To hear about similar clinical trials, please enter your email below
Trial Title:
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
NCT ID:
NCT06529120
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Mindfulness-Based Therapy for Insomnia with Cognitive-Behavioral Symptom Coping Skills
Description:
Mindfulness-based sleep strategies and cognitive-behavioral symptom coping skills.
Arm group label:
Nite2Day
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.
Criteria for eligibility:
Criteria:
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
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
January 1, 2025
Completion date:
June 30, 2025
Lead sponsor:
Agency:
Duke University
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
Duke University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06529120
