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

NCT ID: NCT06938802

Last Updated: 2025-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-21

Study Completion Date

2025-12-16

Brief Summary

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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

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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.

Conditions

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Cancer

Keywords

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Sleep quality Psycho-oncology

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Sleep coaching

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

Group Type EXPERIMENTAL

Sleep coaching

Intervention Type BEHAVIORAL

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

Sleep education

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

Group Type ACTIVE_COMPARATOR

Sleep education

Intervention Type BEHAVIORAL

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

Interventions

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Sleep education

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

Intervention Type BEHAVIORAL

Sleep coaching

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Arizona

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rina S. Fox, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Arizona College of Nursing

Locations

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University of Arizona Cancer Center

Tucson, Arizona, United States

Site Status

Countries

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United States

Other Identifiers

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STUDY00005996

Identifier Type: -

Identifier Source: org_study_id