This narrative review summarizes the evidence for behavioral interventions addressing sleep disturbance (i.e., insomnia) in cancer populations. Implementation considerations and future research directions are provided. Support is strong for Cognitive Behavioral Therapy for Insomnia (CBTI) in cancer populations. Mindfulness and acceptance-based therapies show promise for improving sleep disturbance, especially when integrated with sleep restriction and stimulus control; however, comparative efficacy to CBTI should be further investigated. Psychologists most commonly deliver behavioral insomnia interventions. Recent work shows other clinicians (e.g., nurses) can also deliver these treatments, and this shift may improve the shortage of behavioral sleep providers in the oncology setting. CBTI is the “gold standard” for treating insomnia in cancer patients. Future research should expand its focus beyond breast cancer samples and examine stepped care models that leverage digital technologies (e.g., mobile applications, wearables) to address access and resources barriers limiting clinical implementation.

OBJECTIVE:To identify psychosocial and clinical predictors of psychological distress in patients with primary open-angle glaucoma (POAG). DESIGN:Prospective cross-sectional study. PARTICIPANTS:300 patients with a diagnosis of POAG were recruited from the Duke Eye Center glaucoma clinics between September 2022 and August 2023. METHODS:Participants completed validated self-report questionnaires, including the Hospital Anxiety and Depression Scale (HADS, psychological distress), Self-Efficacy for Managing Chronic Disease Scale (SE-6, self-efficacy), Modified Medical Outcomes Study Social Support Survey Scale (MOS-8, social support), and the National Eye Institute Visual Function Questionnaire Scale (NEI VFQ-9, vision-related quality of life [QoL]). Clinical data were abstracted from electronic health records. Univariable and multivariable Poisson regression models assessed associations between distress and psychosocial / clinical variables, including interaction effects. Risk ratios (RRs) and p-values were reported. MAIN OUTCOME MEASURES:Psychological distress measured by HADS. RESULTS:The cohort had a mean age of 68.4 years (52% female), with 81% identifying as White and 15% as Black/African American. Mean total HADS score was 9.21 (SD = 6.28), with 55 participants (18%) reporting significant psychological distress (HADS > 14). Younger age, female sex, lower socioeconomic indicators (education, income, employment status), and clinical markers were also found to be significant predictors of distress in univariable analyses, with age remaining significant in multivariable analyses. In univariable models, poorer vision-related QoL (RR=0.78, p <0.001), weaker social support (RR=0.78, p <0.001), and lower self-efficacy (RR=0.74, p <0.001) were all associated with greater distress. In multivariable analyses, self-efficacy (RR=0.82, p < 0.001) and social support (RR=0.83, p < 0.001) remained independently associated. Significant interaction effects were estimated between vision-related QoL and social support (RR=0.91, p < 0.001), and low social support and low self-efficacy (RR=1.06, p = 0.005), indicating combinations of psychosocial strengths and vulnerabilities may shape distress risk. CONCLUSIONS:Psychosocial variables are significant and interrelated predictors of distress in POAG, beyond what is captured by traditional clinical metrics. These findings underscore the critical role of modifiable psychosocial factors in shaping patients' emotional well-being. Integrated care models to address psychosocial needs represents an important opportunity to mitigate distress and improve glaucoma outcomes.

OBJECTIVE:To validate the Distress Thermometer (DT) as a screening tool for psychosocial distress in primary open-angle glaucoma (POAG) patients and determine optimal cutoff score for clinical use. DESIGN:A clinic-based cross-sectional study. PARTICIPANTS:Three hundred POAG patients without recent glaucoma surgery within the past 6 months were recruited from Duke Eye Center clinics between September 2022 and August 2023. METHODS:Participants completed the DT, Hospital Anxiety and Depression Scale (HADS), Self-Efficacy for Managing Chronic Disease 6-item scale, Modified Medical Outcomes Study Social Support Survey 8-item scale, and National Eye Institute Visual Functioning Questionnaire 9-item scale prior to clinic visit. Receiver operating characteristic analysis compared DT cutoff scores (4, 5, and 6) against HADS thresholds for overall distress, anxiety (HADS-A), and depression (HADS-D) subscales. Sensitivity, specificity, positive/negative predictive values, and area under the curve were calculated. Associations between distress and demographic/clinical variables were also explored. Comparison of patient characteristics was conducted between groups correctly and incorrectly classified by the DT relative to the HADS. MAIN OUTCOME MEASURES:Validity of DT in detecting clinically significant distress, as determined by HADS, with secondary outcomes of patient acceptability of DT and factors associated with distress. RESULTS:The optimal DT cutoff was 5 for detecting overall distress (HADS ≥15; sensitivity 0.78, specificity 0.76) and depression (HADS-D ≥8; sensitivity 0.84, specificity 0.73), while a cutoff of 4 best identified anxiety (HADS-A ≥7; sensitivity and specificity both 0.75). Area under the curve values were 0.83 to 0.84, indicating strong discriminative ability. Distress Thermometer negatively correlated with age, social support, self-efficacy, vision-related quality of life, intraocular pressure of the better eye, and standard automated perimetry mean deviation of the worse eye. Distress Thermometer was significantly associated with sex, marital status, income, and employment. Discrepancies between DT and HADS classification were linked to sex, distress, and social support. Patients found the DT highly acceptable (92% easy to complete; 88% not bothered by the question). CONCLUSIONS:The DT is a valid, reliable, and acceptable screening tool for psychological distress in POAG patients. Its brevity and ease of use supports implementation into routine glaucoma care, enabling early identification and intervention to improve outcomes and quality of life for distressed POAG patients. FINANCIAL DISCLOSURE(S):Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

OBJECTIVES:Behavioral management is recommended for cancer pain, yet not well integrated into clinical practice. PainPac is an asynchronous mobile application that delivers behavioral pain coping strategies. We evaluated PainPac's feasibility, acceptability, and impact on pain compared to a videoconference-delivered protocol (PCST-Video). METHODS:Participants (N = 62) were adults with a stage I-IV diagnosis of colorectal cancer within the past two years and pain ≥4 on 0-10 scale from an academic cancer center. Participants were randomized 1:1 to PainPac or PCST-Video. Feasibility (accrual [N = 60/15 months]; attrition at the post-treatment assessment [primary endpoint; <25%]; adherence to all assessments and intervention modules/sessions [>75%]), burden (number of modules/sessions completed; time from baseline to completion of first module/session; time to complete all sessions/modules), engagement (skills practice and PainPac log in >3 times/week), and acceptability (≥80% of participants reporting ≥75% satisfaction on Client Satisfaction Questionnaire) were assessed. Changes in pain and pain-related outcomes were explored at baseline (A1), post-treatment (A2), and 1-month post-treatment (A3). RESULTS:Feasibility exceeded prespecified benchmarks (N = 62/10 months; 92% A2 retention). Ninety percent of PainPac participants completed all modules (Msessions=3.77, SD=.82); 80% of PCST-Video participants completed all sessions (Msessions=3.37, SD = 1.33). Participants moved from A1 to completion of first module/session in 1 day for PainPac and 12 days for PCST-Video. Number of days to complete all modules/sessions was M = 23.57 (SD = 5.31) for PainPac and M = 27.63 (SD = 6.70) for PCST-Video. PainPac engagement exceeded prespecified benchmarks (M = 9.22 app logins per week). Satisfaction was high with PainPac (89.3% ≥24; M = 28.11, SD = 3.74) and PCST-Video (92.6% ≥24; M = 28.93, SD = 3.57). Pain outcomes changed in the expected direction for both conditions, improving from A1 to A3. DISCUSSION:PainPac is a promising approach for improving cancer pain management. Technology-based behavioral interventions can decrease barriers and improve intervention reach, scalability, and sustainability in clinical practice. Larger, well-powered randomized trials are needed to test PainPac's efficacy. CLINICAL TRIAL REGISTRATION NUMBER:ClinicalTrials.gov, NCT05686122.

BACKGROUND:Patients undergoing hematopoietic stem cell transplant (HCT) and chimeric antigen receptor T-cell (CAR-T) therapy experience significant disability exacerbated by persistent fatigue, pain, and psychological distress. These symptoms limit physical activity, one of the most effective and recommended strategies for reducing disability. Cognitive behavioral interventions improve cancer-related symptoms but have not been adapted for this unique patient population. METHODS/DESIGN:This randomized controlled trial will test Step Up, a hybrid-delivered (in-person and mobile health) intervention that integrates cognitive behavioral symptom management with occupational therapy (OT)-led activity coaching. Adults (N = 177) post-HCT or CAR-T who report ≥2 target symptoms (fatigue, pain, psychological distress) at moderate levels (≥3/10) will be randomized 1:1 to Step Up or Usual Care Plus. Step Up includes seven weekly sessions: three in-person during intensive outpatient care and four videoconferencing at home, supported by a mobile app with activity trackers and personalized feedback. Usual Care Plus provides seven educational videos and activity monitoring. The primary outcome is physical disability assessed post-intervention (10-14 weeks after baseline). Secondary outcomes include fatigue, pain, psychological distress, daily steps, self-efficacy for symptom management, and digital symptom biomarkers (e.g., sleep). Assessments occur at baseline, post-intervention, and 3- and 6-month follow-ups. CONCLUSION:This is the first trial to test a hybrid-delivered, theory-based intervention integrating symptom management and OT-led activity coaching for HCT and CAR-T patients. Step Up may reduce physical disability and improve clinical outcomes. If successful, it could lead to widespread implementation to improve recovery during the critical transition from intensive outpatient care to home.

Objective:To assess the feasibility and acceptability of VISON-ACT, a standalone, mobile app psychosocial intervention for psychological distress in individuals with primary open-angle glaucoma (POAG). Design:Single-arm pilot. Participants:Patients (N=28) with a diagnosis of POAG, self-reporting at least mild (≥3) distress on the 4-item Patient Health Questionnaire, were recruited from the Duke Eye Center between April 2025-December 2025. Methods:Patients (n=28) were consented and completed a baseline (A1) self-report assessment. VISION-ACT was comprised of 6 weekly modules. Follow-up self-report assessments occurred at post- (A2) and 1-month post-intervention (A3) and included measures of psychological distress, vision and health-related quality of life, psychological flexibility, disease acceptance, self-efficacy for symptom management, mindfulness, and social support. Participants were invited to complete an exit interview at 1-month post-intervention to gather qualitative feedback on the VISION-ACT protocol. Descriptive statistics were used to assess feasibility and acceptability metrics and patterns of pre-post change on patient reported outcomes were explored with linear mixed mdels using R Statistical Software. Main Outcome Measures:Feasibility (target accrual (n=25) in 12 months, <20% attrition at post-intervention); Acceptability (≥75% reporting use of VISION-ACT skills or ideas at post-intervention, ≥80% reporting M≥3.00/4.00 at post-intervention on the Client Satisfaction Questionnaire); Psychological Distress (Hospital Anxiety and Depression Scale [HADS], Subjective Units of Distress Scale [SUDS]). Results:VISION-ACT was highly feasible; accrual target was surpassed (N=28) in 6 months, and attrition was low (3.85%) at post-intervention (A2). Acceptability was strong with 100% of participants reporting use of VISION-ACT skills or ideas at A2 and M=3.27/4.00 intervention satisfaction. Adherence was remarkable with 88.5% of participants completing all six VISION-ACT modules. Pre-post change patterns were in the expected direction for psychological distress (HADS A1 M=13.88, A2 M=11.21; SUDS A1 M=35.54, A2 M=26.46) and all other patient-reported outcomes across baseline, post- and 1-month post-intervention assessments. Data on participant perspectives highlighted valuable aspects of VISION-ACT, and areas for refinement. Conclusions:Robust feasibility and acceptability data seen here provide support a fully-powered, randomized trial to evaluate the efficacy of VISION-ACT for reducing psychological distress and improving related patient-reported and clinical outcomes.

Purpose:Psychological distress is highly prevalent in glaucoma and is associated with worse adherence, reduced quality of life, and faster disease progression. However, distress is rarely assessed in ophthalmology settings due to time, workflow, and staffing constraints. We evaluated two artificial intelligence (AI)-based screening strategies, designed to efficiently identify distressed primary open angle glaucoma (POAG) patients during routine care, aiming to achieve effective, resource conscious, low burden clinical screening. Design:Hybrid retrospective cohort and prospective cross-sectional study. Participants:The retrospective cohort included >3,000 POAG patients from the Duke Ophthalmic Registry. Prospective validation was conducted in a separate 300 POAG patient cohort who completed patient-reported distress screening. Methods:Using retrospective data, a neural network model was trained to predict an electronic health record (EHR)-derived computable phenotype of distress ("silver standard"). Prospective validation used the 8-item Patient Health Questionnaire (PHQ-8) as the "gold standard." Three screening strategies were compared against PHQ-8: (1) universal PHQ-2 screening (two-item screener administered to all patients), (2) AI-only screening (fully automated EHR-based screener), and (3) sequential screening, (only patients flagged as high risk by AI screener completed the PHQ-2). Performance metrics included sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), accuracy, and screening burden. Main Outcome Measures:Sensitivity; specificity; PPV; NPV; accuracy; proportion of patients requiring secondary screening (screening burden). Results:Distress prevalence was 17% (PHQ-8 > 6). Universal PHQ-2 screening (> 0) achieved high sensitivity (0.96) but lower specificity (0.73) and PPV (0.41), while requiring screening of all patients. The AI-assisted sequential approach substantially reduced screening burden while maintaining strong diagnostic performance. By administering PHQ-2 to ~25% of patients, sequential screening achieved sensitivity 0.64, specificity 0.93, PPV 0.64, NPV 0.93, and accuracy 0.88, representing a ~50% increase in PPV compared to PHQ-2 alone. AI-only screening reduced burden further but did not achieve comparable sensitivity or predictive performance. Conclusions:AI-assisted sequential screening enables scalable, resource efficient identification of psychological distress in glaucoma care, substantially reducing screening burden while preserving clinically meaningful performance. This framework offers a practical pathway for integrating distress screening into routine ophthalmology workflows and improving the identification and referral of at-risk patients.

BACKGROUND:Pain from musculoskeletal pain conditions is often persistent, bothersome, and negatively impacts physical function. Individuals with musculoskeletal pain report difficulty with walking and regular activities. For some, this may be related to overly negative pain cognitions, such as pain catastrophizing and kinesiophobia. In a geographically and racially diverse sample, we examined relationships between pain catastrophizing, kinesiophobia, and multimodal physical function (i.e., self-report, performance-based, objective). METHODS:Participants were sedentary adults with ≥3 months of chronic musculoskeletal pain. Participants completed self-report measures of pain catastrophizing (Pain Catastrophizing Scale), kinesiophobia (Tampa Scale of Kinesiophobia), and physical function (World Health Organization Disability Assessment Scale 2.0). Performance-based physical function was assessed in-clinic with the Six-Minute Walk Test (6MWT). Physical function was objectively measured with ≥4 days of ActiGraph wear outside the clinic. We conducted descriptive, correlation, and linear regression statistics in SPSS. RESULTS:Higher levels of pain catastrophizing (β = 0.42) and kinesiophobia (β = 0.25) were significantly associated with worse self-reported physical function. Neither pain catastrophizing nor kinesiophobia were related to performance-based or objectively measured physical function. The direction and significance of relationships between pain catastrophizing, kinesiophobia, and physical function measures were consistent in unadjusted and adjusted regression models. CONCLUSIONS:Pain catastrophizing and kinesiophobia are associated with an individual's perceived physical functioning. Behavioral interventions designed to enhance physical function may benefit from including cognitive restructuring to challenge catastrophic thoughts about pain, as well as thoughts about injuring oneself or worsening pain with movement. More work is needed to understand why neither pain catastrophizing nor kinesiophobia were significantly associated with performance-based or objective assessment of physical function. It is possible that other pain-related cognitions, for example self-efficacy for pain control, or variables (e.g., in vivo pain catastrophizing, mood, stress, sleep) assessed closer in time to performance-based or objective measures of physical function are more relevant.

BACKGROUND:People living longer with metastatic non-small cell lung cancer (mNSCLC) experience heightened psychological distress and decrements in quality of life. Therefore, we developed LiveWell, an 8-session adapted dialectical behavioral therapy skills training (DBT-ST) protocol delivered one-on-one via telehealth to reduce psychological distress. AIM:To conduct a single-arm pilot trial examining the feasibility and acceptability of LiveWell and explore change in outcome variables. METHODS:Patients receiving systemic therapy for mNSCLC with at least mild distress participated. Outcomes were feasibility (accrual N = 30 in 18 months, > 80% sessions attended, < 25% attrition) and acceptability (> 80% participant satisfaction). Distress (depression and anxiety symptoms; primary outcomes), intolerance of uncertainty, emotion regulation, illness acceptance, symptoms (e.g., fatigue, dyspnea, pain), skill use, and quality of life (secondary outcomes) were assessed at baseline, post-intervention (primary endpoint), and 1-month post-intervention and examined with paired sample t-tests. RESULTS:Thirty participants (Mage = 63 years, 77% female) consented and completed the baseline assessment. LiveWell met feasibility (accrual N = 30 in 8 months, 93% sessions attended, 87% retention at post-intervention) and acceptability (96% satisfaction) benchmarks. Participants demonstrated reductions in distress (depression d = 0.35, anxiety d = 0.22) from baseline to post-treatment. Intolerance of uncertainty (d = 0.71), emotion regulation (d = 0.49), and illness acceptance (d = 0.45) improved. Fatigue and pain remained stable or improved (d's 0.07-0.38). Skill use increased (d = 0.65) and quality of life improved (d = 0.21). Improvements were maintained or enhanced at 1-month follow-up. CONCLUSIONS:LiveWell was feasible and acceptable, and participants demonstrated promising improvement in primary and secondary outcomes. Findings support a larger randomized efficacy trial. TRIAL REGISTRATION:ClinicalTrials.gov Identifier: NCT04973436.

A mixed-methods study of 300 glaucoma patients found strong support for screening and referral for psychological distress. Greater interest among those with elevated distress or higher intraocular pressure highlights an opportunity to integrate psychosocial support into glaucoma care.

Importance:Increasing physical function for individuals in chronic pain is challenging. Despite the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials guidelines, no pain trial has comprehensively assessed multimodal physical function (ie, self-reported, performance-based, and objective or step count-based measures), and most of these trials have limited racial and ethnic diversity. Objective:To test the feasibility of a mind-body walking program and a health education program among geographically, racially, and ethnically diverse sedentary adults with chronic pain. Design, Setting, and Participants:This single-blind, 2-arm, feasibility randomized clinical trial was conducted at Massachusetts General Hospital in the Northeast, Duke University in the Southeast, and Rush University in the Midwest, capturing a racially, ethnically, and geographically diverse US population. Recruitment occurred between April 2023 and January 2024. Participants were sedentary adults with chronic musculoskeletal pain. After baseline assessment, participants were randomized to either the mind-body walking program or the health education program. Given the pilot nature of this trial, all analyses were conducted on the observed data rather than following intent-to-treat principles. Interventions:Both interventions consisted of 10 weekly hour-long, in-person group sessions. Main Outcomes and Measures:Primary outcomes were feasibility benchmarks, including feasibility of recruitment, treatment arms, assessments, participant retention, racial and ethnic diversity attainment, treatment expectancy, treatment credibility, participant satisfaction, and treatment fidelity. Results:Ninety-two participants were randomized to the mind-body walking program (n = 47) or the health education program (n = 45). Participants had a mean (SD) age of 57 (14.3) years; were predominantly females (69 [75.0%]); and included Asian (2.2%), Black or African American (44.6%), Hispanic (5.4%), non-Hispanic (83.7%), and White (40.2%) individuals. Both mind-body walking and health education interventions met the benchmarks for feasibility of treatment arms (95.7% [44 of 46 patients] and 82.2% [37 of 45 patients]), treatment credibility (100% (41 of 41 patients] and 87.2% [34 of 39 patients]), treatment fidelity (9.93 and 9.95 scores), assessment (93.0% accuracy), and participant retention (93.6% [44 of 47 patients] and 86.7% [39 of 45 patients]). Benchmarks for treatment expectancy (85.7% [36 of 42 patients] vs 66.7% [26 of 39 patients]) and participant satisfaction (97.6% [41 of 42 patients] vs 75.0% [30 of 40 patients]) were met in the mind-body walking program but not in the health education program. The racial and ethnic diversity benchmark was met (54.3% [50 of 92] vs ≥38.0% planned). The recruitment benchmark was not met (69.7% [92 of 132] of eligible participants recruited vs ≥80.0% planned). Conclusions and Relevance:In this trial, both a mind-body walking program and a health education program were feasible at 3 geographically, racially, and ethnically diverse academic medical centers. The findings support and inform a fully powered, multisite, future efficacy trial of these interventions. Trial Registration:ClinicalTrials.gov Identifier: NCT05700383.

Importance Increasing physical function for individuals in chronic pain is challenging. Despite the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials guidelines, no pain trial has comprehensively assessed multimodal physical function (ie, self-reported, performance-based, and objective or step count-based measures), and most of these trials have limited racial and ethnic diversity. Objective To test the feasibility of a mind-body walking program and a health education program among geographically, racially, and ethnically diverse sedentary adults with chronic pain. Design, Setting, and Participants This single-blind, 2-arm, feasibility randomized clinical trial was conducted at Massachusetts General Hospital in the Northeast, Duke University in the Southeast, and Rush University in the Midwest, capturing a racially, ethnically, and geographically diverse US population. Recruitment occurred between April 2023 and January 2024. Participants were sedentary adults with chronic musculoskeletal pain. After baseline assessment, participants were randomized to either the mind-body walking program or the health education program. Given the pilot nature of this trial, all analyses were conducted on the observed data rather than following intent-to-treat principles. Interventions Both interventions consisted of 10 weekly hour-long, in-person group sessions. Main Outcomes and Measures Primary outcomes were feasibility benchmarks, including feasibility of recruitment, treatment arms, assessments, participant retention, racial and ethnic diversity attainment, treatment expectancy, treatment credibility, participant satisfaction, and treatment fidelity. Results Ninety-two participants were randomized to the mind-body walking program (n = 47) or the health education program (n = 45). Participants had a mean (SD) age of 57 (14.3) years; were predominantly females (69 [75.0%]); and included Asian (2.2%), Black or African American (44.6%), Hispanic (5.4%), non-Hispanic (83.7%), and White (40.2%) individuals. Both mind-body walking and health education interventions met the benchmarks for feasibility of treatment arms (95.7% [44 of 46 patients] and 82.2% [37 of 45 patients]), treatment credibility (100% (41 of 41 patients] and 87.2% [34 of 39 patients]), treatment fidelity (9.93 and 9.95 scores), assessment (93.0% accuracy), and participant retention (93.6% [44 of 47 patients] and 86.7% [39 of 45 patients]). Benchmarks for treatment expectancy (85.7% [36 of 42 patients] vs 66.7% [26 of 39 patients]) and participant satisfaction (97.6% [41 of 42 patients] vs 75.0% [30 of 40 patients]) were met in the mind-body walking program but not in the health education program. The racial and ethnic diversity benchmark was met (54.3% [50 of 92] vs >= 38.0% planned). The recruitment benchmark was not met (69.7% [92 of 132] of eligible participants recruited vs >= 80.0% planned). Conclusions and Relevance In this trial, both a mind-body walking program and a health education program were feasible at 3 geographically, racially, and ethnically diverse academic medical centers. The findings support and inform a fully powered, multisite, future efficacy trial of these interventions.

There has been a proliferation in behavioral intervention development due to guidelines recommending their use for managing common, distressing, and interfering symptoms (e.g., insomnia, pain, fatigue) resulting from medical disease (e.g., cancer) and its treatment. Several models of behavioral intervention development exist (e.g., Stage Model, ORBIT). In this review, we focus on the National Institute of Health (NIH) Stage Model for Behavioral Intervention Development because it offers the closest analogue to the formalized drug development process. This review compares the phases of drug development to the six stages of the Stage Model for behavioral intervention development to assist investigators in understanding similarities and differences in terminology (i.e., Phase versus Stage), study designs and methods, and ultimate purpose. Distinguishing features of the NIH Stage Model for behavioral intervention development are highlighted and include: (1) a recursive and iterative flow; and (2) a focus on intervention mechanisms at every stage of development. To illustrate each stage, we refer to a program of research developing and testing a behavioral insomnia and symptom (e.g., pain, fatigue) management intervention for patients with life-threatening hematologic cancer. This illustrative example conveys the initial steps required to develop and pilot test a behavioral intervention before progressing to larger-scale efficacy and effectiveness testing. To conclude, we offer recommendations for investigators designing and testing behavioral interventions. Recommendations are first, develop a long-term research plan that begins with the end in mind, and second, ensure each step in the research plan provides sufficient information to proceed to the next stage.

OBJECTIVES:Insomnia is common for women with breast cancer, and related to fatigue, depression, and pain. Research exploring these symptoms among breast cancer patients in medically underserved areas is lacking. This study aimed to characterize symptom severity, and examine how fatigue, depression, and pain vary based on categories of insomnia severity. METHODS:Women (N = 127) with Stage 0-IV breast cancer receiving care at clinics in mostly rural, medically underserved areas completed self-report measures of insomnia (Insomnia Severity Index), fatigue (PROMIS-Fatigue), depression (Center for Epidemiological Studies Depression Scale), and pain (Brief Pain Inventory). ANOVA or Kruskal-Wallis tests compared differences in fatigue, depression, and pain across insomnia severity categories. Post-hoc tests determined pairwise significant differences. Analyses were conducted using SAS software. RESULTS:Median [IQR] insomnia symptom severity fell within the Subthreshold/Mild range (12.00 [6.00, 16.00]). Thirty-four percent of women endorsed insomnia symptoms in the Moderate range or higher. Median fatigue was moderate (60.80 [55.60, 64.85]), and median depressive symptoms (17.00 [10.50, 23.50]) indicated risk for clinical depression. Mean pain severity (4.59 [1.85]) and median pain interference (4.29 [2.57, 6.46]) were moderate. Women endorsing Subthreshold/Mild and Moderate/Severe insomnia symptoms exhibited significantly worse fatigue, depressive symptoms, and pain. CONCLUSIONS:Results highlight a multi-symptom burden for women with breast cancer receiving care at clinics in medically underserved areas with a largely rural population. Behavioral symptom management is critically needed. Intervening on insomnia may, in turn, improve fatigue, depression, and pain. Behavioral interventions targeting insomnia and related symptoms should be adapted for, and tested, in this population.

Chronic pain is associated with substantial impairment in physical function, which has been identified as a top concern among persons with pain. GetActive-Fitbit, a mind-body activity program, is feasible, acceptable, and associated with improvement in physical function among primarily White, sedentary individuals with pain. In preparation for a multisite efficacy trial, we must examine feasibility across multiple sites with diverse patient populations. Here we describe the protocol of a multisite, feasibility RCT comparing GetActive-Fitbit with a time- and attention-matched educational comparison (Healthy Living for Pain). We aim to 1) test multisite fidelity of clinician training; 2) evaluate multisite feasibility benchmarks, including recruitment of chronic pain patients taking <5,000 steps/day and racial and ethnic minorities; and 3) optimize fidelity and study protocol in preparation for a future multisite efficacy trial. Clinician training fidelity was assessed via roleplays and mock group sessions. Feasibility (i.e., recruitment, acceptability, credibility, adherence, satisfaction), multimodal physical function (e.g., self-report, 6-Minute Walk Test, step-count), and other psychosocial outcomes are assessed at baseline, posttest, and 6 months. Protocol optimization will be assessed using exit interviews and cross-site meetings. The trial is ongoing. Clinician training is complete. 87 participants have been recruited. 54 completed baseline assessments and randomization, 44 are mid-intervention, and 9 have completed the intervention and posttest. This study addresses the critical need for feasible, acceptable mind-body-activity interventions for chronic pain that follow evidence-based guidelines and improve all aspects of physical function across diverse populations. Results will inform a future fully-powered multisite efficacy trial. Funding: NIH/NCCIH 1RO1AT012069-01.

BACKGROUND:Aromatase inhibitors (AIs) are a cornerstone of adjuvant systemic therapy for postmenopausal patients with hormone-receptor positive (HR+) breast cancer. Although AIs decrease cancer recurrence rates and improve survival rates, approximately 50 % of patients experience arthralgia-persistent pain related to worse patient outcomes and poor AI adherence. Current medical interventions for AI-associated arthralgia have limited efficacy and side effects that restrict their use among older patients. OBJECTIVE:The SKIP-Arthralgia trial will test the efficacy of Pain Coping Skills Training (PCST), a cognitive-behavioral therapy (CBT)-informed intervention, delivered via a web-based program called painTRAINER®. PCST and similar CBT-informed pain interventions are efficacious in non-cancer pain and commonly delivered via the Internet, although they have not been tested as a treatment for AI-associated arthralgia. METHODS:452 breast cancer survivors with AI-associated arthralgia will complete a baseline assessment before being randomized to either painTRAINER plus enhanced usual care (EUC; educational materials about AI therapy, arthralgia, and pain), or to EUC alone. Follow-up assessments will occur approximately 2 weeks after the 8- to 10-week intervention period (post-intervention) and at 3- and 6-months post-intervention. Primary outcomes are pain severity and interference at post-intervention. Secondary outcomes include emotional distress, AI adherence, and health-related quality of life. DISCUSSION:This trial aims to fill a gap in evidence-based behavioral pain interventions for breast cancer survivors with AI-associated arthralgia by providing an effective, accessible intervention that could be implemented quickly, including in areas with limited PCST access. If successful, this study could enhance health outcomes for breast cancer survivors on AI therapy and improve adherence to this life-saving medication.