Clinical trial NCT06938802: Pilot Study of App-delivered Sleep Coaching Among Cancer Survivors and Their Partners
Official title: Pilot Study of App-delivered Sleep Coaching Among Cancer Survivors and Bedroom Partners
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cancer
Keywords: Sleep quality
Psycho-oncology
Lead sponsor: University of Arizona
Sponsor class: OTHER
First posted: 2025-04-22
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Cancer Survivor eligibility criteria:

Inclusion Criteria:

1. Diagnosed with any cancer,
2. Completed curative treatment six months to five years before enrolling (excepting ongoing adjuvant endocrine therapy),
3. Score 8 to 14 on the Insomnia Severity Index (ISI)
4. 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:

1. Age \> or =18 years,
2. Able to speak and read English,
3. Able to provide informed consent,

   Exclusion:
4. No changes in type or dose of prescription sleep medications in the past three months,
5. Not engaged in behavioral sleep treatment for six months prior to enrollment,
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,
7. Not pregnant at enrollment or planning to become pregnant during the study,
8. No diagnosed or suspected psychiatric or medical condition that could interfere with participation,
9. No commitments that would interfere with regular night time sleep patterns (e.g., shift work),
10. 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.

Primary outcomes:
measure: Satisfaction assessed by study-specific survey after the intervention - acceptability
timeFrame: 8 weeks - Immediately after the intervention
measure: Feasibility assessed by recruitment and retention rates
timeFrame: Throughout the recruitment period
Secondary outcomes:
measure: Change in sleep health from baseline to immediately after the intervention
timeFrame: 8 weeks - Immediately after the intervention
measure: Change in insomnia symptoms from baseline to immediately after the intervention
timeFrame: 8 weeks - Immediately after the intervention
measure: Change in symptom burden from baseline to immediately after the intervention
timeFrame: 8 weeks - Immediately after the intervention
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona Cancer Center
state: Arizona
Study officials:
affiliation: University of Arizona College of Nursing
name: Rina S. Fox, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: