REFRESH Study
This study has two parts.
In Part 1, 15 gynecologic cancer survivors will receive three candidate intervention components known to reduce sleep disturbance (i.e., sleep restriction, stimulus control, systematic light exposure) simultaneously for six weeks. Participants will then complete semi-structured individual interviews to provide feedback about barriers to and facilitators of intervention adherence. Results of Part 1 will inform the design and delivery of the candidate components in Part 2.
In Part 2, a 2^3 full factorial design will be followed to randomize 80 gynecologic cancer survivors to one of eight six-week intervention conditions reflecting all possible combinations of the three candidate intervention components.
Basic eligibility criteria:
Please contact the study coordinator for additional eligibility information.
- History of Stage I, II, or III gynecologic cancer
- Age 18-74 years
- English language proficiency
- Current sleep disturbance
- Usual sleep onset time between 9:00PM and 3:00AM
- Reliable telephone and Internet access
Primary disease category: Gynecologic Cancers
Secondary disease categories: Sleep Disorders
Sponsor: National Cancer Institute (NCI)
Protocol number: STUDY00000253
Projected enrollment dates: February 2022 to January 2026
Official study title: Improving Sleep in Gynecologic Cancer Survivors
ClinicalTrials.gov page:
http://www.clinicaltrials.gov/show/NCT05044975