Sleep Treatment Education Program for Cancer Survivors: STEP-Together (NCT06736548) | Clinical Trial Compass
By InvitationNot Applicable
Sleep Treatment Education Program for Cancer Survivors: STEP-Together
United States100 participantsStarted 2025-06-25
Plain-language 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.
Who can participate
Age range
18 Years – 89 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is specifically for cancer survivors dealing with insomnia — does my current situation and cancer history make me someone you'd consider discussing this program with?
2The study is measuring changes in insomnia severity over 8 weeks using a standard scale called the Insomnia Severity Index — how does that timeline compare to other insomnia treatments I might try, and is 8 weeks realistic for seeing a meaningful difference?
3Since this trial is listed as 'enrolling by invitation,' can you explain how patients typically get referred or connected to it, and whether that's even a path available to me through your practice or network?
4This appears to be a behavioral or educational sleep program rather than a medication-based approach — would you recommend I try something like this before or alongside any sleep medications I'm currently taking or considering?
5Are there standard insomnia treatments, like cognitive behavioral therapy for insomnia, that are already well-established for cancer survivors, and how would you compare those options to participating in a study like this one where outcomes are still being measured?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Insomnia Severity Index (ISI) Score from Baseline to 8 weeks Post-Intervention