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

University of Arizona

Status: Not yet enrolling

Conditions: Cancer

Treatments: Behavioral: Sleep coaching; Behavioral: Sleep education

Study type: Interventional

Funder types: Other

Identifiers

NCT06938802

STUDY00005996

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Sleep coaching

Experimental group

Description:

Participants will receive an 8-week sleep coaching program delivered by smartphone/tablet app

Treatment:

Behavioral: Sleep coaching

Sleep education

Active Comparator group

Description:

Participants will receive electronic access to educational information about sleep for 8 weeks

Treatment:

Behavioral: Sleep education