Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
ACTIVE NOT RECRUITING
NCT06529120
NA

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

View on ClinicalTrials.gov

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

BEHAVIORAL

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