A program to help cancer survivors with insomnia
Sleep Treatment Education Program Together (STEP-Together): An Online Group Educational Intervention for Insomnia in Cancer Survivors
This study is testing a virtual group program to see if it can help cancer survivors who have trouble sleeping feel better over 16 weeks.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 89 Years |
| Sex | All |
| Sponsor | Dana-Farber Cancer Institute Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT06736548 on ClinicalTrials.gov |
What this trial studies
This research focuses on off-treatment cancer survivors who experience insomnia. Participants will engage in the Sleep Treatment Education Program Together (STEP-Together), which is delivered through virtual group sessions. The study aims to assess the effectiveness of this program over a 16-week period, with approximately 90 participants expected to take part. Eligibility screening and questionnaires will be utilized to ensure participants meet the criteria for significant insomnia.
Who should consider this trial
Good fit: Ideal candidates are cancer survivors aged 18-89 who have experienced insomnia for at least six months and have no active cancer treatment planned.
Not a fit: Patients currently undergoing cancer treatment or those with certain psychiatric or neurological disorders may not benefit from this program.
Why it matters
Potential benefit: If successful, this program could significantly improve sleep quality and overall well-being for cancer survivors suffering from insomnia.
How similar studies have performed: Other studies have shown positive outcomes with similar educational interventions for insomnia, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Boston, Massachusetts
- Dana Farber Cancer Institute — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Christopher Recklitis, PhD, MPH — Dana-Farber Cancer Institute
- Study coordinator: STEP-Together Coordinator
- Email: STEP@dfci.harvard.edu
- Phone: 617-582-8269
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.