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NCT06736548 | NOT YET RECRUITING | Insomnia

Sleep Treatment Education Program for Cancer Survivors: STEP-Together
Sponsor:

Dana-Farber Cancer Institute

Information provided by (Responsible Party):

Christopher Recklitis, PhD

Brief Summary:

This single-arm research study of off-treatment cancer survivors with self-reported symptoms of insomnia will test the Sleep Treatment Education Program Together (STEP-Together) intervention which is delivered as a synchronous group session by videoconference.

Condition or disease

Insomnia

Insomnia Chronic

Survivorship

Intervention/treatment

The Sleep Treatment Education Program Together (STEP-Together)

Coaching Session

Phase

NA

Detailed Description:

This single-arm research study of off-treatment cancer survivors with self-reported symptoms of insomnia will test the Sleep Treatment Education Program Together (STEP-Together) intervention which is delivered as a virtual group session. The research study procedures including screening for eligibility and questionnaires. Participation in this research study is expected to last about 16 weeks. It is expected about 90 people will participate in this research study.

Study Type : INTERVENTIONAL
Estimated Enrollment : 100 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Sleep Treatment Education Program Together (STEP-Together): An Online Group Educational Intervention for Insomnia in Cancer Survivors
Actual Study Start Date : 2025-05
Estimated Primary Completion Date : 2026-10-31
Estimated Study Completion Date : 2026-12-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 89 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
Criteria
Inclusion Criteria
  • * Age 18-89
  • * History of a cancer diagnosis (except non-melanoma skin cancer) ≥ 6 months 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 ≥ 8
  • * Regular access to the internet
  • * Able to read and write in English
Exclusion Criteria
  • * Usual bedtime does not fall between 5:00 pm and 5:00 am.
  • * Employment in a position where falling asleep at work could impact public safety (such as air traffic-controller, operating heavy machinery).
  • * Ever diagnosed with Bipolar Disorder or with Seizure Disorder, currently taking medications to prevent a seizure, or have experienced a seizure in the prior 12 months.
  • * Any impairment (e.g., hearing, visual, cognitive) that interferes with the ability to complete all study procedures independently.
Sleep Treatment Education Program for Cancer Survivors: STEP-Together

Location Details

NCT06736548

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

United States, Massachusetts

Dana Farber Cancer Institute

Boston, Massachusetts, United States, 02115