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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
Sponsor: Duke University
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.
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
15
Start Date
2025-09-11
Completion Date
2026-06-30
Last Updated
2026-03-19
Healthy Volunteers
No
Conditions
Interventions
Mindfulness-Based Therapy for Insomnia with Cognitive-Behavioral Symptom Coping Skills
Mindfulness-based sleep strategies and cognitive-behavioral symptom coping skills.
Locations (4)
Calvert Health System
Prince Frederick, Maryland, United States
Duke Lifepoint Hospital Maria Parham Medical Center
Henderson, North Carolina, United States
Scotland Health Care System
Laurinburg, North Carolina, United States
UNC Health Johnston
Smithfield, North Carolina, United States