RecruitingNot ApplicableNCT06529120

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

Enrollment

15 participants

Start Date

Sep 11, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is adapting and testing a mindfulness-based program to help women with breast cancer who are struggling with insomnia and other symptoms during treatment. It focuses on women living in rural or underserved areas who may have limited access to in-person care. **You may be eligible if...** - You have been diagnosed with breast cancer (any stage, 0–IV) within the past 12 months - You are 18 years or older - You have at least mild insomnia (difficulty sleeping) - You have a life expectancy of more than 12 months - You can speak and read English **You may NOT be eligible if...** - You were diagnosed with breast cancer more than 12 months ago - You do not have sleep difficulties - You are unable to access telehealth or online sessions - You have another serious medical condition that prevents participation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALMindfulness-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

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NCT06529120


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