its complications. Symptoms in chronic diseases may be described in terms of prevalence, severity, and trajectory and often co-occur in groups, known as symptom clusters, which may be representative of a common etiology. The purpose of this study was to characterize type 2 diabetes–related symptoms using a large nationwide electronic health record (EHR) database. Methods We acquired the Cerner Health Facts, a nationwide EHR database. The type 2 diabetes cohort (n = 1,136,301 patients) was identified using a rule-based phenotype method. A multistep procedure was then used to identify type 2 diabetes–related symptoms based on International Classification of Diseases, 9th and 10th revisions, diagnosis codes. Type 2 diabetes–related symptoms and co-occurring symptom clusters, including their temporal patterns, were characterized based the longitudinal EHR data. Results Patients had a mean age of 61.4 years, 51.2% were female, and 70.0% were White. Among 1,136,301 patients, there were 8,008,276 occurrences of 59 symptoms. The most frequently reported symptoms included pain, heartburn, shortness of breath, fatigue, and swelling, which occurred in 21–60% of the patients. We also observed over-represented type 2 diabetes symptoms, including difficulty speaking, feeling confused, trouble remembering, weakness, and drowsiness/sleepiness. Some of these are rare and difficult to detect by traditional patient-reported outcomes studies. Conclusion To the best of our knowledge, this is the first study to use a nationwide EHR database to characterize type 2 diabetes–related symptoms and their temporal patterns. Fifty-nine symptoms, including both over-represented and rare diabetes-related symptoms, were identified.

INTRODUCTION: There is growing recognition that systematically obtaining the patient’s perspective on their health experience, using patient-reported outcomes (PRO), can be used to improve patient care in real time. Few PRO systems are designed to monitor and provide symptom management support between visits. Patients are instructed to contact providers between visits with their concerns, but they rarely do, leaving patients to cope with symptoms alone at home. We developed and tested an automated system, Symptom Care at Home (SCH), to address this gap in tracking and responding to PRO data in-between clinic visits. The purpose of this paper is to describe SCH as an example of a comprehensive PRO system that addresses unmet need for symptom support outside the clinic. METHODS FOR PRO SCORE INTERPRETATION: SCH uses pragmatic, single-item measures for assessing symptoms, which are commonly used and readily interpretable for both patients and providers. We established alerting values for PRO symptom data, which was particularly important for conserving oncology providers’ time in responding to daily PRO data. METHODS FOR DEVELOPING RECOMMENDATIONS FOR ACTING ON PRO RESULTS: The SCH system provides automated, just-in-time self-management coaching tailored to the specific symptom pattern and severity levels reported in the daily call. In addition, the SCH system includes a provider decision support system for follow-up symptom assessment and intervention strategies. DISCUSSION: SCH provides PRO monitoring, tailored automated self-management coaching, and alerts the oncology team of poorly controlled symptoms with a provider dashboard that includes evidence-based decision support for follow-up to improve individual patients’ symptom care. We particularly emphasize our process for PRO selection, rationale for determining alerting thresholds, and the design of the provider dashboard and decision support. Currently, we are in the process of updating the SCH system, developing both web-based and app versions in addition to interactive voice response phone access and integrating the SCH system in the electronic health record.

Background: The use of disease-specific patient-reported outcomes (PROs) is critical for facilitating individualized symptom monitoring and improving cancer patient outcomes. The MD Anderson Symptom Inventory (MDASI) is a PRO measure of symptom burden. The purpose of this study was to describe the patient experience and define the content domain for the MDASI module specific to breast cancer (MDASI-Br). Methods: 36 patients with breast cancer across the disease and treatment continuum described their experience in single qualitative interviews. Content analysis was used to define the symptom burden content domain. An expert panel scored the relevance on a 0–4 scale (4 = relevant) of the symptoms identified from the qualitative interviews. Symptoms were selected for inclusion in the MDASI-Br if they met at least 1 of the following criteria: (1) mean relevance rating of ≥3 by the expert panel, (2) described by ≥20% of patients in qualitative interviews, or (3) core MDASI items. Results: Participants had a mean age of 57.9 years, 86.1% had stage I–III, and 52.8% were on active treatment. 36 symptoms were identified, with 14 reported by ≥20% of participants. Symptoms varied among participants based on disease stage and treatment modality. Fatigue and distress were described by most women regardless of treatment, whereas arm swelling was reported only by women who had undergone surgery, and skin changes were reported primarily by women who received radiation therapy. Patients volunteered ways in which symptoms affected daily functioning. 21 symptoms were included in the MDASI-Br for psychometric testing, including 6 breast cancer-specific symptoms: breast changes, hot flashes, constipation, arm swelling, fingernail or toenail changes, and skin changes. Two additional symptoms, vaginal dryness and decrease in sexual interest or activity, were included because they are common to endocrine therapy. Conclusions: Patients with breast cancer experience numerous but distinct symptoms related to disease and treatment that may result in interference with daily activities, relationships, life plans, treatment adherence, and mood. Various treatments result in unique symptom burden. The content domain for a PRO symptom-burden measure of breast cancer encompasses the diversity, severity, and activity interference of common symptoms of breast cancer and its treatment.

Objectives There is little research on the patient experience of symptom burden from CAR T-cell therapy, and no validated measure specific to the symptoms of CAR T-cell therapy currently exists. The purpose of this study was to identify symptoms experienced and to determine the content domain for a patient-reported outcome (PRO) measuring symptom burden for patients who had received standard of care CAR T-cell therapy for advanced B-cell lymphoid malignancies. Data Sources Semi-structured qualitative interviews were conducted with a sample of 21 patients who had received CAR T-cell therapy. Content analysis was used to define the symptom burden content domain. Conclusion Sixty-two percent of patients were interviewed within 3 months of therapy; 81.0% experienced cytokine release syndrome and 28.6% experienced neurotoxicity. Content analysis found 31 symptoms related to disease and treatment. The most common disease-related symptom identified by patients was pain (43%). The most common symptoms identified by patients as related to CAR T-cell therapy included fatigue (tiredness) (62%), lack of appetite (29%), headache (29%), chills or feeling cold (24%), and feeling confused (24%). The qualitative analysis also confirmed that symptoms interfere with daily activities, work, walking, relationships with others, mood, and enjoyment of life. Implications for Nursing Practice Patients who receive standard CAR T-cell therapy experience numerous symptoms related to disease and CAR T-cell therapy, including symptoms related to the T-cell infusion. Symptoms may result in interference with daily activities, relationships, treatment adherence, and mood. Oncology nurses should be aware of and assess symptom related to CAR T-cell therapy.

Background The complexity of disease- and treatment-related symptoms causes profound distress and deterioration of health-related quality of life among patients with brain tumors. Currently, there is no Danish validated disease-specific instrument that focuses solely on measures of both neurologic and cancer-related symptoms of patients with brain tumors. The MD Anderson Symptom Inventory Brain Tumor Module (MDASI-BT) is a validated patient self-report questionnaire that measures symptom prevalence, intensity, and interference with daily life. The aim of the present study was to determine the psychometric validity of the Danish translation of the MDASI-BT, and to test its utility in 3 cohorts of Danish patients across the spectrum of the brain cancer disease and treatment trajectory. Methods A linguistic validation process was conducted. Danish patients with malignant primary brain tumors were included to establish the psychometric validity and reliability of the Danish MDASI-BT. Cognitive debriefing interviews were conducted to support the psychometric properties. Results A total of 120 patients participated in this study. Coefficient αs for the symptom and interference subscales indicate a high level of reliability across all items. Corresponding symptom and interference or functional items and subscales in the MDASI-BT and European Organisation for Research and Treatment of Cancer Brain Tumor Module BN20 were significantly correlated. Cognitive debriefing provided evidence for content validity and questionnaire utility as participants were comfortable answering the questions and had no problem with the understandability or number of questions asked. Conclusion The MDASI-BT is a simple, concise symptom assessment tool useful for assessing the symptom severity and interference of Danish-speaking patients with brain cancer.

PURPOSE: Symptom monitoring has demonstrated improved outcomes in patients with cancer, including quality of life, resource utilization, ability to continue treatment, and survival. The use of disease-specific patient-reported outcome (PRO) measures facilitates symptom monitoring. While the MD Anderson Symptom Inventory–Lung Cancer (MDASI-LC), a PRO measure of symptom burden in lung cancer, is psychometrically validated for use in patients with NSCLC, its content validity has not been verified through direct patient input. Our purpose is to describe the symptom experience of patients with NSCLC and to confirm that the MDASI-LC contains the key symptoms specific to NSCLC from the patient perspective. METHODS: Patients with NSCLC described their symptom experience in single qualitative interviews. Content analysis was used to define the content domain for a PRO measure of NSCLC symptom burden. RESULTS: Participants (N = 40) had a mean age of 66.1 years (standard deviation, 10.9 years); 60.0% were male, 77.5% were White, and 56.4% had stage IV disease. Thirty-two symptoms were described, with 6 reported by ≥ 20% of participants. Symptom variations were noted by treatment modality but not by stage of disease. Patients with NSCLC commonly reported shortness of breath, cough, distress, fatigue, pain, and constipation. In patients receiving chemotherapy, treatment-related symptoms, including neuropathy and sore mouth, were commonly noted. The presence of these symptoms resulted in interference with daily activities, relationships, life plans, treatment adherence, and mood. CONCLUSION: The symptoms included in the MDASI-LC are important components of the content domain of an NSCLC symptom burden measure. The presence of these symptoms affect daily life and, therefore, is of clinical consequence.

BACKGROUND Women are at risk of mood disturbance during treatment for breast cancer. OBJECTIVE The aims of this study were to identify classes of women experiencing similar trajectories of depressed mood and anxiety while receiving chemotherapy for breast cancer and to determine associated antecedents and outcomes. The specific aims were to (1) determine the distinct trajectory classes associated with severity of depressed mood and anxiety reported by women undergoing cycles 2 and 3 of chemotherapy for breast cancer, (2) determine if class membership is associated with various antecedent variables, and (3) determine if class membership is associated with days of missed work and hours spent lying down. METHODS In a secondary analysis, classes were identified using Latent Growth Mixture Modeling. Antecedents and outcomes related to class membership were explored. RESULTS Participants (n = 166; mean age, 53 [SD, 10.8] years) were mostly white (91.46%); half had early-stage disease. Two trajectories of depressed mood and anxiety were identified. Receipt of doxorubicin was associated with the higher severity class for depressed mood (P < .01) and anxiety (P = .04). No college education (P = .03) or spending more hours lying down (P = .03) was associated with the higher severity class for anxiety. CONCLUSIONS Distinct trajectories of mood disturbance are distinguished by baseline severity. Further study is needed to determine if biologic or genomic factors are associated with class membership. IMPLICATIONS FOR PRACTICE Identification of women at risk of mood disturbance may allow clinicians to intensify symptom management. Mood disturbance early in the treatment trajectory warrants management to improve outcomes.

153 Background: The long-term symptoms from COVID-19 (C19) infection in pts with cancer is not fully known. To monitor the evolution of this symptom burden over time, we designed and implemented a C19-specific patient-reported outcome (PRO) measure that integrated with a known measure of cancer symptom burden. Methods: Within the institutional initiative on C19 and cancer named Data-Driven Determinants for C19 Oncology Discovery Effort (D3CODE), pts with cancer & PCR-pos C19 are invited to participate in this longitudinal study. Pts complete the EQ-5D-5L, the 13 symptom severity & 6 interference items of the core MD Anderson Symptom Inventory (MDASI)+14 COVID-specific items, all scored on a 0-10 scale, 0 = none, 10 = worst imaginable. Pts complete the survey daily x 14 days from positive test date, then weekly x 3months, then monthly x 2yrs. Demographic and disease information was collected. Psychometric procedures determined validity and reliability of the MDASI-COVID. Results: Between 5/15/20 – 02/14/21, 2154 pts w PCR-confirmed C19 were invited to participate in the longitudinal study. 1282 (60%) pts provided consent and began the longitudinal completion of PRO surveys. Pts were 54.5% Female and 45.5% Male, median age 59 years (range 15 – 92). 1021 (80%) are White/Caucasian, 206 (16%) Hispanic, 113 (9%) African American, and 39 (3%) Asian. The validation analysis of MDASI-COVID instrument included the 1st 600 pts where the mean overall health rating on EQ-5D-5L was 78.3 (SD 19.6), best being 100. Highest mean (M) severity symptoms on the MDASI-COVID were fatigue (M 3.45, SD 2.17), drowsiness (M 2.50, SD 2.89), sleep disturbance (M 2.44, SD 2.99), malaise (M 2.37, SD 3.05), and distress (M 2.27, SD 2.90). Most severe (≥ 7) symptoms) reported were fatigue (21.3% of pts), change in taste (14.8%), change in smell (14.4%), malaise (14.3%), sleep disturbance (14.3%), and drowsiness (14%). showed internal consistency (Cronbach α) of the 27 symptom items was 0.957, of the 6 interference items was 0.937. Mean severity of the 27 symptom items was significantly correlated with overall EQ-5D-5L health rating (correlation = -0.45, P < 0.0005), demonstrating concurrent validity. Mean symptom severity and interference showed known-group validity between pts who required hospitalization (symptom M 2.32, SD 2.09; interference M 3.29, SD 3.02) and those who did not (symptom M 1.69, SD 1.85; interference M 2.20, SD 2.64) (symptom P 0.007; interference P 0.004). Conclusions: We successfully deployed a PRO-based long-term symptom monitoring platform for pts with C19 and cancer. The validation analysis of this novel C19 specific PRO, the MDASI-COVID, aids in the quantification of the global symptom burden in pts with both cancer and COVID-19 infection. Deployment of this measure in the ongoing longitudinal observational cohort allows for in-depth understanding of the long-term symptoms related to C19 and cancer.

Purpose/objectives To examine self-reported severity of fatigue and disturbed sleep experienced daily by women with breast cancer during multiple cycles of chemotherapy, exploring potential classes of women experiencing similar symptom trajectories. . Design In a secondary analysis, classes of women experiencing similar patterns of fatigue and disturbed sleep were identified. . Setting Oncology clinics in the United States. . Sample 166 women with breast cancer receiving chemotherapy. . Methods Severity scores were self-reported daily using an automated system. Classes of fatigue and disturbed sleep severity were identified using latent growth mixture modeling. . Main research variables Fatigue, disturbed sleep, age, stage of disease, education, employment, marital status, chemotherapy regimen, hours lying down, and missed work. . Findings Three fatigue classes were identified. Conclusions Patterns of symptom trajectories for fatigue and disturbed sleep were distinguished by baseline symptom severity. . Implications for nursing Identification of women at risk for fatigue and disturbed sleep may allow clinicians to intensify symptom management.

12113 Background: The symptom burden experienced by patients with cancer who contract the COVID-19 (C19) infection remains to be fully understood. To accurately assess this symptom burden, we developed a valid, reliable patient-reported outcome (PRO) measure of C19 symptoms combined with a known measure of cancer symptom burden. Methods: Within the institutional initiative on COVID-19 and cancer named Data-Driven Determinants for COVID-19 Oncology Discovery Effort (D3CODE), patients with cancer and PCR-positive C19 tests were invited to participate in this longitudinal study after providing consent. Pts completed the EQ-5D-5L and the 13 symptom severity and 6 interference items of the core MD Anderson Symptom Inventory (MDASI) plus 14 COVID-specific symptom items generated from literature and expert review. Items were measured on a 0-10 scale, 0 = none to 10 = worst imaginable symptom or interference. Demographic and disease information was collected. Psychometric procedures determined validity and reliability of the MDASI-COVID. Results: 600 pts enrolled, mean age 56.5y (range 20 to 91y). 59% female, 80% white. 78% solid tumors, 19% heme cancers. 12.5% required hospitalization for C19. Median number of days between positive C19 test and PRO completion was 17 days. Mean overall health rating on EQ-5D-5L was 78.3 (SD 19.6), best being 100. Highest mean (M) severity symptoms on the MDASI-COVID were fatigue (M 3.45, SD 2.17), drowsiness (M 2.50, SD 2.89), sleep disturbance (M 2.44, SD 2.99), malaise (M 2.37, SD 3.05), and distress (M 2.27, SD 2.90). Most severe (≥ 7) symptoms) reported were fatigue (21.3% of pts), change in taste (14.8%), change in smell (14.4%), malaise (14.3%), sleep disturbance (14.3%), and drowsiness (14%). Internal consistency (Cronbach α) of the 27 symptom items was 0.957, of the 6 interference items was 0.937. Mean severity of the 27 symptom items was significantly correlated with overall EQ-5D-5L health rating (correlation = -0.45, P < 0.0005), demonstrating concurrent validity. Mean symptom severity and interference showed known-group validity between patients who required C19 hospitalization (symptom M 2.32, SD 2.09; interference M 3.29, SD 3.02) and those who did not (symptom M 1.69, SD 1.85; interference M 2.20, SD 2.64) (symptom P 0.007; interference P 0.004). Conclusions: We have validated a novel PRO, the MDASI-COVID, to quantify the combined symptom burden in patients with cancer and COVID-19. This measure allows longitudinal evaluation of COVID-19 on cancer symptom burden and provide clinicians with an accurate tool for ongoing symptom assessment and management. Longitudinal analysis on long-term symptoms related to COVID-19 and cancer are ongoing.

6510 Background: Most COVID-19 (C19) vaccine trials excluded patients with active cancer. Here, we report our real-world patient-reported and clinical outcomes of BNT162b2 mRNA C19 vaccine in patients with cancer. Methods: Our institutional Data-Driven Determinants for COVID-19 Oncology Discovery Effort (D3CODE) follows a longitudinal observational cohort of pts w cancer getting C19 vaccine. Pts complete a validated PRO tool, MD Anderson Symptom Inventory (MDASI, 13 core, 6 interference plus 17 items of symptoms from prior vaccine trials) pre-dose 1, then daily x 6d, then weekly, then on day of dose 2, then daily x 6d, then weekly x 3w. Demographics, cancer variables, prior immune checkpoint inhibitors (ICI), C19 status pre- & post-vaccine are aggregated via Syntropy platform: Palantir Foundry. Primary outcome is incidence of PRO symptoms bw dose 1 & 2 across AYA 15-39y, mid-age 40-64y & senior 65y+ cohorts. Secondary outcomes include PRO symptom incidence post-dose 2, post-vaccine change in cancer symptoms, post-vaccine symptom severity based on prior ICI, and confirmed C19 > 7 days post-dose 2. First planned 8-wk interim analysis is reported here. Results: 6388 pts w cancer (4973 w mets) received a BNT162b2 vaccine dose (4811 both doses, 1577 received one & await dose 2). Overall, median age 64y (range 16-95y); 382 AYAs, 2927 mid-age, 3079 seniors (65-70y n = 1158, 70-79y n = 1521, 80-89y n = 378, 90y+ n = 22). 4099 (64%) are White, 823 (13%) AA, 791 (12%) Hispanic, 441 (7%) Asians. Primary cancers: breast (1397), GU (821), heme (775), thoracic/HN (745), and CRC (385). Prior to dose 1, 1862 had no prior systemic tx while 4526 pts did including 3243 who had only non-IO tx (chemo, targeted tx), 1,283 had immunotherapy including 857 who had ICIs prior to dose 1. Patient-reported symptoms after C19 Vaccine: Of 6388 pts, 4714 (74% response rate, median age 67y, range 16-95y) completed 16485 PRO surveys. After 2 doses, seniors reported lower mean scores vs mid-age or AYAs on 22 of 36 symptoms including injection site pain, palpitations, itch, rash, malaise, fevers/chills, arthralgia, myalgia, headache, pain, fatigue, nausea, disturbed sleep, distress (p < 0.05). Pts w prior ICIs had higher severity of itch, rash (p < 0.05) from baseline after both dose 1 & 2 vs pts without systemic tx. Post dose 1, pts with prior ICI had higher increase in fatigue, malaise, itch, rash, myalgia, anorexia from their baseline vs pts without systemic tx (p < 0.05). C19 Outcomes: Of 6388 pts, 616 had a C19 test at any time post-dose 1: 23 (0.36%) tested positive of whom 20 (0.3%) were between dose 1 & 2; two (0.031%) were within 7 days post-dose 2, and one patient (0.016%) tested positive 16 days after dose 2, requiring admission. Conclusions: This real-world observational cohort demonstrates post-vaccine symptom burden and outcomes in patients with cancer. Second interim analysis is planned at 16 weeks.

The American Cancer Society predicted that 266,120 women would be diagnosed with breast cancer in 2018. Women experience significant symptom burden in response to tumor and treatment-related adverse effects, particularly in advanced disease. Use of valid and reliable patient-reported outcomes (PRO) symptom measures may assist clinicians in systematically monitoring and managing symptoms. The MD Anderson Symptom Inventory (MDASI) is a brief PRO measure of cancer symptom burden; specific symptoms can be added to the core symptoms to produce disease- and treatment-specific modules. The purpose of this study was to describe the patient symptom experience, define the content domain, and generate items for a breast cancer-specific MDASI module for measuring symptom burden in women with breast cancer. Women with breast cancer were qualitatively interviewed about their experiences of disease and treatment. Descriptive exploratory analysis identified symptoms and symptom interference to define the symptom burden of breast cancer. An expert panel rated the relevance of the identified symptoms to patients with breast cancer. A conceptual model of breast cancer symptom burden was developed from interviews with 36 women (mean age of 57.9 years, 86.1% had stages I–III, and 52.8% were on chemotherapy and/or radiation therapy) across the breast cancer disease and treatment trajectory. Thirty-six symptoms and 6 interference categories were identified. Symptoms specific to treatment modalities and breast cancer met the criteria for inclusion in the provisional instrument for psychometric testing. We generated an instrument with content validity for measuring symptom burden specific to women with breast cancer.

Malignant pleural mesothelioma (MPM) is an aggressive cancer of the lung pleura. The MD Anderson Symptom Inventory (MDASI) is a patient-reported outcome (PRO) measure of symptom burden, the combined impact of disease-related and treatment-related symptoms on functioning. Validated PRO measures may require modification for use in specific study populations. We sought to modify the MDASI for patients with MPM and create a fit-for-purpose symptom-burden measure for use in a clinical trial, according to US Food and Drug Administration guidance on PRO utilization to support labeling claims. A literature review for MPM symptoms was conducted. Patients with MPM were qualitatively interviewed about experiences of disease and treatment. Descriptive analysis identified symptoms and interference with functioning to define MPM-related symptom burden. An expert panel rated the relevance of identified symptoms to patients with MPM. Patients who received the investigational drug in a previous Phase I study were interviewed for drug-specific symptoms. Literature review and interviews of 20 patients identified 31 MPM-related symptoms. A conceptual model of MPM-related symptom burden was developed. After expert-panel relevance review, five MPM-specific items and the 13 core MDASI symptoms met criteria for inclusion in a provisional MDASI-MPM for psychometric testing. Interviews with six patients identified six drug-specific symptoms; three were mentioned by multiple patients. Of these three, one was not in the core MDASI. The MDASI-MPM has established content validity and, with the addition of one symptom item, is ready for psychometric testing as fit-for-purpose for a clinical trial of an investigational agent.

Poorly controlled symptoms are common and debilitating during cancer treatment and can affect functional status and quality of life, health care resource utilization, treatment adherence, and cancer survivorship. Historically, the patient experience, including symptoms during treatment, has not been tracked or documented in the patient health record. Measurement of patient-reported outcomes (PROs), including symptoms, is an essential component to cancer care focused on the illness impact to the patient and family. PROs can be useful at the individual level for monitoring and promoting symptom care both in the clinic and remotely and at the population level for aggregating population data for use in research and quality improvement initiatives. Implementation of PROs in cancer clinical care requires a carefully thought out process to overcome challenges related to integrating PROs into existing electronic health records and clinical work flow. Issues with implementing PRO collection may include making decisions about measurement tools, modes of delivery, frequency of measurement, and interpretation that are guided by a clarification of the purpose for collecting PROs. We focus on three aspects of PRO use: (1) improving care for individual patients, (2) analyzing aggregated data to improve care and outcomes overall, and (3) considerations in implementing PRO collection.

Technology‐aided remote interventions for poorly controlled symptoms may improve cancer symptom outcomes. In a randomized controlled trial, the efficacy of an automated symptom management system was tested to determine if it reduced chemotherapy‐related symptoms. Prospectively, 358 patients beginning chemotherapy were randomized to the Symptom Care at Home (SCH) intervention (n = 180) or enhanced usual care (UC) (n = 178). Participants called the automated monitoring system daily reporting severity of 11 symptoms. SCH participants received automated self‐management coaching and nurse practitioner (NP) telephone follow‐up for poorly controlled symptoms. NPs used a guideline‐based decision support system. Primary endpoints were symptom severity across all symptoms, and the number of severe, moderate, mild, and no symptom days. A secondary endpoint was individual symptom severity. Mixed effects linear modeling and negative binominal regressions were used to compare SCH with UC. SCH participants had significantly less symptom severity across all symptoms (P

Purpose/objectives To explore the experience of informal caregivers of patients with a primary brain tumor by identifying themes of the caregiving experience specific to this population. Research approach Qualitative study employing Parse's descriptive exploratory method. Setting National Cancer Institute-designated comprehensive cancer center in a major city in the southern United States. Participants 20 patients with primary brain tumors and their caregivers. Methodologic approach Data collection involved a tape-recorded dialogue with caregivers using Story Theory. Patient and caregiver demographic information was collected. Main research variables Concepts of commitment, expectation management, role negotiation, self-care, new insight, and role support. Findings Caregivers of patients with primary brain tumors used the energy sources identified by the Model of Informal Caregiving Dynamics. Commitment is sustained through enduring patient cognitive and behavioral decline. Expectations are based on a realistic understanding of the disease trajectory and known mortality, and allow caregivers to hope for the ability to manage declining patients. Caregivers express difficulty in gauging the behavior of cognitively impaired patients. Healthcare providers support caregivers by supplying information and listening to caregivers' stories. In contrast to a similar study involving caregivers of bone marrow transplantation recipients, these caregivers reported negative perceptions. Conclusions Commitment, expectation management, role negotiation, self-care, new insight, and role support motivate informal caregivers of patients with primary brain tumors in a unique way. Interpretation Healthcare providers can support the caregiving experience by validating efforts, providing information, and listening to frustrations. Additional research should explore interventions aimed at assisting caregivers.