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

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

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 Overview

• Status: Completed
• Conditions: Cancer
• Intervention / Treatment: Behavioral: Sleep coaching; Behavioral: Sleep education

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85719
      • University of Arizona Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sleep coaching; Participants will receive an 8-week sleep coaching program delivered by smartphone/tablet app	Behavioral: Sleep coaching; Participants will receive an 8-week sleep coaching program delivered by smartphone/tablet app
Active Comparator: Sleep education; Participants will receive electronic access to educational information about sleep for 8 weeks	Behavioral: Sleep education; Participants will receive electronic access to educational information about sleep for 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in sleep health from baseline to immediately after the intervention	Participants will complete 8-item short forms of the Patient-Reported Outcomes Measurement Information System (PROMIS) sleep disturbance and sleep-related impairment measures at baseline and immediately after the intervention. Raw scores will be converted to T-scores with a mean of 50 and a standard deviation of 10. Higher scores on PROMIS measures indicate more of the underlying construct.	8 weeks - Immediately after the intervention
Change in insomnia symptoms from baseline to immediately after the intervention	Participants will complete 7-item Insomnia Severity Index at baseline and immediately after the intervention. Scores range from 0-28 with higher scores indicating more acute symptoms of insomnia.	8 weeks - Immediately after the intervention
Change in symptom burden from baseline to immediately after the intervention	Participants will complete PROMIS scales assessing fatigue, anxiety, and depression at baseline and immediately after the intervention. Raw scores will be converted to T-scores with a mean of 50 and a standard deviation of 10. Higher scores on PROMIS measures indicate more of the underlying construct.	8 weeks - Immediately after the intervention

Collaborators and Investigators

• Sponsor: University of Arizona
• Investigators: Principal Investigator: Rina S. Fox, PhD, MPH, University of Arizona College of Nursing

Study record dates

Study Major Dates

• Study Start (Actual): July 21, 2025
• Primary Completion (Actual): December 16, 2025
• Study Completion (Actual): December 16, 2025

Study Registration Dates

• First Submitted: April 14, 2025
• First Submitted That Met QC Criteria: April 14, 2025
• First Posted (Actual): April 22, 2025

Study Record Updates

• Last Update Posted (Actual): December 18, 2025
• Last Update Submitted That Met QC Criteria: December 17, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Sleep quality; Psycho-oncology
• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Neoplasms; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: STUDY00005996

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No