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

NCT06938802 | Completed

• 1 other identifier: STUDY00005996
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Keywords

Sleep quality; Psycho-oncology

Outcome Measures

Primary Outcomes (2)

• Satisfaction assessed by study-specific survey after the intervention - acceptability

  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.

  8 weeks - Immediately after the intervention

• Feasibility assessed by recruitment and retention rates

  The intervention/study will be deemed feasible if 50% of eligible potential participants enroll and 75% of enrolled participants are retained at post-intervention

  Throughout the recruitment period

Secondary Outcomes (3)

• 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

Study Arms (2)

Sleep coaching

EXPERIMENTAL

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

Behavioral: Sleep coaching

Sleep education

ACTIVE COMPARATOR

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

Behavioral: Sleep education

Interventions

Sleep coaching BEHAVIORAL

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

Sleep coaching

Sleep education BEHAVIORAL

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

Sleep education

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• \) 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,

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Arizona: lead

Study Sites (1)

University of Arizona Cancer Center

Tucson, Arizona, 85719, United States

Location

MeSH Terms

Conditions

Neoplasms; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Rina S. Fox, PhD, MPH

  University of Arizona College of Nursing

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2025
• First Posted: April 22, 2025
• Study Start: July 21, 2025
• Primary Completion: December 16, 2025
• Study Completion: December 16, 2025
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)