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NCT06529120 · ClinicalTrials.gov registry record · 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
A NA study of Breast Cancer, sponsored by Duke University.
- Active
- Registry status
- NA
- Development phase
- 15
- Enrollment target
- 4
- Study locations
NCT06529120: Active NA study of Breast Cancer, sponsored by Duke University.
NCT06529120 is a NA study of Breast Cancer that is active but no longer recruiting, run by Duke University. The registered enrollment target is 15 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (99% lower). The trial reports 4 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06529120, a NA study of Breast Cancer, is active but no longer recruiting, sponsored by Duke University.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 15 participants
- Enrollment target
- 4
- Study locations
Study 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.
Primary Outcome
Treatment feasibility will be shown by meeting targeted study accrual (N = 15) in 6 months
Conditions Studied
Interventions
- BEHAVIORAL Mindfulness-Based Therapy for Insomnia with Cognitive-Behavioral Symptom Coping Skills
Study Locations (4)
North Carolina
- Duke Lifepoint Hospital Maria Parham Medical Center - Henderson
- Scotland Health Care System - Laurinburg
- UNC Health Johnston - Smithfield
Maryland
- Calvert Health System - Prince Frederick
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2025-09-11 |
| Est. Completion | 2026-06-30 |
| Phase | NA |
What the registry record for NCT06529120 still lists
NCT06529120 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 1 intervention - of which Mindfulness-Based Therapy for Insomnia with Cognitive-Behavioral Symptom Coping Skills is the first listed.
NCT06529120 reports a single indexed study location in North Carolina, Maryland.
Frequently Asked Questions
What is clinical trial NCT06529120 about?
NCT06529120 is a clinical study titled "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". 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 min...
What is the current status of trial NCT06529120?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 15 participants. The study started on 2025-09-11. Estimated completion is 2026-06-30.
What conditions does trial NCT06529120 study?
This clinical trial studies the following conditions: Breast Cancer.
What interventions are being tested in trial NCT06529120?
The interventions under investigation include: Mindfulness-Based Therapy for Insomnia with Cognitive-Behavioral Symptom Coping Skills (BEHAVIORAL).
Who is sponsoring clinical trial NCT06529120?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06529120 being conducted?
This trial has 4 study locations across Maryland, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06529120's enrollment target sits among peer trials
15 1144th of 1224 higher than 72 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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