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CompletedNo phase

Sleep Treatment Education Program-1 (STEP-1)

Key facts

Who runs it
Dana-Farber Cancer Institute
Where
Boston, United StatesSee the site
Trial code
Status
Completed
People taking part
70 people enrolled
Started
10 Mar 2023
Ended
11 Oct 2024
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Sleep Treatment Education Program (STEP-1)
  • Enhanced Usual Care
Record updated
2 February 2026

Who can take part

Age
40 years to 89 years
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 17 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Intention to adjust (decrease or increase) use of any prescribed or over-the-counter medications taken to decrease insomnia during the study period
  • 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
  • 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
  • Any impairment (e.g., hearing, visual, cognitive) that interferes with the ability to complete all study procedures independently
  • 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)

Where in United States

  • Dana-Farber Cancer InstituteBoston, United States

About the trial

What the trial wants to find out

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

The 2 groups in the trial

  • Sleep Treatment Education Program (STEP-1)Treatment being tested

    Prior to being randomized, all participants will complete health questionnaires. Participants assigned to the Sleep Treatment Education Program (STEP-1) group will receive online instruction on making changes to sleep habits and health behaviors. Participants will be contacted at 1 month and 2 months after the education session to complete follow up online questionnaires.

  • Enhanced Usual Care: Relaxation EducationExisting treatment, for comparison

    Prior to being randomized, all participants will complete health questionnaires. Participants assigned to the Enhanced Usual Care group will receive information on relaxation techniques to improve sleep Participants will be contacted at 1 month and 2 months after the education session to complete follow up online questionnaires.

    Treatment: Enhanced Usual Care

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Sleep Treatment Education Program (STEP-1): An Online Educational Intervention for Insomnia in Cancer Survivors
Record updated
2 February 2026