NCT05044975

Improving Sleep in Gynecologic Cancer Survivors

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 95 (estimated)
• Sponsor: University of Arizona · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This purpose of this study is to learn about how to provide treatment to gynecologic cancer survivors who have difficulty sleeping.

Detailed description

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.

Conditions

• Sleep Disturbance
• Gynecologic Cancer

Interventions

Type	Name	Description
BEHAVIORAL	Sleep restriction	Participants will receive sleep restriction intervention
BEHAVIORAL	Stimulus control	Participants will receive stimulus control intervention
BEHAVIORAL	Systematic light exposure	Participants will receive systematic light exposure intervention

Timeline

• Start date: 2021-10-11
• Primary completion: 2026-01-31
• Completion: 2026-01-31
• First posted: 2021-09-16
• Last updated: 2025-05-01

Locations

2 sites across 1 country: United States