NCT06529120

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
BEHAVIORAL	Mindfulness-Based Therapy for Insomnia with Cognitive-Behavioral Symptom Coping Skills	Mindfulness-based sleep strategies and cognitive-behavioral symptom coping skills.

Timeline

• Start date: 2025-09-11
• Primary completion: 2026-06-30
• Completion: 2026-06-30
• First posted: 2024-07-31
• Last updated: 2026-03-19

Locations

4 sites across 1 country: United States