RECRUITING

Pilot Study of App-delivered Sleep Coaching Among Cancer Survivors and Their Partners

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Conditions

CancerSleep qualityPsycho-oncology

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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

The proposed study will test the feasibility and acceptability of enrolling and retaining cancer survivors and their bedroom partners in a study evaluating digitally delivered behavioral sleep interventions.

Official Title

Pilot Study of App-delivered Sleep Coaching Among Cancer Survivors and Bedroom Partners

Quick Facts

Study Start:2025-07-01
Study Completion:2025-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06938802

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:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Diagnosed with any cancer,
  2. 2. Completed curative treatment six months to five years before enrolling (excepting ongoing adjuvant endocrine therapy),
  3. 3. Score 8 to 14 on the Insomnia Severity Index (ISI)
  4. 4. Have a consistent bedroom partner (i.e., sleep in the same bedroom 4 or more nights per week).
  5. 1. Age \> or =18 years,
  6. 2. Able to speak and read English,
  7. 3. Able to provide informed consent,
  8. 4. No changes in type or dose of prescription sleep medications in the past three months,
  9. 5. Not engaged in behavioral sleep treatment for six months prior to enrollment,
  10. 6. Not planning to travel across 3 time zones or more during the eight intervention weeks or for the two weeks leading up to study assessments,
  11. 7. Not pregnant at enrollment or planning to become pregnant during the study,
  12. 8. No diagnosed or suspected psychiatric or medical condition that could interfere with participation,
  13. 9. No commitments that would interfere with regular night time sleep patterns (e.g., shift work),
  14. 10. No known untreated non-insomnia sleep disorders (e.g., sleep apnea, restless legs syndrome, hypersomnia, circadian rhythm sleep-wake disorder).
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Rina S. Fox, PhD, MPH
CONTACT
520-626-3071
rsfox@arizona.edu
Marjorie A Nelson
CONTACT
520-626-6154
marjoriebarrera1@arizona.edu

Principal Investigator

Rina S. Fox, PhD, MPH
PRINCIPAL_INVESTIGATOR
University of Arizona College of Nursing

Study Locations (Sites)

University of Arizona Cancer Center
Tucson, Arizona, 85719
United States

Collaborators and Investigators

Sponsor: University of Arizona

  • Rina S. Fox, PhD, MPH, PRINCIPAL_INVESTIGATOR, University of Arizona College of Nursing

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 Date2025-07-01
Study Completion Date2025-12-31

Study Record Updates

Study Start Date2025-07-01
Study Completion Date2025-12-31

Terms related to this study

Keywords Provided by Researchers

  • Sleep quality
  • Psycho-oncology

Additional Relevant MeSH Terms

  • Cancer