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: Recruiting
Location: See all (4) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• stage 0-IV breast cancer diagnosis within past 12 months

• self-report \>8 on the Insomnia Severity Index, indicating at least mild symptoms of clinical insomnia

• \>18 years old

• life expectancy of \>12 months per medical chart or oncologist

• Ability to speak and read English, and intact hearing and vision

Locations
United States
Maryland
Calvert Health System
RECRUITING
Prince Frederick
North Carolina
Duke Lifepoint Hospital Maria Parham Medical Center
RECRUITING
Henderson
Scotland Health Care System
RECRUITING
Laurinburg
UNC Health Johnston
RECRUITING
Smithfield
Contact Information
Primary
Hannah M Fisher, PhD
hannah.fisher@duke.edu
9194163471
Time Frame
Start Date: 2025-09-11
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 15
Treatments
Experimental: Nite2Day
Mindfulness-Based Therapy for Insomnia with Cognitive-Behavioral Symptom Coping Skills (Nite2Day)~The Nite2Day intervention will train participants in mindfulness-based sleep strategies and behavioral symptom management techniques. The Nite2Day intervention will consist of 6 weekly sessions that will between 45 and 60 minutes.
Related Therapeutic Areas
Sponsors
Leads: Duke University
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov