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Completed Not applicable Interventional

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

ClinicalTrials.gov ID: NCT06529120

Public ClinicalTrials.gov record NCT06529120. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 7, 2026, 7:25 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT06529120
Recruitment status
Completed
Study type
Interventional
Phase
Not applicable
Lead sponsor
Duke University
Other
Enrollment
15 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
Female
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Sep 10, 2025
Primary completion
Jun 1, 2026
Completion
Jun 1, 2026
Last update posted
Jul 7, 2026

2025 – 2026

United States locations

U.S. sites
4
U.S. states
2
U.S. cities
4
Facility City State ZIP Site status
Calvert Health System Prince Frederick Maryland 20678
Duke Lifepoint Hospital Maria Parham Medical Center Henderson North Carolina 27536
Scotland Health Care System Laurinburg North Carolina 28352
UNC Health Johnston Smithfield North Carolina 27577

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT06529120, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jul 7, 2026 · Synced Sep 7, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT06529120 live on ClinicalTrials.gov.

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