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 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.

Study Overview

• Status: Active, not recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Behavioral: Mindfulness-Based Therapy for Insomnia with Cognitive-Behavioral Symptom Coping Skills

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Prince Frederick, Maryland, United States, 20678
      • Calvert Health System
  • North Carolina
    • Henderson, North Carolina, United States, 27536
      • Duke Lifepoint Hospital Maria Parham Medical Center
    • Laurinburg, North Carolina, United States, 28352
      • Scotland Health Care System
    • Smithfield, North Carolina, United States, 27577
      • UNC Health Johnston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nite2Day; 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; Mindfulness-based sleep strategies and cognitive-behavioral symptom coping skills.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
Acceptability as measured by the 8-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 summed to obtain an acceptability score ranging from 8 to 32, with higher scores indicating higher acceptability.	12 weeks (post-intervention)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in fatigue symptoms	Fatigue symptoms will be assessed using the 8-item PROMIS Fatigue Short Form. A raw score is calculated by summing all 8 items, yielding a total raw score that ranges from 8 to 40. The total raw score is then translated to a T-score, which is a standardized score with a mean of 50 and a standard deviation of 10. Higher T-scores indicated higher fatigue.	0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention)
Change in pain severity	Pain severity will be assessed using the 11-item Brief Pain Inventory-Short Form (BPI-SF). The BPI-SF consists of 4 items assessing pain severity, including worst, least, average, and current pain in the past week. Responses range from 0 (no pain) to 10 (pain as bad as you can imagine); items are averaged for a composite score that ranges from 0 to 10 with higher scores indicating high pain severity.	0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention)
Change in pain interference	Pain interference will be assessed using the 11-item Brief Pain Inventory-Short Form (BPI-SF). The BPI-SF consists of 7 items assessing the degree to which pain has interfered with patients' daily activities in the past week. Responses range from 0 (does not interfere) to 10 (completely interferes); items are averaged for a composite score that ranges from 0 to 10 with higher scores indicating high pain interference.	0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention)
Change in depressive symptoms	Depressive symptoms will be assessed using the 8-item PROMIS Depression Short Form. A raw score is calculated by summing all 8 items, yielding a total raw score that ranges from 8 to 40. The total raw score is then translated to a T-score, which is a standardized score with a mean of 50 and a standard deviation of 10. Higher T-scores indicate higher worse depressive symptoms.	0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention)
Change in anxiety symptoms	Anxiety symptoms will be assessed using the 8-item PROMIS Anxiety Short Form. A raw score is calculated by summing all 8 items, yielding a total raw score that ranges from 8 to 40. The total raw score is then translated to a T-score, which is a standardized score with a mean of 50 and a standard deviation of 10. Higher T-scores indicate worse anxiety symptoms.	0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention)
Change in mindfulness	Mindfulness will be assessed using the 10-item Cognitive and Affective Mindfulness Scale - Revised (CAMS-R). Items are summed to achieve a total score ranging from 10 to 40. Higher scores indicate higher levels of mindfulness.	0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention)
Change in self-efficacy for symptom management	Self-efficacy for symptom management will be measured using the 8-item PROMIS Self-Efficacy for Managing Chronic Conditions (Managing Symptoms) measure. A raw score is calculated by summing all 8 items, yielding a total raw score that ranges from 8 to 40. The total raw score is then translated to a T-score, which is a standardized score with a mean of 50 and a standard deviation of 10. Higher T-scores indicate higher self-efficacy for managing chronic conditions (managing symptoms).	0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention)

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Hannah M Fisher, PhD, Duke University

Study record dates

Study Major Dates

• Study Start (Actual): September 11, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: July 26, 2024
• First Submitted That Met QC Criteria: July 26, 2024
• First Posted (Actual): July 31, 2024

Study Record Updates

• Last Update Posted (Actual): June 10, 2026
• Last Update Submitted That Met QC Criteria: June 8, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms
• Other Study ID Numbers: Pro00116035; 5P30CA014236-50 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No