Pilot Study of App-delivered Sleep Coaching Among Cancer Survivors and Bedroom Partners
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Arizona
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Satisfaction assessed by study-specific survey after the intervention - acceptability
Study Overview
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 interventions.
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 like cancer progression and mortality. Partners of cancer survivors also experience poor sleep, but current interventions typically focus on survivors, leaving partners underrepresented. 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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:
- •Age > or =18 years,
- •Able to speak and read English,
- •Able to provide informed consent,
Exclusion Criteria
- •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.
Arms & Interventions
Sleep coaching
Participants will receive an 8-week sleep coaching program delivered by smartphone/tablet app
Intervention: Sleep coaching (Behavioral)
Sleep education
Participants will receive electronic access to educational information about sleep for 8 weeks
Intervention: Sleep education (Behavioral)
Outcomes
Primary Outcomes
Satisfaction assessed by study-specific survey after the intervention - acceptability
Time Frame: 8 weeks - Immediately after the intervention
The intervention/study will be deemed acceptable if, on average, participants report satisfaction with the overall program/study as ≥2 on a 0-4 scale.
Feasibility assessed by recruitment and retention rates
Time Frame: Throughout the recruitment period
The intervention/study will be deemed feasible if 50% of eligible potential participants enroll and 75% of enrolled participants are retained at post-intervention
Secondary Outcomes
- Change in sleep health from baseline to immediately after the intervention(8 weeks - Immediately after the intervention)
- Change in insomnia symptoms from baseline to immediately after the intervention(8 weeks - Immediately after the intervention)
- Change in symptom burden from baseline to immediately after the intervention(8 weeks - Immediately after the intervention)