Status:
RECRUITING
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
Lead Sponsor:
Duke University
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief 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 manage...
Eligibility Criteria
Inclusion
- 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
Exclusion
- reported or suspected cognitive impairment confirmed via Folstein Mini-Mental Status Exam \<25;
- 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;
- 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
Key Trial Info
Start Date :
September 11 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT06529120
Start Date
September 11 2025
End Date
June 30 2026
Last Update
September 17 2025
Active Locations (4)
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1
Calvert Health System
Prince Frederick, Maryland, United States, 20678
2
Duke Lifepoint Hospital Maria Parham Medical Center
Henderson, North Carolina, United States, 27536
3
Scotland Health Care System
Laurinburg, North Carolina, United States, 28352
4
UNC Health Johnston
Smithfield, North Carolina, United States, 27577