Sleep Treatment Education Program for Cancer Survivors: STEP-Together
Part of paid clinical trials in Boston, Massachusetts.
- Sponsor
- Dana-Farber Cancer Institute
- Study ID
- NCT06736548
- Status
- Recruiting
Conditions
- Insomnia
- Insomnia Chronic
- Survivorship
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 89 Years
- Healthy Volunteers
- Accepted
Interventions
- The Sleep Treatment Education Program Together (STEP-Together) — BEHAVIORALSTEP-Together is delivered in a single videoconference group session delivered live by a presenter. During the session, the participants are able to see and hear the presenter, view the presentation slides, and ask questions. The presentation includes educational information on the problem of insomnia after cancer and specific suggestions for improving sleep. Suggestions are presented in four sections addressing lifestyle issues, sleep environment, sleep timing, and managing expectations and challenges. During the course of the session, participants are asked to use these suggestions to develop an individual sleep action plan they will use to improve their sleep.
- Coaching Session — BEHAVIORALCoaching sessions are brief (\<1hour) sessions intended to support participants in implementing their personal sleep self-management plan. In the session, participants are asked to review their progress with their plan, report on areas of sucess and difficulty with adoption, and to problem solve with the study team as needed to support their sucessful implementation their plan.
Study Details
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.
Key Dates
- Start date
- Jun 25, 2025
- Status verified
- Jul 2025
- Primary completion
- Oct 31, 2026
- Completion
- Dec 31, 2026
Study Design
- Enrollment
- 100 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: STEP-Together InterventionEnrolled participants will complete the educational intervention session (STEP-Together) delivered by an interventionist during an online group videoconference session. -Up to 12 participants will also take part in a coaching session 1 week after the virtual intervention session.
Primary Outcome Measure
Change in Insomnia Severity Index (ISI) Score from Baseline to 8 weeks Post-Intervention [ Time Frame: Baseline to 8 weeks post-intervention ]
Central Contacts
- STEP-Together Coordinator617-582-8269
- Cheryl Medeiros-Nancarrow617-582-8269
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Dana Farber Cancer Institute | Boston | Massachusetts | 02115 | Christopher Recklitis, PhD, MPH (PRINCIPAL_INVESTIGATOR) |
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