Improving symptom management for survivors of young adult cancer: rationale and study protocol for a pilot randomized controlled trial.

BACKGROUND: Young adult (YA) cancer survivors are a growing, yet underserved population who often face significant and long-lasting cancer-related physical (e.g., pain, fatigue) and emotional (e.g., psychological distress) symptoms. Post-treatment symptoms can persist, disrupting YA's abilities to complete goals consistent with their developmental stage (e.g., completing their education, achieving autonomy and independence, building their careers, establishing peer and romantic relationships, building their families). While symptom management has been identified as a significant issue in YA's transitions to survivorship, the symptom management needs of this population largely go unmet. METHODS: We developed an eight-session, group-based behavioral intervention that is delivered using videoconferencing to address the unique symptom management needs of YA cancer survivors. The intervention was developed in conjunction with YA survivors, leading to the novel combination of traditional behavioral symptom coping strategies, home-based physical activity, strategies from contemporary cognitive-behavioral approaches (e.g., those derived from acceptance and commitment therapy, strategies to foster self-compassion), concepts from meaning centered psychotherapy, and behavioral strategies to improve communication and health care engagement. Participants receive printed intervention materials and access to a study-specific mobile application, both of which are used throughout the program. Herein, we report on a pilot study that is in progress. Recruitment has been completed. YA cancer survivors were recruited in cohorts of n = 10 or n = 11 (n = 61) and randomized to the intervention or waitlist control arms. All participants completed a baseline assessment and four additional assessments over 1 year, with each involving a battery of self-report measures. DISCUSSION: The primary objective is to evaluate intervention feasibility and acceptability. As a secondary objective, we will examine patterns of change in intervention targets (i.e., pain, fatigue, emotional distress, symptom interference). Changes from baseline among intervention targets will be estimated for each patient and compared between arms using unadjusted statistical testing. Unadjusted and adjusted multilevel modeling will be used to estimate the effect of the intervention on changes in intervention targets. Interaction models will be used to compare the trajectory of change over time between arms. We expect that this pilot trial will inform our future approach to identify, recruit, and retain participants and provide preliminary data to support a larger, fully powered randomized controlled trial evaluating the intervention. TRIAL REGISTRATION: NCT04035447 at clinicaltrials.gov; registered July 29, 2019.

Adoption as an Alternative Family-Building Strategy: Perceptions of Female, Young Adult Cancer Survivors Receiving Gonadotoxic Treatments.

Female survivors of young adult (YA) cancers are at risk of fertility impacts following cancer treatment. For these women, fertility-related distress is both prevalent and persistent. Yet there is little research regarding survivors' perspectives on alternative family-building options, particularly adoption. This exploratory secondary data analysis analyzed semistructured interviews and explored survivors' views of adoption. Overall, female YA survivors reported openness to adoption as a possible substitute for biological conception and an alternative to fertility preservation. It is imperative that this population receives support in decision-making around and consideration of the unique barriers to adoption for cancer survivors.

Impact of Financial Costs on Patients' Fertility Preservation Decisions: An Examination of Qualitative Data from Female Young Adults with Cancer and Oncology Providers.

Purpose: To examine the impact of financial costs on fertility preservation decisions among female young adults (YAs) with cancer. Methods: Female YAs (N = 18; aged 21-36) with a history of cancer and oncology providers (N = 12) were recruited from an National Cancer Institute-designated comprehensive cancer center in a state without insurance coverage for fertility preservation. YAs and providers completed individual interviews and a brief online assessment. Qualitative description using thematic analysis was used to identify, analyze, and report common themes. Descriptive statistics was used to characterize the sample. Results: Female YAs and oncology providers highlighted the critical role that high out-of-pocket costs play in YAs' fertility preservation decisions along with the value that enhanced insurance coverage for fertility preservation would have for increasing female YAs' access to and utilization of fertility preservation. Although providers were concerned about preservation costs for their patients, they reported that their concerns did not impact whether they referred interested female YAs to reproductive specialists. Oncology providers expressed concern about inequities in utilization of fertility preservation for female and racially/ethnically minoritized YAs that were exacerbated by the high out-of-pocket fertility preservation costs. Conclusion: Cost is a significant barrier to fertility preservation for female YA cancer patients. Female YAs of reproductive age may benefit from decision support tools to assist with balancing the cost of fertility preservation with their values and family building goals. Policy-relevant interventions may mitigate cost barriers and improve access to care.

Now or Later? Patient Satisfaction and Anxiety Among Women Undergoing Breast Biopsies Performed the Same Day as Recommended Versus a Later Day.

PURPOSE: The aim of this study was to determine differences in patient satisfaction and anxiety among women undergoing core-needle breast biopsies performed the same day as recommended versus a future date. METHODS: After institutional review board exemption was granted, a survey was administered to patients at four sites on the day of imaging-guided core-needle breast biopsy. The survey was available from November 2020 through January 2022. Questions pertained to biopsy timing (same day versus later day), pre- and postbiopsy satisfaction with overall breast-care experience, biopsy wait-time satisfaction, pre- and postbiopsy anxiety, radiologist-patient communication, demographics, life stressors, breast cancer history, and risk factors. Comparisons were made between same-day and later-day biopsies by multivariable analysis. RESULTS: Of 974 respondents (response rate 65.6%), almost half were scheduled for same-day biopsies (47.8% [466 of 974]). In multivariate analyses, same-day biopsies were associated with higher prebiopsy overall breast-care satisfaction (P < .001), higher wait-time satisfaction (P < .001), and higher prebiopsy (P = .001) and postbiopsy anxiety (P = .001). Better radiologist-patient communication was associated with lower prebiopsy anxiety (P < .001) and greater prebiopsy overall (P < .001) and wait-time (P < .001) satisfaction. Compared with White women, Black women reported lower postbiopsy anxiety (P < .001) but also lower prebiopsy satisfaction (P = .03) and wait-time satisfaction (P < .001). CONCLUSIONS: Same-day versus later-day biopsies resulted in better prebiopsy overall breast-care and wait-time patient satisfaction scores; however, no satisfaction differences were noted after biopsy. Clinically significant anxiety was associated with both same- and later-day biopsies but was higher for same-day biopsies. Higher anxiety levels correlated with lower overall satisfaction, suggesting that interventions to reduce anxiety and improve communication could improve patient experiences during same-day biopsies.

Psychological distress and pain related to gynecologic exams among female survivors of sexual and physical violence: A systematic review.

Gender-based violence is prevalent globally, yet the impacts of sexual and physical violence on women's experiences of routine gynecologic care are not well understood. The purpose of this systematic review of quantitative research is to describe (a) psychological distress and pain related to gynecologic exams among female survivors of sexual and physical violence and (b) differences in distress or pain between survivors and women without this history. Fourteen articles based on 12 discrete studies met the inclusion criteria. Studies were heterogeneous, with a moderate risk of bias; therefore, a descriptive summary approach was utilized rather than a meta-analytic approach. Synthesized results indicated that survivors of violence experience mild-to-severe levels of distress and mild-to-moderate levels of pain related to gynecologic exams. The findings suggest that survivors of sexual or physical violence experience higher levels of distress than women without this history (i.e., moderate to severe), and this difference was further accentuated among women with more severe posttraumatic stress symptoms (PTSS). Differences in pain by violence history and PTSS severity were not consistently observed, possibly due to a lack of variability in ratings and small sample sizes. Additional research is needed that bolsters the measurement of exam-related distress and pain, adjusts for confounding variables, and explores mechanisms by which sexual and physical violence impact care experiences. Further empirical work will be critical to developing interventions at the patient and provider levels to improve women's experiences of care.

Relationships Between Burnout and Resilience: Experiences of Physical Therapists and Occupational Therapists During the COVID-19 Pandemic.

OBJECTIVE: Research on burnout among physical therapists and occupational therapists in the context of the coronavirus disease 2019 (COVID-19) pandemic is limited. Resilience may be important for reducing burnout and promoting well-being among rehabilitation specialists, especially during periods of elevated occupational demand and stress. The purpose of this study was to investigate experiences of burnout, COVID-19 pandemic-related distress, and resilience among physical therapists and occupational therapists during the first year of the COVID-19 pandemic. METHODS: Physical therapists and occupational therapists working in a university-affiliated health system were invited to complete an online survey assessing burnout, COVID-19 pandemic-related distress, state- and trait-like resilience, physical activity, sleep disturbance, and financial concerns. Multiple linear regressions were used to examine variables associated with burnout as well as the contribution of specific aspects of resilience to burnout. RESULTS: Greater COVID-19 pandemic-related distress was associated with greater emotional exhaustion and depersonalization, whereas state-like resilience at work was associated with lower emotional exhaustion, greater personal accomplishment, and lower depersonalization. Analyses examining the impact of specific components of resilience at work suggested that several components are associated with less burnout, with finding one's calling being particularly relevant for all 3 domains of burnout. CONCLUSION: Symptoms of burnout were reported by many physical therapists and occupational therapists. COVID-19-related distress and state-like resilience at work, particularly the perception of finding one's calling, emerged as consistently being associated with burnout in the context of the COVID-19 pandemic. IMPACT: These findings can inform the development of interventions to reduce burnout among physical therapists and occupational therapists amid the continuing COVID-19 pandemic.

Behavioral cancer pain intervention dosing: results of a Sequential Multiple Assignment Randomized Trial.

ABSTRACT: Behavioral pain management interventions are efficacious for reducing pain in patients with cancer. However, optimal dosing of behavioral pain interventions for pain reduction is unknown, and this hinders routine clinical use. A Sequential Multiple Assignment Randomized Trial (SMART) was used to evaluate whether varying doses of Pain Coping Skills Training (PCST) and response-based dose adaptation can improve pain management in women with breast cancer. Participants (N = 327) had stage I-IIIC breast cancer and a worst pain score of > 5/10. Pain severity (a priori primary outcome) was assessed before initial randomization (1:1 allocation) to PCST-Full (5 sessions) or PCST-Brief (1 session) and 5 to 8 weeks later. Responders ( > 30% pain reduction) were rerandomized to a maintenance dose or no dose and nonresponders (<30% pain reduction) to an increased or maintenance dose. Pain severity was assessed again 5 to 8 weeks later (assessment 3) and 6 months later (assessment 4). As hypothesized, PCST-Full resulted in greater mean percent pain reduction than PCST-Brief (M [SD] = -28.5% [39.6%] vs M [SD]= -14.8% [71.8%]; P = 0.041). At assessment 3 after second dosing, all intervention sequences evidenced pain reduction from assessment 1 with no differences between sequences. At assessment 4, all sequences evidenced pain reduction from assessment 1 with differences between sequences ( P = 0.027). Participants initially receiving PCST-Full had greater pain reduction at assessment 4 ( P = 0.056). Varying PCST doses led to pain reduction over time. Intervention sequences demonstrating the most durable decreases in pain reduction included PCST-Full. Pain Coping Skills Training with intervention adjustment based on response can produce sustainable pain reduction.

Improving Symptom Management for Survivors of Young Adult Cancer: Development of a Novel Intervention.

Purpose: Improved symptom management is a critical although unmet post-treatment need for young adult (YA) cancer survivors (aged 18-39 at diagnosis). This study aimed to develop and refine a behavioral symptom management intervention for YA survivors. Methods: Phase I: YA survivors (N = 21) and oncology providers (N = 11) completed individual interviews and an online, self-report assessment to examine symptom experiences, the need for a behavioral symptom management intervention for YAs, and perceptions about potential intervention components, structure, and format. Phase II: YA survivors (N = 10) completed user testing sessions, providing feedback on the prototype intervention materials (paper manual and mobile application), and completed an online assessment. Quantitative data were examined using descriptive statistics. Rapid qualitative analysis, a methodologically rigorous standardized approach, was used. Results: Pain, fatigue, and distress were ranked as top concerns by most YAs and providers. Phase I interviews underscored the need for a symptom management intervention for YAs. YAs and providers highlighted potential coping strategies and program format/structure suggestions (e.g., small group format) to best meet YAs' needs. A prototype intervention was developed combining the following: traditional behavioral symptom coping skills; home-based physical activity; strategies from Acceptance and Commitment Therapy and Meaning-Centered Psychotherapy; and strategies to foster self-compassion. Phase II user testing sessions highlighted strengths and suggestions for refining the prototype materials. Conclusion: Post-treatment symptoms are common for YAs. A tailored behavioral symptom management program was developed and refined with input from YAs and providers and will be examined for feasibility and acceptability in a pilot randomized controlled trial. Clinical Trial: Clinicaltrials.gov identifier NCT04035447.

Improving well-being for individuals with persistent pain after surgery for breast cancer, lobular carcinoma in situ, or ductal carcinoma in situ: A randomized clinical trial.

>276,000 Americans will be diagnosed with invasive breast cancer, lobular carcinoma in situ, or ductal carcinoma in situ this year and most will undergo breast surgery as part of their care. Although prognosis is excellent, many patients experience persistent post-surgical pain (PSP), which has no satisfactory pharmacological treatment. The causal contributions of pain-associated psychological factors (e.g., catastrophic thoughts about pain, psychological flexibility, self-efficacy) to the continuing burden of PSP have not yet been determined and may be opportune intervention targets. The randomized trial described here will compare the benefits of three manualized behavioral interventions for individuals with PSP. Participants will receive either: 1) self-guided health education (SGHE); 2) interventionist-guided health education (IGHE); or 3) interventionist-guided pain coping skills training with elements of acceptance and commitment therapy that specially target catastrophic thoughts about pain, self-efficacy, and psychological flexibility (CST-PSP). Participants will prospectively complete validated assessments of primary outcomes (PSP severity and interference) at baseline (pre-intervention) and 3-, 6-, and 12-months later. Validated measures of emotional distress and cancer-specific distress will be assessed as secondary outcomes. To test their roles as drivers of PSP, catastrophic thoughts about pain, self-efficacy, and psychological flexibility, will be assessed and statistically analyzed as mediators of hypothesized beneficial effects. The interventions' impacts on pain sensitivity and central sensitization will be investigated to test these physiological pathways as proximal drivers of PSP. To better characterize the patient experience, additional validated measures will be explored for associations with PSP, along with demographic and clinical factors. Trial registration: https://clinicaltrials.gov/ct2/show/NCT04225585, registered January 13, 2020.

DEVELOPMENT, FEASIBILITY, AND ACCEPTABILITY OF A BEHAVIORAL WEIGHT AND SYMPTOM MANAGEMENT INTERVENTION FOR BREAST CANCER SURVIVORS AND INTIMATE PARTNERS.

BACKGROUND: Weight gain is common for breast cancer survivors and associated with disease progression, recurrence, and mortality. Traditional behavioral programs fail to address symptoms (i.e., pain, fatigue, distress) experienced by breast cancer survivors that may interfere with weight loss and fail to capitalize on the concordance in weight-related health behaviors of couples. This study aimed to develop and examine the feasibility and acceptability of a behavioral weight and symptom management intervention for breast cancer survivors and their intimate partners. MATERIALS AND METHODS: Interviews were conducted with N=14 couples with overweight/obesity to develop the intervention. Intervention feasibility and acceptability were examined through a single-arm pilot trial (N=12 couples). Patterns of change in intervention targets were examined for survivors and partners. RESULTS: Themes derived from interviews were used to develop the 12-session couple-based intervention, which included components from traditional behavioral weight management interventions, appetite awareness training, and cognitive and behavioral symptom management protocols. Couples also worked together to set goals, create plans for health behavior change, and adjust systemic and relationship barriers to weight loss. Examples were tailored to the experiences and symptom management needs of breast cancer survivors and partners. The intervention demonstrated feasibility (attrition: 8%; session completion: 88%) and acceptability (satisfaction). Survivors and partners experienced reductions in weight and improvements in physical activity, eating behaviors, emotional distress, and self-efficacy. Survivors evidenced improvements in fatigue and pain. CONCLUSIONS: A behavioral weight and symptom management intervention for breast cancer survivors and partners is feasible, acceptable, and is potentially efficacious.

Symptom Communication Preferences and Communication Barriers for Young Adult Cancer Survivors and Their Health Care Providers.

Purpose: Effective communication between young adult (YA; aged 18-39 years) cancer survivors and their health care providers is critical for managing post-treatment symptoms. Yet, little is known about YAs' and providers' preferences for and barriers to symptom communication, variables important for developing interventions to improve and optimize YA-provider communication. Methods: YA survivors (N = 21) and oncology providers (N = 11) rank ordered their preferred methods for symptom communication and top communication barriers. Interviews were conducted to obtain qualitative data (i.e., preferred methods for, barriers, and suggestions to improve symptom communication). Interviews were transcribed, and thematic qualitative analysis was used. Results: Sixty-two percent of YAs preferred communicating using the electronic messaging system affiliated with the medical record (MyChart), whereas providers (100%) preferred communicating during in-person clinic visits. Qualitative data from YAs pointed to benefits of MyChart, including ease of use and rapid responses. Providers acknowledged that, although efficient, high message volumes and expectations for rapid responses were barriers to MyChart. Providers described benefits of in-person visits, including visually assessing patients' concerns, providing immediate support, and more safely managing symptoms. Lack of time (48%) was YAs' top communication barrier, whereas providers endorsed patients not bringing up symptoms (64%). Qualitative data reflected patient-level (e.g., embarrassment/discomfort, lack of skills) and provider-level (e.g., forgetting to ask about a symptom) barriers. YAs and providers offered strategies to improve communication. Conclusion: Survivor- and provider-level communication interventions that account for YAs' and providers' differing communication preferences and directly address communication barriers unique to survivors' developmental stage may be necessary to improve symptom communication.

Home-Based Hematopoietic Cell Transplantation in the United States.

Patients undergoing allogeneic (allo) and autologous (auto) hematopoietic cell transplantation (HCT) require extensive hospitalizations or daily clinic visits for the duration of their transplantation. Home HCT, wherein patients live at home and providers make daily trips to the patient's residence to perform assessments and deliver any necessary interventions, may enhance patient quality of life and improve outcomes. We conducted the first study of home HCT in the United States to evaluate this model in the US healthcare setting and to determine the effect on clinical outcomes and quality of life. This case-control study evaluated patients who received home HCT at Duke University in Durham, North Carolina, from November 2012 to March 2018. Each home HCT patient was matched with 2 controls from the same institution who had received standard treatment based on age, disease, and type of transplant for outcomes comparison. Clinical outcomes were abstracted from electronic health records, and quality of life was assessed via Functional Assessment of Cancer Therapy-Bone Marrow Transplant. Clinical outcomes were compared with Student's t-test or Fisher's exact test (continuous variables) or chi-square test (categorical variables). Quality of life scores were compared using the Student t-test. All analyses used a significance threshold of 0.05. Twenty-five patients received home HCT, including 8 allos and 17 autos. Clinical outcomes were not significantly different between the home HCT patients and their matched controls; home HCT patients had decreased incidence of relapse within 1 year of transplantation. Pre-HCT quality of life was well preserved for autologous home HCT patients. This Phase I study demonstrated that home HCT can be successfully implemented in the United States. There was no evidence that home HCT outcomes were inferior to standard-of-care treatment, and patients undergoing autologous home HCT were able to maintain their quality of life. A Phase II randomized trial of home versus standard HCT is currently underway to better compare outcomes and costs.

Managing female sexual dysfunction.

OBJECTIVE: Provide an overview of sexual dysfunction in female urologic cancer patients, approaches for assessing sexual problems, and interventions to treat sexual dysfunction in this patient population. METHODS: A review of the literature in urologic oncology was conducted. Research on other female pelvic cancers with similar treatments was also reviewed. RESULTS: Sexual health is an important element of women's quality of life that is often not discussed and problems remain unaddressed. Urologic cancer treatments commonly result in sexual dysfunction (e.g., dyspareunia, vaginal dryness, problems with orgasm) in female patients, although more research is necessary to understand the impact of non-surgical treatments (e.g., radiation, chemotherapy, immunotherapy). As such, provider teams should complete necessary screening for sexual dysfunction during and after treatment. The 5 A's model (i.e., Ask, Advise, Assess, Assist, Arrange Follow-Up) provides a helpful guide for communicating about and addressing sexual health concerns with patients during the screening process. If it is determined that referral for further assessment and treatment of sexual dysfunction is needed, a number of non-pharmacologic (e.g., pelvic floor physical therapy; psychosexual counseling) and pharmacologic treatment approaches are available. CONCLUSION: Sexual dysfunction is common in female urologic cancer survivors. Routine assessment and appropriate referral are essential for high quality patient care.

Low-touch, team-based care for co-morbidity management in cancer patients: the ONE TEAM randomized controlled trial.

BACKGROUND: As treatments for cancer have improved, more people are surviving cancer. However, compared to people without a history of cancer, cancer survivors are more likely to die of cardiovascular disease (CVD). Increased risk for CVD-related mortality among cancer survivors is partially due to lack of medication adherence and problems that exist in care coordination between cancer specialists, primary care physicians, and cardiologists. METHODS/DESIGN: The Onco-primary care networking to support TEAM-based care (ONE TEAM) study is an 18-month cluster-randomized controlled trial with clustering at the primary care clinic level. ONE TEAM compares the provision of the iGuide intervention to patients and primary care providers versus an education-only control. For phase 1, at the patient level, the intervention includes video vignettes and a live webinar; provider-level interventions include electronic health records-based communication and case-based webinars. Participants will be enrolled from across North Carolina one of their first visits with a cancer specialist (e.g., surgeon, radiation or medical oncologist). We use a sequential multiple assignment randomized trial (SMART) design. Outcomes (measured at the patient level) will include Healthcare Effectiveness Data and Information Set (HEDIS) quality measures of management of three CVD comorbidities using laboratory testing (glycated hemoglobin [A1c], lipid profile) and blood pressure measurements; (2) medication adherence assessed pharmacy refill data using Proportion of Days Covered (PDC); and (3) patient-provider communication (Patient-Centered Communication in Cancer Care, PCC-Ca-36). Primary care clinics in the intervention arm will be considered non-responders if 90% or more of their participating patients do not meet the modified HEDIS quality metrics at the 6-month measurement, assessed once the first enrollee from each practice reaches the 12-month mark. Non-responders will be re-randomized to either continue to receive the iGuide 1 intervention, or to receive the iGuide 2 intervention, which includes tailored videos for participants and specialist consults with primary care providers. DISCUSSION: As the population of cancer survivors grows, ONE TEAM will contribute to closing the CVD outcomes gap among cancer survivors by optimizing and integrating cancer care and primary care teams. ONE TEAM is designed so that it will be possible for others to emulate and implement at scale. TRIAL REGISTRATION: This study (NCT04258813) was registered in clinicaltrals.gov on February 6, 2020.

Replicating dissemination and identifying mechanisms of implementation of an empirically supported treatment.

OBJECTIVE: Implementation research is needed in cancer control. Replication of the dissemination of empirically supported treatments (ESTs) is important as is the identification of mechanisms by which dissemination leads to implementation. Addressing these gaps, Study 1 (Cohorts 3-6, N = 104) tests for replication of a successful dissemination to community providers (Brothers et al., 2015; Cohorts 1-2; N = 62) and Study 2 (Cohorts 1-6) tests providers' changes on dissemination outcomes as mechanisms of EST usage. METHOD: The Biobehavioral Intervention (BBI), a psychological EST in cancer control, was disseminated to oncology mental health providers using manual provision, didactics, roleplays, and other strategies. Study 1 tested for pre/post changes in dissemination outcomes (BBI knowledge/skills and attitudes toward and self-efficacy to deliver ESTs/BBI) between cohorts (1-2 vs. 3-6) with repeated measures ANOVAs. In Study 2, the implementation outcome was providers' (N = 166) BBI usage with patients (percent treated). Structural equation models tested dissemination outcome changes as predictors of usage at 2- and 4-months. RESULTS: Study 1 replicated high dissemination outcomes and significant gains in BBI knowledge (p < .001) in Cohorts 3-6. Unlike Cohorts 1-2, significant gains were observed in self-efficacy (ps < .001) but not attitudes toward ESTs (p = .523) in Cohorts 3-6. In Study 2, gains in providers' self-efficacy (ps < .05) and EST attitudes (p = .008) predicted greater 2-month (58.4% ± 35.5%) and 4-month (66.2% ± 35.0%) usage of the BBI with patients, respectively. CONCLUSIONS: This is the only replication of a dissemination for a psychological EST in cancer control. Results reliably show disseminations enhancing providers' self-efficacy to use and positive attitudes toward ESTs as mechanisms for EST implementation. (PsycInfo Database Record (c) 2021 APA, all rights reserved).

Behavioral cancer pain intervention using videoconferencing and a mobile application for medically underserved patients: Rationale, design, and methods of a prospective multisite randomized controlled trial.

BACKGROUND: Women with breast cancer in medically underserved areas are particularly vulnerable to persistent pain and disability. Behavioral pain interventions reduce pain and improve outcomes. Cancer patients in medically underserved areas receive limited adjunctive cancer care, as many lack access to pain therapists trained in behavioral interventions, face travel barriers to regional medical centers, and may have low literacy and limited resources. mHealth technologies have the potential to decrease barriers but must be carefully adapted for, and efficacy-tested with, medically underserved patients. We developed an mHealth behavioral pain coping skills training intervention (mPCST-Community). We now utilize a multisite randomized controlled trial to: 1) test the extent mPCST-Community reduces breast cancer patients' pain severity (primary outcome), pain interference, fatigue, physical disability, and psychological distress; 2) examine potential mediators of intervention effects; and 3) evaluate the intervention's cost and cost-effectiveness. METHODS/DESIGN: Breast cancer patients (N = 180) will be randomized to mPCST-Community or an attention control. mPCST-Community's four-session protocol will be delivered via videoconferencing at an underserved community clinic by a remote pain therapist at a major medical center. Videoconference sessions will be supplemented with a mobile application. Participants will complete self-report measures at baseline, post-intervention, and 3- and 6-month follow-ups. CONCLUSIONS: mPCST-Community has the potential to reduce pain and disability, and decrease barriers for cancer patients in medically underserved areas. This is one of the first trials to test an mHealth behavioral cancer pain intervention developed specifically for medically underserved communities. If successful, it could lead to widespread implementation and decreased health disparities.

Factors associated with falls in older women with breast cancer: the use of a brief geriatric screening tool in clinic.

PURPOSE: Unintentional falls and breast cancer are common among older women, but the associations between them are understudied. We aimed to identify factors associated with falls in older women with breast cancer. METHODS: We retrospectively reviewed clinical records of older women with breast cancer at Duke Medical Center who had completed the Senior Adult Oncology Program geriatric assessment. Characteristics were compared between women had had at least one fall in the past year and those who did not. Pearson's Chi-square tests and t tests were used for comparison of groups' characteristics. Logistic regression determined factors associated with falling. RESULTS: We identified 425 women, age 76.2 years (range 65-89 years), at the time of the assessment. 118 (27.8%) women reported a fall in the prior year. Age, race, ethnicity, and time since diagnosis (all p > 0.05) were similar between groups. In univariate analyses, metastatic disease (p = 0.023) and history of endocrine therapy (p = 0.042) were more common among women who fell. Women who fell had lower systolic (p = 0.001), diastolic (p < 0.001) blood pressures, and SpO2 (p = 0.018). Women who had fallen had a higher Charlson Comorbidity Index (CCI: p = 0.033), and were more likely to report using a walking aide (p < 0.001), nutritional issues (p = 0.006), and depression symptoms (p = 0.038). In multivariate analysis, falling was associated with low DBP (OR 0.93; p = 0.0017), low SpO2 (OR 0.79; p = 0.0169), a higher CCI (OR 1.23; p = 0.0076), and depression symptoms (OR 1.61; p = 0.039). CONCLUSIONS: Among older women with breast cancer, depressive symptoms, higher comorbidity level, and vital sign measurements were associated with having fallen.

Improving health engagement and lifestyle management for breast cancer survivors with diabetes.

Breast cancer survivors with type 2 diabetes are at high risk for cancer recurrence, serious health complications, more severe symptoms, psychological distress, and premature death relative to breast cancer survivors without diabetes. Maintaining glycemic control is critical for decreasing symptoms and preventing serious health problems. Many breast cancer survivors with type 2 diabetes have difficulty maintaining diabetes self-management behaviors and achieving glycemic control. Both cancer and diabetes-related symptoms (e.g., physical symptoms and psychological distress) are often barriers to engaging in diabetes self-management strategies. This study evaluates a novel diabetes coping skills training (DCST) intervention for improving breast cancer survivors' abilities to manage symptoms and adhere to recommended diabetes self-management behaviors. The telephone-based DCST protocol integrates three key theory-based strategies: coping skills training for managing symptoms, adherence skills training, and healthy lifestyle skills training. A randomized clinical trial will test the DCST intervention plus diabetes education by comparing it to diabetes education alone. Symptoms, distress, diabetes self-management behaviors, and self-efficacy will be assessed at baseline and 3, 6, and 12 months. Glycosylated hemoglobin (HbA1c) will be assessed at baseline, 6, and 12 months. This study addresses a critical gap in the care of breast cancer survivors by evaluating a novel behavioral intervention to improve the management of symptoms, adherence, and glycemic control in breast cancer survivors with type 2 diabetes. Special considerations for this medically underserved population are also provided. The findings of this study could lead to significant improvements in clinical care and beneficial outcomes for breast cancer survivors. Trials registration: ClinicalTrials.gov, NCT02970344, registered 11/22/2016.