CancerACCESSNCT06938802
Pilot Study of App-delivered Sleep Coaching Among Cancer Survivors and Their Partners
A study testing Sleep coaching and Sleep education in people with Cancer, run by University of Arizona at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cancer
- What is being tested?
- Sleep coaching and Sleep education
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jul 2025to 16 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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:
- 1) No cancer within the past five years
Show all 10Show fewer
- Both survivors and bedroom partners:
- Age > or =18 years,
- Able to speak and read English,
- Able to provide informed consent,
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arizona Cancer Center
Tucson, Arizona, 85719
About this study
Official title: 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.
Read the 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.
- Conditions
- Cancer
- Being tested
- Sleep coaching, Sleep education
- Keywords
- Sleep quality, Psycho-oncology
- Medical subject headings
- Neoplasms, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep coachingBehavioural
Participants will receive an 8-week sleep coaching program delivered by smartphone/tablet app
Sleep educationBehavioural
Participants will receive electronic access to educational information about sleep for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Sleep coaching | Experimental | Participants will receive an 8-week sleep coaching program delivered by smartphone/tablet app Receives: Behavioral: Sleep coaching |
| Sleep education | Active comparator | Participants will receive electronic access to educational information about sleep for 8 weeks Receives: Behavioral: Sleep education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: Throughout the recruitment period
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: 8 weeks - Immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2025
- Study start21 Jul 2025
- Primary completion16 Dec 2025
- Study completion16 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rina S. Fox, PhD, MPH, Principal investigator, University of Arizona College of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06938802
- Sponsor's protocol ID
- STUDY00005996
- Acronym
- ACCESS
- Status last verified
- Dec 2025
- First submitted
- 14 Apr 2025
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of App-delivered Sleep Coaching Among Cancer Survivors and Bedroom Partners
- ClinicalTrials.gov ID
- NCT06938802
- Acronym / sponsor ID
- ACCESS / STUDY00005996
- Conditions
- Cancer
- Keywords
- Sleep quality, Psycho-oncology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Study start
- 21 Jul 2025 (actual)
- Primary completion
- 16 Dec 2025 (actual)
- Study completion
- 16 Dec 2025 (actual)
- First posted
- 22 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sleep coaching | Experimental | Behavioral: Sleep coachingParticipants will receive an 8-week sleep coaching program delivered by smartphone/tablet app |
| Sleep education | Active comparator | Behavioral: Sleep educationParticipants will receive electronic access to educational information about sleep for 8 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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).
- 1) No cancer within the past five years
Key exclusion criteria (8 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sleep coachingParticipants will receive an 8-week sleep coaching program delivered by smartphone/tablet app | Behavioural | Sleep coaching |
| Sleep educationParticipants will receive electronic access to educational information about sleep for 8 weeks | Behavioural | Sleep education |
Primary outcome
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.
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
3 secondary outcomes
Change in sleep health from baseline to immediately after the intervention
Time frame: 8 weeks - Immediately after the intervention
Change in insomnia symptoms from baseline to immediately after the intervention
Time frame: 8 weeks - Immediately after the intervention
Change in symptom burden from baseline to immediately after the intervention
Time frame: 8 weeks - Immediately after the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rina S. Fox, PhD, MPH principal investigator
University of Arizona College of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep coaching and Sleep education in people with Cancer, run by University of Arizona at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Satisfaction assessed by study-specific survey after the intervention - acceptability (time frame: 8 weeks - Immediately after the intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2025.