Skip to main content
OpenTrials
Completed

NCT Number: NCT06938802

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Arizona Cancer Center

Tucson, Arizona, 85719, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Cancer Survivor eligibility criteria:

Inclusion criteria

  • 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:

Inclusion:

  • Age > or =18 years,
  • Able to speak and read English,
  • Able to provide informed consent,

Exclusion:

  • 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.

Treatment and study plan

Sleep coaching

Behavioral

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

Sleep Education

Behavioral

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

Primary outcomes

  1. Satisfaction assessed by study-specific survey after the intervention - acceptability

    Time frame: 8 weeks - Immediately after the intervention

    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.

  2. Feasibility assessed by recruitment and retention rates

    Time frame: Throughout the recruitment period

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

Secondary outcomes

  1. Change in sleep health from baseline to immediately after the intervention

    Time frame: 8 weeks - 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.

  2. Change in insomnia symptoms from baseline to immediately after the intervention

    Time frame: 8 weeks - 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.

  3. Change in symptom burden from baseline to immediately after the intervention

    Time frame: 8 weeks - 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.

Sponsors and collaborators

Lead sponsor

University of Arizona

Other

Registry information

Official study title

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

Acronym: ACCESS

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 22, 2025
Registry last updated
Dec 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.