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.

Mindful Night-to-Day: A Pilot Feasibility Trial of a Mindfulness-Based Insomnia and Symptom Management Intervention for Patients with Hematologic Cancer.

OBJECTIVES: Patients with hematologic cancer experience severe symptoms (i.e. insomnia, fatigue, pain, distress). Few interventions addressing insomnia and other symptoms exist for this population. Mindfulness-Based Therapy for Insomnia (MBTI) may be appropriate but has only been tested in healthy outpatients. This study aimed to develop and test an adapted MBTI protocol for hematologic cancer patients. METHODS: Patient (n = 3) and clinician (n = 1) focus groups, and user-testing (N = 5) informed adaptation of Mindful Night-to-Day (MBTI+). A single-arm pilot trial (N = 32) evaluated feasibility (accrual, attrition, adherence), acceptability (intervention satisfaction), and changes to insomnia symptom severity (Insomnia Severity Index; primary outcome) and secondary outcomes (fatigue, pain, distress, pre-sleep arousal, mindfulness, symptom management self-efficacy) at baseline, post-intervention, and 1-month post-intervention. Descriptive statistics and paired sample t-tests were conducted. RESULTS: Qualitative feedback informed MBTI+ content, format, and delivery. Mindfulness was used to increase symptom awareness (sleepiness vs. fatigue). Meditations and behavioral skills were applied to inpatient treatment. MBTI+ met feasibility (N = 32/12 months; 8.1% attrition; 83.8% adherence) and acceptability (M = 3.52/4.00) benchmarks. Insomnia symptom severity decreased (d = 1.20) from baseline to post-intervention, as did most secondary outcomes. CONCLUSIONS: MBTI+ was feasible, acceptable, and showed promise for benefits throughout inpatient and outpatient treatment. Findings warrant further evaluation in a randomized trial.

Overcoming Patient Pain Together: Breast Cancer Patients and Caregivers' Pretreatment Psychosocial Distress Linked to Patients' Pain Interference During the First Year of Treatment.

Breast cancer patients experience treatment-related pain from surgery, radiation, chemotherapy, and long-term hormonal treatment, which can lead to poorer outcomes. Patient and family caregivers' psychosocial distress exacerbates patient pain interference, but this has not been directly examined among breast cancer patients in dyadic models longitudinally. Guided by a biopsychosocial framework, the Biobehavioral Family Model, we explore how multiple reports of patient pain interference across the first year of treatment are linked to the patient (N = 55) and caregiver (N = 55) pretreatment psychosocial distress (eg, depression, anxiety, marital satisfaction, family relationship quality). Specifically, we find that breast cancer patients' pain interference increases and then decreases over the first year of treatment. Additionally, caregivers' pretreatment anxiety was associated with increased patient pain interference over time (B = .19, SE = .07, P = .008), while patients' pretreatment psychosocial distress was not associated with a change in their pain interference. Yet, looking at clinically specific times during the first year of treatment, we find that caregiver-reported higher marital satisfaction is associated with lower patient-reported pain interference later in treatment (6 months: B = -.58, SE = .24, P = .017; 12 months: B = -.82, SE = .23, P < .001). We conclude that, per the Biobehavioral Family Model, pretreatment patient and caregiver psychosocial distress is linked to patient pain interference during the first year of breast cancer treatment. Thus, caregivers' psychosocial distress (ie, anxiety and marital satisfaction) may be a particularly important target in future dyadic behavioral intervention strategies to reduce breast cancer patient pain. PERSPECTIVE: This article presents the link between breast cancer patients and family caregiver pretreatment psychosocial distress (anxiety, depression, marital satisfaction, and family quality) on patient pain interference during 1 year of breast cancer treatment. Findings suggest that caregiver anxiety and marital satisfaction may be important targets for future dyadic behavioral pain interventions.

Improving multimodal physical function in adults with heterogeneous chronic pain; Protocol for a multisite feasibility RCT.

BACKGROUND: 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 <5000 steps/day and racial and ethnic minorities; and 3) optimize fidelity and study protocol in preparation for a future multisite efficacy trial. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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. CLINICAL TRIAL REGISTRATION: NCT05700383.

Managing Chronic Pain in Cancer Survivorship: Communication Challenges and Opportunities as Described by Cancer Survivors.

OBJECTIVES: Many cancer survivors experience chronic pain after completing curative-intent treatment. Based on available data, chronic pain may be undertreated in this context; however, little is known about cancer survivors' experiences with clinical management of chronic pain. The purpose of this study was to better understand cancer survivors' pain management experiences after curative-intent treatment. METHODS: We conducted 13 semi-structured interviews with a convenience sample of cancer survivors who had completed treatment for stage I-III breast, head/neck, lung or colorectal cancer. We used a thematic approach to qualitative data analysis. RESULTS: Participants described that chronic pain often goes unrecognized by their providers, potentially due to limitations in how pain is assessed clinically and the tendency of both cancer survivors and providers to minimize or invalidate the pain experience. To improve communication, participants suggested that providers ask more open-ended questions about their pain, help them to establish functional goals, and provide patients with options for pain management. SIGNIFICANCE OF RESULTS: This study demonstrates the importance of provider-initiated communication around pain management for cancer survivors to make them feel more supported in their care. Communication and shared decision-making interventions may improve cancer survivor-provider communication around chronic pain management, addressing an important gap in survivorship care.

Expressive writing to address distress in hospitalized adults with acute myeloid leukemia: a pilot randomized clinical trial.

PURPOSE: Patients with acute myeloid leukemia (AML) experience significant distress. Expressive writing is an intervention designed to improve well-being by encouraging expression of emotions related to traumatic experiences. Expressive writing has been shown to be generally feasible and effective at improving the cancer experience but has not been examined in patients with recently diagnosed hematologic malignancies. We examined the feasibility of an expressive writing intervention for hospitalized patients with AML receiving induction chemotherapy. METHODS: Fifteen hospitalized AML patients were randomized to complete expressive writing or neutral prompts. Feasibility was defined as 80% of enrolled subjects completing the study. Participants completed validated questionnaires measuring depression, anxiety, resilience, rumination, and quality of life at baseline, completion of the second and fourth writing exercises, and 3 months after enrollment. Participants also completed post-writing surveys following the writing exercise to reflect on the experience. FINDINGS: We enrolled 15 participants and 8 of 15 subjects (53%) completed the study. Due to low enrollment, we examined the pre-to-post intervention changes, rather than comparing results across intervention arms. Pre-to-post intervention changes in the expected direction were seen at the second assessment for depression and resilience, at the fourth assessment for rumination, emotional well-being, and social well-being, and at the 3-month follow-up for anxiety and emotional well-being. Similar changes in patient-reported outcomes were also seen in the control condition. Participants who completed the intervention reported the experience was meaningful and were able to express their deepest thoughts and feelings, more so than participants in the control arm. CONCLUSION: In our work, the expressive writing intervention was not found to be feasible. The trial was interrupted by the COVID-19 pandemic which likely impacted the feasibility. Future studies should aim to identify ways to make the intervention more accessible, such as developing an electronic application for expressive writing.

Meaning-centered pain coping skills training for patients with metastatic cancer: Protocol for a randomized controlled efficacy trial.

BACKGROUND: Many patients with advanced cancer describe pain as a debilitating symptom that greatly interferes with daily activities and enjoyment of life. Psychosocial interventions can improve cancer-related pain but rarely address spiritual concerns (e.g., loss of meaning, peace), which can influence the pain experience for those facing life-threatening illness. To address these needs, we systematically developed and pilot tested a novel psychosocial intervention called Meaning-Centered Pain Coping Skills Training (MCPC). In this randomized controlled trial, we aim to determine MCPC's efficacy for reducing pain interference (primary outcome) and improving secondary outcomes. We will also estimate MCPC's cost-effectiveness. METHOD/DESIGN: Patients (target N = 210) with advanced solid tumor malignancies (Stage IV) and clinically-elevated pain interference will be enrolled and block randomized with equal allocation to MCPC + enhanced usual care or enhanced usual care alone. MCPC's four, videoconferenced, 45-60 min weekly sessions will be individually delivered by trained study therapists. Primary (pain interference) and secondary (pain severity, anxiety and depressive symptoms, pain self-efficacy, social support, spiritual well-being) patient-reported outcomes will be assessed at baseline, and 8-weeks (primary endpoint) and 12-weeks after baseline. CONCLUSION: Our MCPC intervention is the first to systematically address the biopsychosocial-spiritual aspects of pain in patients with advanced cancer. If MCPC demonstrates efficacy, next steps will involve hybrid efficacy-effectiveness and implementation work to broaden access to this brief, manualized, remotely-delivered intervention, with the goal of reducing suffering in patients with life-threatening illness.

Breast cancer survivors with pain: an examination of the relationships between body mass index, physical activity, and symptom burden.

PURPOSE: Overweight and obesity are common for breast cancer survivors and associated with high symptom burden (i.e., pain, fatigue, depressive symptoms). Physical activity may protect breast cancer survivors with higher body mass indexes (BMI) from increased symptoms. However, the role of physical activity in buffering the relationship between higher BMI and greater symptoms is unclear. METHODS: Baseline data from a randomized trial investigating Pain Coping Skills Training among breast cancer survivors (N = 327) with pain were used to examine the relationship between self-reported BMI (kg/m2) and physical activity level (Rapid Assessment of Physical Activity; suboptimal vs. optimal) with pain (Brief Pain Inventory; severity and interference), fatigue (PROMIS-Fatigue short form), and depressive symptoms (Center for Epidemiological Studies Depression Scale). Analyses were conducted in SPSS. Hayes PROCESS macro (Model 1) assessed whether physical activity moderated the relationship between BMI and symptoms. RESULTS: Lower BMI (B = .06, p < .01) and optimal physical activity (B = - .69, p < .01) were independently associated with lower pain interference. Lower BMI was also associated with lower pain severity (B = .04, p < .001). Neither BMI nor physical activity was associated with fatigue or depressive symptoms. Physical activity did not moderate the relationship between BMI and symptoms. CONCLUSIONS: Among breast cancer survivors experiencing pain, higher BMI and being less physically active were related to greater pain (i.e., severity and/or interference). Physical activity did not buffer the relationships between BMI and pain, fatigue, and depressive symptoms, suggesting that physical activity alone may not be sufficient to influence the strength of the relationships between BMI and symptoms.

Patterns of patient-reported symptoms and association with sociodemographic and systemic sclerosis disease characteristics: a scleroderma Patient-centered Intervention Network (SPIN) Cohort cross-sectional study.

Background: Systemic sclerosis is a heterogenous disease in which little is known about patterns of patient-reported symptom clusters. We aimed to identify classes of individuals with similar anxiety, depression, fatigue, sleep disturbance, and pain symptoms and to evaluate associated sociodemographic and disease-related characteristics. Methods: This multi-centre cross-sectional study used baseline data from Scleroderma Patient-centered Intervention Network Cohort participants enrolled from 2014 to 2020. Eligible participants completed the PROMIS-29 v2.0 measure. Latent profile analysis was used to identify homogeneous classes of participants based on patterns of anxiety, depression, fatigue, sleep disturbance, and pain scores. Sociodemographic and disease-related characteristics were compared across classes. Findings: Among 2212 participants, we identified five classes, including four classes with "Low" (565 participants, 26%), "Normal" (651 participants, 29%), "High" (569 participants, 26%), or "Very High" (193 participants, 9%) symptom levels across all symptoms. Participants in a fifth class, "High Fatigue/Sleep/Pain and Low Anxiety/Depression" (234 participants, 11%) had similar levels of fatigue, sleep disturbance, and pain as in the "High" class but low anxiety and depression symptoms. There were significant and substantive trends in sociodemographic characteristics (age, education, race or ethnicity, marital or partner status) and increasing disease severity (diffuse disease, tendon friction rubs, joint contractures, gastrointestinal symptoms) across severity-based classes. Disease severity and sociodemographic characteristics of "High Fatigue/Sleep/Pain and Low Anxiety/Depression" class participants were similar to the "High" severity class. Interpretation: Most people with systemic sclerosis can be classified by levels of patient-reported symptoms, which are consistent across symptoms and highly associated with sociodemographic and disease-related variables, except for one group which reports low mental health symptoms despite high levels of other symptoms and substantial disease burden. Studies are needed to better understand resilience in systemic sclerosis and to identify and facilitate implementation of cognitive and behavioural strategies to improve coping and overall quality of life. Funding: National Institute of Nursing Research (F31NR019007), Canadian Institutes of Health Research, Arthritis Society Canada, the Lady Davis Institute for Medical Research, the Jewish General Hospital Foundation, McGill University, Scleroderma Society of Ontario, Scleroderma Canada, Sclérodermie Québec, Scleroderma Manitoba, Scleroderma Atlantic, Scleroderma Association of BC, Scleroderma SASK, Scleroderma Australia, Scleroderma New South Wales, Scleroderma Victoria, and Scleroderma Queensland.

Nurse-led interventions in systemic autoimmune rheumatic diseases: a systematic review.

BACKGROUND: Nurses play an important role in the management of patients with systemic autoimmune rheumatic diseases. Little is known about the effectiveness of nurse-led interventions on patient-reported outcomes in this population. The aim of this systematic review was to examine the evidence of nurse-led interventions in systemic autoimmune rheumatic diseases. METHODS: Using the Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines, a comprehensive literature search was conducted in PubMed, Cumulative Index to Nursing and Allied Health Literature, PsycINFO, and Embase for studies published from database inception to September 2022. Studies were included if they were published in a peer-reviewed journal in English and evaluated the effectiveness of a nurse-led intervention using a randomized controlled trial design in adults with a systemic autoimmune rheumatic disease. Screening, full-text review, and quality appraisal were conducted by two independent reviewers. RESULTS: A total of 162 articles were identified for possible inclusion, of which five studies were included. Four of five studies (80%) were conducted in systemic lupus erythematosus. There was significant variability in the types of nurse-led interventions; the majority included educational sessions and follow up counseling by a nurse (n = 4). The most common patient-reported outcomes were health-related quality of life (n = 3), fatigue (n = 3), mental health (including anxiety and depression) (n = 2), and self-efficacy (n = 2). The duration of the interventions varied from 12 weeks to 6 months. All studies included a nurse with specialized training and education and showed significant improvements in their primary outcomes. The majority of the studies (60%) were considered high methodological quality. CONCLUSION: This systematic review provides emerging evidence for the use of nurse-led interventions in systemic autoimmune rheumatic diseases. Our findings emphasize the important role of nurses in providing nonpharmacological strategies to help patients better manage their disease and improve health outcomes.

Cost-Effectiveness Analysis Evaluating Delivery Strategies for Pain Coping Skills Training in Women With Breast Cancer.

Pain coping skills training (PCST) is efficacious in patients with cancer, but clinical access is limited. To inform implementation, as a secondary outcome, we estimated the cost-effectiveness of 8 dosing strategies of PCST evaluated in a sequential multiple assignment randomized trial among women with breast cancer and pain (N = 327). Women were randomized to initial doses and re-randomized to subsequent doses based on their initial response (ie, ≥30% pain reduction). A decision-analytic model was designed to incorporate costs and benefits associated with 8 different PCST dosing strategies. In the primary analysis, costs were limited to resources required to deliver PCST. Quality-adjusted life-years (QALYs) were modeled based on utility weights measured with the EuroQol-5 dimension 5-level at 4 assessments over 10 months. A probabilistic sensitivity analysis was performed to account for parameter uncertainty. Implementation of PCST initiated with the 5-session protocol was more costly ($693-853) than strategies initiated with the 1-session protocol ($288-496). QALYs for strategies beginning with the 5-session protocol were greater than for strategies beginning with the 1-session protocol. With the goal of implementing PCST as part of comprehensive cancer treatment and with willingness-to-pay thresholds ranging beyond $20,000 per QALY, the strategy most likely to provide the greatest number of QALYs at an acceptable cost was a 1-session PCST protocol followed by either 5 maintenance telephone calls for responders or 5 sessions of PCST for nonresponders. A PCST program with 1 initial session and subsequent dosing based on response provides good value and improved outcomes. PERSPECTIVE: This article presents the results of a cost analysis of the delivery of PCST, a nonpharmacological intervention, to women with breast cancer and pain. Results could potentially provide important cost-related information to health care providers and systems on the use of an efficacious and accessible nonmedication strategy for pain management. TRIALS REGISTRATION: ClinicalTrials.gov: NCT02791646, registered 6/2/2016.

Meaning-centered pain coping skills training for patients with metastatic cancer: Results of a randomized controlled pilot trial.

OBJECTIVE: For patients with advanced cancer, pain is a common and debilitating symptom that can negatively impact physical, emotional, and spiritual well-being. This trial examined the feasibility and initial effects of Meaning-Centered Pain Coping Skills Training (MCPC), a cognitive-behavioral pain management intervention with an emphasis on enhancing meaning (i.e., a personal sense of purpose, worth, and significance) and peace. METHODS: We enrolled 60 adults with stage IV solid tumor cancers and moderate-severe pain between February 2021 and February 2022. Participants were randomized 1:1 to MCPC + usual care or usual care alone. Meaning-Centered Pain Coping Skills Training consisted of four weekly 60-min individual sessions via videoconference or telephone, delivered by a trained therapist using a manualized protocol. Participants completed validated measures of pain severity, pain interference, pain self-efficacy, spiritual well-being (i.e., meaning, peace, and faith), and psychological distress at baseline and 5-week and 10-week follow-ups. RESULTS: All feasibility metrics exceeded prespecified benchmarks. Fifty-eight percent of screened patients were eligible, and 69% of eligible patients consented. Of those assigned to MCPC, 93% completed all sessions and 100% of those who completed follow-ups reported using coping skills weekly. Retention was strong at 5-week (85%) and 10-week (78%) follow-ups. Meaning-Centered Pain Coping Skills Training participants reported better scores than control participants across outcome measures, including moderate-to-large sized differences at 10-week follow-up in pain severity (Cohen's d = -0.75 [95% confidence interval: -1.36, -0.14]), pain interference (d = -0.82 [-1.45, -0.20]), and pain self-efficacy (d = 0.74 [0.13, 1.35]). CONCLUSIONS: MCPC is a highly feasible, engaging, and promising approach for improving pain management in advanced cancer. Future efficacy testing is warranted. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04431830, registered 16 June 2020.

Effect of Pain Coping Skills Training on Pain and Pain Medication Use for Women With Breast Cancer.

CONTEXT: Pain is distressing for women with breast cancer. Pain medication may not provide full relief and can have negative side-effects. Cognitive-behavioral pain intervention protocols reduce pain severity and improve self-efficacy for pain management. These interventions' impact on pain medication use is less clear. Intervention length and coping skills use might play a role in pain outcomes. OBJECTIVES: Secondary analysis to examine differences in pain severity, pain medication use, pain self-efficacy, and coping skill use after five- and one-session cognitive-behavioral pain intervention protocols. Pain self-efficacy and coping skills use were assessed as mediators of intervention effects on pain and pain medication use. METHODS: Women (N = 327) with stage I-III breast cancer were enrolled in a randomized trial comparing individually-delivered, five- and one-session pain coping skills training (PCST). Pain severity, pain medication use, pain self-efficacy, and coping skills use were assessed preintervention and five to eight weeks later (postintervention). RESULTS: Pain and pain medication use significantly decreased, while pain self-efficacy increased pre-post for women randomized to both conditions (P's <.05). Five-session PCST participants demonstrated less pain (P =.03) and pain medication use (P =.04), and more pain self-efficacy (P =.02) and coping skills use (P =.04) at postintervention compared to one-session PCST participants. Pain self-efficacy mediated the relationship of intervention condition with pain and pain medication use. CONCLUSION: Both conditions led to improvements in pain, pain medication use, pain self-efficacy, and coping skills use, and 5-session PCST showed the greatest benefits. Brief cognitive-behavioral pain intervention improve pain outcomes, and pain self-efficacy may play a role in these effects.

mHealth Coping Skills Training for Symptom Management (mCOPE) for colorectal cancer patients in early to mid-adulthood: Study protocol for a randomized controlled trial.

Background: Colorectal cancer (CRC) patients in early to mid-adulthood (≤50 years) are challenged by high symptom burden (i.e., pain, fatigue, distress) and age-related stressors (e.g., managing family, work). Cognitive behavioral theory (CBT)-based coping skills training interventions reduce symptoms and improve quality of life in cancer patients. However, traditional CBT-based interventions are not accessible to these patients (e.g., in-person sessions, during work day), nor designed to address symptoms within the context of this stage of life. We developed a mobile health (mHealth) coping skills training program for pain, fatigue and distress (mCOPE) for CRC patients in early to mid-adulthood. We utilize a randomized controlled trial to test the extent to which mCOPE reduces pain, fatigue and distress (multiple primary outcomes) and improves quality of life and symptom self-efficacy (secondary outcomes). Methods/Design: Patients (N = 160) ≤50 years with CRC endorsing pain, fatigue and/or distress are randomized 1:1 to mCOPE or standard care. mCOPE is a five-session CBT-based coping skills training program (e.g., relaxation, activity pacing, cognitive restructuring) that was adapted for CRC patients in early to mid-adulthood. mCOPE utilizes mHealth technology (e.g., videoconference, mobile app) to deliver coping skills training, capture symptom and skills use data, and provide personalized support and feedback. Self-report assessments are completed at baseline, post-treatment (5-8 weeks post-baseline; primary endpoint), and 3- and 6-months later. Conclusions: mCOPE is innovative and potentially impactful for CRC patients in early to mid-adulthood. Hypothesis confirmation would demonstrate initial efficacy of a mHealth cognitive behavioral intervention to reduce symptom burden in younger CRC patients.

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.

Role of self-efficacy for pain management and pain catastrophizing in the relationship between pain severity and depressive symptoms in women with breast cancer and pain.

PURPOSE: This study evaluated the relationship between pain and depressive symptoms through pain self-efficacy and pain catastrophizing in breast cancer patients with pain. DESIGN: Secondary analysis of a randomized trial investigating a cognitive-behavioral pain management protocol. SAMPLE: Females (N = 327) with stage I-III breast cancer and report of at least moderate pain. METHODS: Pain severity, pain self-efficacy, pain catastrophizing, and depressive symptoms were measured. The proposed model was assessed using structural equation modeling. RESULTS: Higher pain severity was significantly related to lower pain self-efficacy and higher pain catastrophizing. Lower pain self-efficacy and higher pain catastrophizing were significantly related to more depressive symptoms. Higher pain severity was significantly associated with more depressive symptoms through lower pain self-efficacy and higher pain catastrophizing. The association between pain severity and depressive symptoms was not significant when specified as a direct effect. CONCLUSION: Pain severity related to depressive symptoms in breast cancer patients via pain self-efficacy and pain catastrophizing. IMPLICATIONS FOR PSYCHOSOCIAL PROVIDERS: Measurement of pain self-efficacy and pain catastrophizing should be incorporated into comprehensive pain assessments for women with breast cancer, as these variables may be relevant therapeutic targets. Psychosocial symptom management interventions should include strategies that increase pain self-efficacy and decrease pain catastrophizing because these pain-related cognitive variables appear to drive the relationship between pain severity and depressive symptoms.

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.

Hybrid-delivered cognitive behavioral symptom management and activity coaching intervention for patients undergoing hematopoietic stem cell transplant: Findings from intervention development and a pilot randomized trial.

OBJECTIVE: Develop and pilot test a mobile health (mHealth) cognitive behavioral coping skills training and activity coaching protocol (HCT Symptoms and Steps) for hematopoietic stem cell transplant (HCT) patients. DESIGN: Two-phase, mixed methods study. SAMPLE: HCT patients and healthcare providers. METHODS: Phase I was patient (n = 5) and provider (n = 1) focus groups and user testing (N = 5) to develop the HCT Symptoms and Steps protocol. Phase II was a pilot randomized trial (N = 40) to evaluate feasibility, acceptability, and pre-to-post outcomes (e.g., physical disability, pain, fatigue, distress, physical activity, symptom self-efficacy) compared to an education control. FINDINGS: Qualitative feedback on symptoms, recruitment strategies, coping skills, and mHealth components (e.g., Fitbit, mobile app) were integrated into the protocol. HCT Symptoms and Steps were feasible and acceptable. Pre-post changes suggest physical disability and activity improved while symptoms (e.g., fatigue, distress) decreased. CONCLUSIONS: HCT Symptoms and Steps have strong feasibility and acceptability and shows promise for benefits. Larger, fully-powered randomized trials are needed to examine intervention efficacy. IMPLICATIONS: HCT Symptoms and Steps may reduce physical disability and improve health outcomes post-transplant. CLINICAL TRIAL REGISTRATION NUMBER: NCT03859765.

A Framework for Automating Psychiatric Distress Screening in Ophthalmology Clinics Using an EHR-Derived AI Algorithm.

Purpose: In patients with ophthalmic disorders, psychosocial risk factors play an important role in morbidity and mortality. Proper and early psychiatric screening can result in prompt intervention and mitigate its impact. Because screening is resource intensive, we developed a framework for automating screening using an electronic health record (EHR)-derived artificial intelligence (AI) algorithm. Methods: Subjects came from the Duke Ophthalmic Registry, a retrospective EHR database for the Duke Eye Center. Inclusion criteria included at least two encounters and a minimum of 1 year of follow-up. Presence of distress was defined at the encounter level using a computable phenotype. Risk factors included available EHR history. At each encounter, risk factors were used to discriminate psychiatric status. Model performance was evaluated using area under the receiver operating characteristic (ROC) curve and area under the precision-recall curve (PR AUC). Variable importance was presented using odds ratios (ORs). Results: Our cohort included 358,135 encounters from 40,326 patients with an average of nine encounters per patient over 4 years. The ROC and PR AUC were 0.91 and 0.55, respectively. Of the top 25 predictors, the majority were related to existing distress, but some indicated stressful conditions, including chemotherapy (OR = 1.36), esophageal disorders (OR = 1.31), central pain syndrome (OR = 1.25), and headaches (OR = 1.24). Conclusions: Psychiatric distress in ophthalmology patients can be monitored passively using an AI algorithm trained on existing EHR data. Translational Relevance: When paired with an effective referral and treatment program, such algorithms may improve health outcomes in ophthalmology.

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.