|

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

RECRUITINGN/ASponsored by Duke University
Actively Recruiting
PhaseN/A
SponsorDuke University
Started2025-09-11
Est. completion2026-06-30
Eligibility
Age18 Years+
SexFEMALE
Healthy vol.Accepted
Locations4 sites

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

Age: 18 Years+Sex: FEMALEHealthy volunteers accepted
Inclusion Criteria:

1. stage 0-IV breast cancer diagnosis within past 12 months
2. self-report \>8 on the Insomnia Severity Index, indicating at least mild symptoms of clinical insomnia
3. \>18 years old
4. life expectancy of \>12 months per medical chart or oncologist
5. Ability to speak and read English, and intact hearing and vision

Exclusion Criteria:

1. reported or suspected cognitive impairment confirmed via Folstein Mini-Mental Status Exam \<25;
2. serious psychiatric (e.g., schizophrenia, suicidal intent) or medical condition (e.g., seizure disorder, narcolepsy, severe or moderate untreated sleep apnea) indicated by self-report, medical chart, or oncologist/provider that would contraindicate safe participation;
3. engagement in behavioral insomnia (e.g., Cognitive-Behavioral Therapy for Insomnia) or symptom management (e.g., Pain Coping Skills Training) interventions within past 6 months

Conditions2

Breast CancerCancer

Locations4 sites

Maryland

1 site
Calvert Health System
Prince Frederick, Maryland, 20678
Hannah M Fisher, PhD

North Carolina

3 sites
Duke Lifepoint Hospital Maria Parham Medical Center
Henderson, North Carolina, 27536
Hannah M Fisher, PhDhannah.fisher@duke.edu
Scotland Health Care System
Laurinburg, North Carolina, 28352
Hannah M Fisher, PhD
UNC Health Johnston
Smithfield, North Carolina, 27577
Hannah M Fisher, PhD

Browse More Trials

Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

This site does not provide medical advice. Always consult your doctor before considering enrollment in a clinical trial. Learn more on our About page.