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.

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.

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.

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.

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.

Effects of a Weight and Pain Management Program in Patients With Rheumatoid Arthritis With Obesity: A Randomized Controlled Pilot Investigation.

BACKGROUND: Obesity is associated with poor outcomes for patients with rheumatoid arthritis (RA). Effective weight management is imperative. Although traditional lifestyle behavioral weight loss programs have demonstrated efficacy for reducing weight, these interventions do not meet the pain-related weight loss challenges of RA patients with obesity. OBJECTIVE: A 12-session group program (90 minutes per session) was developed integrating pain coping skills training into a lifestyle behavioral weight loss intervention. In addition to the weekly group sessions, participants engaged in supervised exercise sessions 3 times per week. METHODS: Through a small, pilot randomized trial, 50 participants were randomized to receive the intervention (n = 29) or standard care of RA (n = 21). Feasibility data (i.e., accrual, attrition, adherence) was examined using descriptive statistics (e.g., percent). We examined patterns of change in study outcomes from baseline to follow-up separately for the intervention and standard care arms using descriptive statistics and paired t tests. Effect sizes are also presented. RESULTS: Of those randomized to the intervention group,79.3% initiated treatment, with participants attending 74.3% of group skills sessions and 64.2% of exercise sessions. Intervention participants evidenced reductions in weight (mean, -2.28 kg) and waist circumference (mean, -4.76 cm) and improvements in physical functioning, eating behaviors, pain, and self-efficacy for weight control. CONCLUSIONS: Findings suggest that incorporating a combined pain coping skills training and behavioral weight loss intervention into medical management of RA may improve outcomes. Study accrual and attrition, as well as intervention adherence, will inform future, larger randomized efficacy trials of the intervention.Retrospectively registered: January 29, 2020, NCT04246827.

Relationship between social support, physical symptoms, and depression in women with breast cancer and pain.

PURPOSE: Fatigue and pain are common among women with breast cancer, and often related to depressive symptoms. Social support may influence levels of fatigue, pain interference, and depressive symptoms. We tested a theory-based, structural model examining the relationship between social support (i.e., emotional and instrumental) and depressive symptoms via fatigue and pain interference in women with breast cancer. METHODS: Women (N = 327) with stages I-III breast cancer were enrolled in a randomized trial investigating a behavioral pain intervention. Measures of social support, fatigue, pain interference, and depressive symptoms were completed at enrollment. Data were analyzed using structural equation modeling to test direct and indirect pathways relating social support, fatigue, pain interference, and depressive symptoms. RESULTS: Our model evidenced good fit. Significant direct effects emerged linking higher levels of emotional support with lower levels of fatigue (ß = -.30), pain interference (ß = -.32), and depressive symptoms (ß = -.31). More instrumental support was significantly associated with more depressive symptoms (ß = .11), but not fatigue or pain interference. Higher levels of fatigue (ß = .30) and pain interference (ß = .34) were significantly related to higher levels of depressive symptoms. More emotional support related to less depressive symptoms via lower levels of fatigue (ß = -.09) and pain interference (ß = -.11). CONCLUSION: Women reporting higher levels of emotional support endorsed fewer depressive symptoms, and that relationship was driven by lower levels of fatigue and pain interference. Our results highlight novel pathways that healthcare professionals can leverage to optimize social support topics in psychosocial interventions targeting breast cancer symptoms. This model should be replicated using longitudinal data.

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.

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.

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.

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

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