Clinical trial NCT06529120: 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
Official 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Breast Cancer
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2024-07-31
Enrollment: 15
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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 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

Primary outcomes:
measure: Feasibility as measured by study accrual
timeFrame: 6 months of study recruitment
measure: Feasibility as measured by study attrition
timeFrame: 12 weeks (post-intervention)
measure: Feasibility as measured by adherence
timeFrame: 16 weeks (1-month post-intervention)
measure: Acceptability as measured by the 10-item Client Satisfaction Questionnaire (CSQ)
timeFrame: 12 weeks (post-intervention)
measure: Change in insomnia symptoms
timeFrame: 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention)
Secondary outcomes:
measure: Change in fatigue symptoms
timeFrame: 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention)
measure: Change in depressive symptoms
timeFrame: 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention)
measure: Change in anxiety symptoms
timeFrame: 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention)
measure: Change in pain severity
timeFrame: 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention)
measure: Change in pain interference
timeFrame: 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention)
measure: Change in mindfulness
timeFrame: 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention)
measure: Change in self-efficacy for symptom management
timeFrame: 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention)
Other outcomes:
Locations:
Study officials:
affiliation: Duke University
name: Hannah M Fisher, PhD
role: PRINCIPAL_INVESTIGATOR
References: