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

NCT06529120 | Active Not Recruiting

• 2 other identifiers: Pro001160355P30CA014236-50
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 4

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (5)

• Feasibility as measured by study accrual

  Treatment feasibility will be shown by meeting targeted study accrual (N = 15) in 6 months

  6 months of study recruitment

• Feasibility as measured by study attrition

  Treatment feasibility will be shown by no more than 25% study attrition

  12 weeks (post-intervention)

• Feasibility as measured by adherence

  Adherence will be indicated by at least 75% of participants completing all study sessions and assessments

  16 weeks (1-month post-intervention)

• Acceptability as measured by the 10-item Client Satisfaction Questionnaire (CSQ)

  Acceptability will be indicated by at least 80% of the participants reporting satisfaction with the protocol on the CSQ. Items are rated on a 4-point scale from 1 (low) to 4 (high) and averaged to obtain an acceptability score ranging from 1 to 4, with higher scores indicating higher acceptability.

  12 weeks (post-intervention)

• Change in insomnia symptoms

  Insomnia symptoms will be measured using the 7-item Insomnia Symptom Index (ISI). Items are summed to yield a total score ranging from 0 to 28, with higher scores indicating worse insomnia symptoms.

  0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention)

Secondary Outcomes (7)

• Change in fatigue symptoms

  0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention)

• Change in depressive symptoms

  0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention)

• Change in anxiety symptoms

  0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention)

• Change in pain severity

  0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention)

• Change in pain interference

  0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention)

Study Arms (1)

Nite2Day

EXPERIMENTAL

Mindfulness-Based Therapy for Insomnia with Cognitive-Behavioral Symptom Coping Skills (Nite2Day) The Nite2Day intervention will train participants in mindfulness-based sleep strategies and behavioral symptom management techniques. The Nite2Day intervention will consist of 6 weekly sessions that will between 45 and 60 minutes.

Behavioral: Mindfulness-Based Therapy for Insomnia with Cognitive-Behavioral Symptom Coping Skills

Interventions

Mindfulness-Based Therapy for Insomnia with Cognitive-Behavioral Symptom Coping Skills BEHAVIORAL

Mindfulness-based sleep strategies and cognitive-behavioral symptom coping skills.

Nite2Day

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (4)

Calvert Health System

Prince Frederick, Maryland, 20678, United States

Location

Duke Lifepoint Hospital Maria Parham Medical Center

Henderson, North Carolina, 27536, United States

Location

Scotland Health Care System

Laurinburg, North Carolina, 28352, United States

Location

UNC Health Johnston

Smithfield, North Carolina, 27577, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Hannah M Fisher, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2024
• First Posted: July 31, 2024
• Study Start: September 11, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)