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

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2025-09-11
Study Completion:2026-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06529120

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. stage 0-IV breast cancer diagnosis within past 12 months
  2. 2. self-report \>8 on the Insomnia Severity Index, indicating at least mild symptoms of clinical insomnia
  3. 3. \>18 years old
  4. 4. life expectancy of \>12 months per medical chart or oncologist
  5. 5. Ability to speak and read English, and intact hearing and vision
  1. 1. reported or suspected cognitive impairment confirmed via Folstein Mini-Mental Status Exam \<25;
  2. 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. 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

Contacts and Locations

Study Contact

Hannah M Fisher, PhD
CONTACT
9194163471
hannah.fisher@duke.edu

Principal Investigator

Hannah M Fisher, PhD
PRINCIPAL_INVESTIGATOR
Duke University

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Duke University

  • Hannah M Fisher, PhD, PRINCIPAL_INVESTIGATOR, Duke University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-09-11
Study Completion Date2026-06-30

Study Record Updates

Study Start Date2025-09-11
Study Completion Date2026-06-30

Terms related to this study

Additional Relevant MeSH Terms

  • Breast Cancer