University of Arizona Cancer Center
Tucson, Arizona, 85719, United States
NCT Number: NCT06938802
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Tucson, Arizona, 85719, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Cancer Survivor eligibility criteria:
Inclusion criteria
Bedroom partner eligibility criteria:
Both survivors and bedroom partners:
Inclusion:
Exclusion:
Enrolled participants will be allowed to remain in the study even if the other member of their dyad withdraws.
Participants will receive an 8-week sleep coaching program delivered by smartphone/tablet app
Participants will receive electronic access to educational information about sleep for 8 weeks
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.
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
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.
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.
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.
University of Arizona
Other
Pilot Study of App-delivered Sleep Coaching Among Cancer Survivors and Bedroom Partners
Acronym: ACCESS
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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.
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