Status:
COMPLETED
Pilot Study of App-delivered Sleep Coaching Among Cancer Survivors and Their Partners
Lead Sponsor:
University of Arizona
Conditions:
Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 interve...
Detailed Description
Poor sleep is a common issue among cancer survivors that can persist for years and has been linked to increased symptoms (e.g., depression, fatigue), worse quality of life, and worse clinical outcomes...
Eligibility Criteria
Inclusion
- Cancer Survivor eligibility criteria:
- Inclusion Criteria:
- Diagnosed with any cancer,
- Completed curative treatment six months to five years before enrolling (excepting ongoing adjuvant endocrine therapy),
- Score 8 to 14 on the Insomnia Severity Index (ISI)
- Have a consistent bedroom partner (i.e., sleep in the same bedroom 4 or more nights per week).
- Bedroom partner eligibility criteria:
- 1\) No cancer within the past five years
- Both survivors and bedroom partners:
- Inclusion:
- Age \> or =18 years,
- Able to speak and read English,
- Able to provide informed consent,
- Exclusion:
- No changes in type or dose of prescription sleep medications in the past three months,
- Not engaged in behavioral sleep treatment for six months prior to enrollment,
- 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,
- Not pregnant at enrollment or planning to become pregnant during the study,
- No diagnosed or suspected psychiatric or medical condition that could interfere with participation,
- No commitments that would interfere with regular night time sleep patterns (e.g., shift work),
- No known untreated non-insomnia sleep disorders (e.g., sleep apnea, restless legs syndrome, hypersomnia, circadian rhythm sleep-wake disorder).
- Enrolled participants will be allowed to remain in the study even if the other member of their dyad withdraws.
Exclusion
Key Trial Info
Start Date :
July 21 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 16 2025
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06938802
Start Date
July 21 2025
End Date
December 16 2025
Last Update
December 18 2025
Active Locations (1)
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1
University of Arizona Cancer Center
Tucson, Arizona, United States, 85719