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.

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.

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.

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.