Adaptation and Pilot Testing of a Mindfulness-Based Insomnia and Symptom Management Intervention for Women With Breast Cancer Receiving Treatment in Rural Medically Underserved Areas
NCT Number: NCT06529120
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Breast Cancer
Interventions: BEHAVIORAL: Mindfulness-Based Therapy for Insomnia with Cognitive-Behavioral Symptom Coping Skills
Sponsor: Duke University
Collaborators: National Cancer Institute (NCI)
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 15
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2025-01-01
Completion Date: 2025-06-30

Summary:
Women with breast cancer often experience multiple difficult symptoms, for example insomnia, fatigue, stress, and pain. This study is being done to test a mindfulness-based insomnia and symptom management intervention for women with breast cancer (Nite2Day). Participants will complete six, 45-60 minute intervention sessions with a study therapist. Intervention sessions will be conducted remotely via conference (i.e., Zoom) or telephone. During these sessions, participants will learn mindfulness and cognitive-behavioral strategies to cope with nighttime sleep disturbances and daytime symptoms of fatigue, stress, and pain. Participants will be asked to complete three, brief (15-20 minute) surveys that will ask questions about their background, cancer diagnosis and treatments, cancer symptoms, and experience with the intervention. Participants will be compensated for completing all intervention sessions and surveys. Total study duration is about 12 weeks.

The greatest risk of this study is loss of confidentiality. Benefits from participating might include learning skills to reduce nighttime sleep disturbances and daytime symptoms of fatigue, stress, and pain. Information learned from this study may also benefit other patients with cancer in the future.

Primary Outcome Measures: Feasibility as measured by study accrual, Treatment feasibility will be shown by meeting targeted study accrual (N = 15) in 6 months, 6 months of study recruitment|Feasibility as measured by study attrition, Treatment feasibility will be shown by no more than 25% study attrition, 12 weeks (post-intervention)|Feasibility as measured by adherence, Adherence will be indicated by at least 75% of participants completing all study sessions and assessments, 16 weeks (1-month post-intervention)|Acceptability as measured by the 10-item Client Satisfaction Questionnaire (CSQ), Acceptability will be indicated by at least 80% of the participants reporting satisfaction with the protocol on the CSQ. Items are rated on a 4-point scale from 1 (low) to 4 (high) and averaged to obtain an acceptability score ranging from 1 to 4, with higher scores indicating higher acceptability., 12 weeks (post-intervention)|Change in insomnia symptoms, Insomnia symptoms will be measured using the 7-item Insomnia Symptom Index (ISI). Items are summed to yield a total score ranging from 0 to 28, with higher scores indicating worse insomnia symptoms., 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention)
Secondary Outcome Measures: Change in fatigue symptoms, Fatigue symptoms will be assessed using the 8-item PROMIS Fatigue Short Form. A raw score is calculated by summing all 8 items, yielding a total raw score that ranges from 8 to 40. The total raw score is then translated to a T-score, which is a standardized score with a mean of 50 and a standard deviation of 10. Higher T-scores indicated higher fatigue., 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention)|Change in depressive symptoms, Depressive symptoms will be assessed using the 8-item PROMIS Depression Short Form. A raw score is calculated by summing all 8 items, yielding a total raw score that ranges from 8 to 40. The total raw score is then translated to a T-score, which is a standardized score with a mean of 50 and a standard deviation of 10. Higher T-scores indicated higher worse depressive symptoms., 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention)|Change in anxiety symptoms, Anxiety symptoms will be assessed using the 8-item PROMIS Anxiety Short Form. A raw score is calculated by summing all 8 items, yielding a total raw score that ranges from 8 to 40. The total raw score is then translated to a T-score, which is a standardized score with a mean of 50 and a standard deviation of 10. Higher T-scores indicated worse anxiety symptoms.., 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention)|Change in pain severity, Pain severity will be assessed using the 11-item Brief Pain Inventory-Short Form (BPI-SF). The BPI-SF consists of 4 items assessing pain severity, including worst, least, average, and current pain in the past week. Responses range from 0 (no pain) to 10 (pain as bad as you can imagine); items are averaged for a composite score that ranges from 0 to 10 with higher scores indicating high pain severity., 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention)|Change in pain interference, Pain interference will be assessed using the 11-item Brief Pain Inventory-Short Form (BPI-SF). The BPI-SF consists of 7 items assessing the degree to which pain has interfered with patients' daily activities in the past week. Responses range from 0 (does not interfere) to 10 (completely interferes); items are averaged for a composite score that ranges from 0 to 10 with higher scores indicating high pain interference., 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention)|Change in mindfulness, Mindfulness will be assessed using the 39-item Five Facet Mindfulness Questionnaire (FFMQ). Items are summed to achieve subscale scores (Observing, Describing, Acting with Awareness, Nonjudging, Nonreactivity). Subscale scores range from 8 to 40, except Nonreactivity, which ranges from 7 to 35. Higher scores indicate higher levels of mindfulness. Subscale scores can be summed to obtain a total FFMQ score that can be divided by 39 to get an average item score ranging from 1 to 5 with higher scores indicating higher total mindfulness., 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention)|Change in self-efficacy for symptom management, Self-efficacy for symptom management will be measured using the Self-Efficacy for Management Chronic Disease measure. Items are scored on a 1 (not at all confident) to 10 (totally confident) scale and averaged to obtain a score that ranges from 1 to 10 with higher scores indicating higher self-efficacy for symptom management.

Scale., 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention)