Sleep Treatment Education Program-1 (STEP-1)

Completed · Not applicable

Conditions studied: Cancer Survivors, Insomnia

In brief

The purpose of the study is to learn if single session online education programs can help improve cancer survivors' sleep.

Key facts

Study ID

NCT05519982

Run by

Dana-Farber Cancer Institute

People needed

70

Starts

2023-03-10

Expected to finish

2024-10-11

Last updated by the study team

2026-02-02

Who can join

Age: 40 and older, up to 89. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 40-89
• History of a cancer diagnosis (except non-melanoma skin cancer) ≥ 1 year prior
• No active cancer therapy (excluding chemoprevention) in the past four months, and no further therapy planned
• Significant insomnia as evidenced by an Insomnia Severity Index score ≥12
• Regular access to the internet on a daily basis
• Able to read and write in English

You may not qualify if…

• Survivors who report ever being diagnosed with Bipolar Disorder.
• Survivors who report ever being diagnosed with a Seizure Disorder or have experienced a seizure in the past 12 months.
• Intention to adjust (decrease or increase) use of any prescribed or over-the-counter medications taken to decrease insomnia during the study period.
• Survivors diagnosed with sleep apnea who have declined treatment or are not adherent with treatment (as assessed by screening questions, see Appendix A).
• Survivors with suspected sleep apnea who have not completed an evaluation by a sleep specialist (as assessed by screening questions, see Appendix A).
• Usual bedtime does not fall between 5:00 pm and 5:00 am.
• Employment that involves irregular sleep patterns, such as shift-work or frequent long-distance travel across time zones, or employment in a position that could impact public safety (such as air traffic-controller, operating heavy machinery)
• Any impairment (e.g., hearing, visual, cognitive) that interferes with the ability to complete all study procedures independently.
• Prior participation in a research study which provided an educational or behavioral intervention for insomnia.
• Prior participation in a behavioral treatment or patient education program for insomnia delivered at the Dana-Farber Cancer Institute, or at Boston Children's Hospital.
• Participation in behavioral or educational interventions for insomnia in the 2 years prior to enrollment. This includes in-person as well as synchronous and asynchronous online insomnia programs, but not independent use of books, workbooks or other written self-help materials addressing insomnia.

Where it is running

• Dana Farber Cancer Institute — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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