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.

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.

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.

Feasibility of Mobile App-based Coping Skills Training for Cardiorespiratory Failure Survivors: The Blueprint Pilot Randomized Controlled Trial.

Rationale: Psychological distress symptoms are common among patients recently hospitalized with cardiorespiratory failure, yet there are few effective postdischarge therapies that are relevant to their experiences. Objectives: To determine the feasibility and clinical impact of two different versions of a month-long self-guided mobile app-based coping skills program called Blueprint in comparison to usual care (UC) control. Methods: Patients hospitalized with a serious cardiopulmonary diagnoses were recruited from adult intensive care units and stepdown units at a large academic medical center. Participants with elevated psychological distress symptoms just after discharge were randomized in a 1:1:1 ratio to Blueprint with a therapist (BP/therapist), Blueprint without a therapist (BP/no therapist), or UC control. All study procedures were conducted remotely. Blueprint is a self-guided, symptom-responsive, mobile app-based adaptive coping skills program with 4 themed weeks with different daily audio, video, and text content. Participants completed surveys via the app platform at baseline and 1 and 3 months later. The primary outcome was feasibility. Additional outcomes included the HADS (Hospital Anxiety and Depression Scale) total score, the PTSS (Post-Traumatic Stress Scale), and a 100-point quality of life visual analog scale. Results: Of 63 patients who consented, 45 (71%) with elevated distress were randomized to BP/therapist (n = 16 [36%]), BP/no therapist (n = 14 [31%]), and UC (n = 15 [33%]). Observed rates were similar to target feasibility benchmarks, including consented patients who were randomized (71.4%), retention (75.6%), and intervention adherence (97% with weekly use). Estimated mean differences (95% confidence intervals) at 1 month compared with baseline included: HADS total (BP/therapist, -3.8 [-6.7 to -0.6]; BP/no therapist, -4.2 [-7.6 to -0.0]; UC, -3.4 [-6.6 to 0.2]); PTSS (BP/therapist, -6.7 [-11.3 to -2.1]; BP/no therapist, -9.1 [-14.4 to -3.9]; UC, -4.2 [-10.8 to 2.3]); and quality of life (BP/therapist, -4.5 [-14.3 to 4.6]; BP/no therapist, 14.0 [-0.9 to 29.0]; UC, 8.7 [-3.5 to 20.9]). Conclusions: Among survivors of cardiorespiratory failure, a mobile app-based postdischarge coping skills training intervention demonstrated evidence of feasibility and clinical impact compared with UC control. A larger trial is warranted to test the efficacy of this approach. Clinical trial registered with ClinicalTrials.gov (NCT04329702).

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.

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.

Linking physical activity to personal values: feasibility and acceptability randomized pilot of a behavioral intervention for older adults with osteoarthritis pain.

BACKGROUND: Osteoarthritis (OA) pain is common and leads to functional impairment for many older adults. Physical activity can improve OA outcomes for older adults, but few are appropriately active. Behavioral interventions can reduce physical activity barriers. We developed and tested a brief, novel behavioral intervention (i.e., Engage-PA) for older adults combining values to enhance motivation and strategic activity pacing to improve arthritis-related pain and functioning and increase physical activity. METHODS: A randomized feasibility and acceptability pilot trial compared Engage-PA to treatment-as-usual plus fitness tracker (TAU+) in N = 40 adults age 65+ with OA pain in the knee or hip. Engage-PA involved two 60-min telephone sessions. All participants wore a fitness tracker to collect daily steps throughout the study and completed baseline and post-treatment assessments of secondary outcomes (arthritis-related pain and physical functioning, physical activity, psychological distress, psychological flexibility, and valued living). The impact of COVID-19 on general well-being and physical activity was also assessed. Descriptive statistics were conducted for feasibility and acceptability outcomes. Indicators of improvement in secondary outcomes were examined via change scores from baseline to post-treatment and performing independent samples t-tests to assess for between-group differences. RESULTS: Feasibility was high; 100% accrual, low (5%) attrition, and 100% completion of study sessions. Acceptability was high, with 89% finding the intervention "mostly" or "very" helpful. Engage-PA participants demonstrated improvements in arthritis pain severity (Mdiff = 1.68, p = 0.044, 95% CI [- 0.26, 3.62]) and self-reported activity (Mdiff = 0.875, p = 0.038, 95% CI [- 1.85, 0.98]) from baseline to post-treatment as compared to TAU+. Due to pandemic-related challenges, there was a high level of missing data (43%) for daily steps, but available data showed no significant change in steps over time or between the groups. COVID-19 added an additional burden to participants, such that 50% were exercising less, 68% were more sedentary, and 72% lost access to spaces and social support to be active. CONCLUSIONS: Engage-PA is a promising brief, novel behavioral intervention with the potential to support older adults in improving arthritis-related pain and functioning and increasing physical activity. The feasibility and acceptability of Engage-PA are particularly notable as most participants reported COVID-19 added more barriers to physical activity. TRIAL REGISTRATION: ClinicalTrials.gov, NCT04490395 . Registered on July 29, 2020.

Pain, depressive symptoms, and self-efficacy for pain management: examination in African-American women with breast cancer.

PURPOSE: African-American women with breast cancer face significant disparities, including high levels of pain. Depressive symptoms and self-efficacy for pain management impact how women with breast cancer manage pain, yet little is known about how these variables relate to pain specifically for African-American women with breast cancer. METHODS: Baseline linear regression analyses were conducted using a sample of women (n = 98) with stage I-III breast cancer identifying as Black or African-American who were part of a larger intervention trial. Linear regressions explored the effect of depressive symptoms on pain (i.e., severity and interference), and the effect of self-efficacy for pain management on pain. Covariates were age (M = 57.22, SD = 10.76), cancer stage (50% = stage 1), and education level (36% = some college). RESULTS: Participants reported moderate levels of pain severity and interference. Higher depressive symptoms were related to both higher pain severity and interference; (B = 0.06, p < 0.01, 95% CI [0.02,0.09]) and (B = 0.13, p < 0.001, 95% CI [0.09, 0.17]) respectively. Likewise, lower self-efficacy for pain management was also related to both higher pain severity and interference; (B = - 0.04, p < 0.001, 95% CI [- 0.05, - 0.02]) and (B = - 0.06, p < 0.001, 95% CI [- 0.08, - 0.04]) respectively. Women reporting less than a high school diploma endorsed significantly higher pain severity and interference than women reporting some college. Age and cancer stage were not significantly related to pain. CONCLUSION: Pain for African-American women with breast cancer may be influenced by depressive symptoms and self-efficacy for pain management, in addition to other important variables. Attending to better assessment and treatment of depressive symptoms and self-efficacy for pain management may improve outcomes.

Geriatric Assessment Reveals Actionable Impairments in Hematopoietic Stem Cell Transplantation Candidates Age 18 to 80 Years.

Allogeneic hematopoietic stem cell transplantation (HCT) is a potentially curative treatment for both malignant and nonmalignant hematologic diseases; however, reported rates of treatment-related mortality approach 30%. Outcomes are worse in patients who begin HCT with functional impairments. To detect such impairments, a geriatric assessment (GA) is recommended in adults age ≥65 years. Younger HCT candidates also may be impaired because of chemotherapy regimens pre-HCT. Therefore, we hypothesized that GA can be beneficial for adult patients of all ages and subsequently created a clinical pretransplantation optimization program to assess all HCT candidates using a modified GA. One-hundred fifty-seven patients were evaluated in 4 functional domains- physical, cognitive, nutritional, and psychological-at 2 time points prior to HCT-new patient evaluation (NPE) and sign-off (SO)-between October 2017 and January 2020. At NPE, 80.9% of the patients had at least 1 domain with a functional impairment, and physical (P = .006), cognitive (P = .04), and psychological (P = .04) impairments were associated with an increased likelihood of not proceeding to HCT. In addition, patients age 18 to 39 years were more likely than older patients to have a physical function impairment (P = .001). Between NPE and SO, 51.9% of the patients had resolution of 1 or more impairments, and nutritional impairment at SO was predictive of worse overall survival (P = .01). Our study shows that GA can identify functional impairments in patients of all ages. Early identification of impairments could facilitate referrals to supportive care and resolution of impairments prior to HCT, suggesting that GA could be recommended for HCT candidates of all ages.

Designing Psychosocial Intervention Pilot Studies: A Tutorial for Palliative Care Investigators.

This is a tutorial on designing a persuasive pilot study of a psychosocial intervention (e.g., behavioral symptom management) in the palliative care setting. This tutorial is most relevant for early stages of intervention research that aims to progress toward a randomized controlled trial with a high degree of internal validity. Broadly, a pilot study aims to address multiple elements of feasibility and acceptability so that investigators are well positioned for the next study in their program of research. To assist investigators in writing compelling grant applications we designed this tutorial as an annotated checklist of goals that a pilot study within the palliative care domain should seek to accomplish. These goals include the following: 1) begin with the end in mind, 2) use a formal conceptual model, 3) use measures with strong psychometric properties, 4) justify the timing of study sessions and assessments, 5) test recruitment methods, 6) estimate retention, 7) assess interventionist fidelity, 8) assess acceptability of the intervention, 9) assess feasibility, and 10) identify barriers to the next study. We elaborate on these goals by describing an ongoing pilot study testing the feasibility and acceptability of a psychosocial pain management intervention for patients with advanced cancer. Pilot studies are crucial for building a successful program of research, but they are also limited in terms of their sample size and overall objectives. A persuasive pilot study is one that is limited yet useful rather than limited and trivial.

Linking Physical Activity to Personal Values: Feasibility and Acceptability Randomized Pilot of a Behavioral Intervention for Older Adults with Osteoarthritis Pain.

Background Osteoarthritis (OA) pain is common and leads to functional impairment for many older adults. Physical activity can improve OA outcomes for older adults, but few are appropriately active. Behavioral interventions can reduce barriers to physical activity. We developed and tested a brief, novel behavioral intervention for older adults combining values to enhance motivation and strategic activity pacing to improve arthritis-related pain and functioning and increase physical activity. Methods A randomized feasibility and acceptability pilot trial compared Engage-PA to treatment as usual plus fitness tracker (TAU+) in N=40 adults age 65+ with OA pain in the knee or hip. Engage-PA involved two 60-minute telephone sessions. All participants wore a fitness tracker to collect daily steps throughout the study and completed baseline and post-treatment assessments of secondary outcomes (arthritis-related pain and physical functioning, physical activity, psychological distress, psychological flexibility, and value-guided action). The impact of COVID-19 on general wellbeing and physical activity was also assessed. Descriptive statistics were conducted for feasibility and acceptability outcomes. Indicators of improvement in secondary outcomes were examined via change scores from baseline to post-treatment and performing independent samples t -tests to assess for between-group differences. Results Feasibility was high; 100% accrual, low (5%) attrition, and 100% completion of study sessions. Acceptability was high, with 89% finding the intervention "mostly" or "very" helpful. Engage-PA participants demonstrated improvements in arthritis pain severity ( M diff =1.68, p <.05), arthritis-related physical functioning ( M diff =.875, p =.056), and self-reported activity ( M diff =.875, p <.05) from baseline to post-treatment as compared to TAU+. Sixty-three percent of participants provided useable objective daily steps data. Other secondary outcome patterns were not interpretable in this small sample. COVID-19 added additional burden to participants, such that 50% were exercising less, 68% were more sedentary, and 72% lost access to spaces and social support to be active. Conclusions Engage-PA is a promising brief, novel behavioral intervention that has potential to support older adults in improving arthritis-related pain and functioning and increasing physical activity. The feasibility and acceptability of the intervention is particularly notable as most participants reported COVID-19 added more barriers to physical activity, and Engage-PA may be appealing in future studies. Trial Registration: clinicaltrials.gov, NCT04490395, registered 7/29/2020, https://clinicaltrials.gov/ct2/show/NCT04490395.

Virtual reality for improving pain and pain-related symptoms in patients with advanced stage colorectal cancer: A pilot trial to test feasibility and acceptability.

OBJECTIVE: Virtual reality (VR) has the potential to improve pain and pain-related symptoms. We examined the feasibility, acceptability, safety, and impact of a 30-min virtual underwater/sea environment (VR Blue) for reducing pain and pain-related symptoms in advanced colorectal cancer patients. A qualitative exit interview was conducted to understand preferences, thoughts, and feelings about the VR session. METHOD: Participants (N = 20) had stage IV colorectal cancer and moderate-to-severe pain. Participants completed a 30-min VR Blue session that visually and aurally immersed them in virtual ocean scenarios. Feasibility was assessed by accrual (N = 20), protocol adherence (≥80% completing VR Blue), and completed data (≥80% assessment completion). Acceptability was determined by patients reporting ≥80% intervention satisfaction. Safety was determined by ≥80% of patients completing the session without self-reported side effects. Measures of pain, tension, relaxation, stress, anxiety, and mood were collected before, during, and after the VR Blue session. A semi-structured qualitative interview was conducted after VR Blue to assess participants' VR experiences. RESULTS: All participants (100%) completed the VR Blue session. There was 100% data collection at the pre- and post-assessments. Satisfaction with VR Blue was high M = 3.3 (SD = 0.4) (83%). No significant side effects were reported. Pain decreased by 59% (Pre-M = 3 [1]; Post-M = 1 [1]). Tension decreased by 74% (Pre-M = 30 [24]; Post-M = 8 [13]). Relaxation improved by 38% (Pre-M = 62 [21]); Post-M = 86 [17]). Stress decreased by 68% (Pre-M = 24 [24]; Post-M = 8 [14]). Anxiety decreased by 65% (Pre-M = 20 [23]; Post-M = 7 [13]). Mood improved by 70% (Pre-M = 13 [16]; Post-M = 4 [11]). Qualitative data suggested a positive response to the VR Blue protocol. SIGNIFICANCE OF RESULTS: This work supports the feasibility, acceptability, and safety of VR Blue for advanced colorectal cancer patients. Participants showed significant pre-post improvement in pain and pain-related symptoms hinting to the potential feasibility of VR interventions in this population. Larger, randomized trials with a control condition are needed to examine the efficacy of VR-based interventions for patients with advanced colorectal cancer and pain.

Meaning-Centered Pain Coping Skills Training: A Pilot Feasibility Trial of a Psychosocial Pain Management Intervention for Patients with Advanced Cancer.

Background: Pain from advanced cancer can greatly reduce patients' physical, emotional, and spiritual well-being. Objective: To examine the feasibility and acceptability of a behavioral pain management intervention, Meaning-Centered Pain Coping Skills Training (MCPC). Design: This trial used a single-arm feasibility design. Setting/Subjects: Thirty participants with stage IV solid tumor cancer, moderate-to-severe pain, and clinically elevated distress were enrolled from a tertiary cancer center in the United States. The manualized protocol was delivered across four 45- to 60-minute videoconference sessions. Measurements: Feasibility and acceptability were assessed through accrual, session/assessment completion, intervention satisfaction, and coping skills usage. Participants completed validated measures of primary outcomes (i.e., pain severity, pain interference, and spiritual well-being) and secondary outcomes at baseline, post-intervention, and four-week follow-up. Results: Eighty-eight percent (38/43) of patients who completed screening met inclusion criteria, and 79% (30/38) consented and completed baseline assessment. Sixty-seven percent (20/30) of participants were female (mean age = 57). Most participants were White/Caucasian (77%; 23/30) or Black/African American (17%; 5/30) with at least some college education (90%; 27/30). Completion rates for intervention sessions and both post-intervention assessments were 90% (27/30), 87% (26/30), and 77% (23/30), respectively. At the post-intervention assessment, participants reported a high degree of intervention satisfaction (mean = 3.53/4.00; SD = 0.46), and 81% (21/26) reported weekly use of coping skills that they learned. Participants also showed improvement from baseline on all primary outcomes and nearly all secondary outcomes at both post-intervention assessments. Conclusions: MCPC demonstrated strong feasibility and acceptability. Findings warrant further evaluation of MCPC in a randomized controlled trial. ClinicalTrials.gov Identifier: NCT03207360.

Psychosocial impact of proactive rapid genetic counseling following breast cancer diagnosis.

OBJECTIVE: As germline genetic referral becomes increasingly routine as part of the care of newly diagnosed breast cancer patients, it is important to understand the psychosocial impact of genetic counseling at the time of diagnosis. We examined the psychosocial and quality of life (QOL) impact of providing proactive rapid genetic counseling and testing (RGCT) in the immediate aftermath of a breast cancer diagnosis. METHODS: We randomized 330 patients in a 2:1 ratio to proactive rapid genetic counseling (RGCT; N = 222) versus usual care (UC; N = 108). Participants completed a baseline telephone survey before randomization and definitive surgery and a follow-up survey at 1-month post-randomization. We evaluated the impact of RGCT versus UC on breast cancer genetic knowledge, distress, QOL, and decisional conflict. Given that 43% of UC participants and 86% of RGCT participants completed genetic counseling prior to the 1-month assessment, we also evaluated the impact of genetic counseling participation over and above group assignment. RESULTS: The RGCT intervention led to increased breast cancer genetic knowledge relative to UC but did not differentially impact other study outcomes. Across groups patients who participated in genetic counseling had significantly increased knowledge and improved QOL compared to those who did not participate in genetic counseling. CONCLUSIONS: While prior research has documented the impact of genetic counseling and testing on surgical decisions, these results confirm that participation in genetic counseling at the time of diagnosis can yield improvements in knowledge and QOL in the short-term.