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Search / Trial NCT06736548

Sleep Treatment Education Program for Cancer Survivors: STEP-Together

Launched by DANA-FARBER CANCER INSTITUTE · Dec 12, 2024

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Insomnia Chronic Insomnia Cancer Survivorship

ClinConnect Summary

The STEP-Together trial is studying a program designed to help cancer survivors who are experiencing trouble sleeping, known as insomnia. This program, called the Sleep Treatment Education Program Together, will be conducted through group video sessions, making it accessible for participants to join from home. The goal is to see if this program can improve sleep for people who have finished cancer treatment and are reporting significant insomnia symptoms.

To be eligible for the study, participants need to be between 18 and 89 years old and must have been diagnosed with cancer (except for certain skin cancers) at least six months ago. They should not have received any cancer treatment in the last four months and must have access to the internet. Participants also need to be able to read and write in English. However, those with certain conditions, such as severe sleep issues outside the study's guidelines or specific mental health diagnoses, won't be able to take part. If you qualify and join, you can expect to participate in online group sessions focused on improving your sleep with guidance from trained professionals.

Gender

ALL

Eligibility 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.

About Dana Farber Cancer Institute

The Dana-Farber Cancer Institute is a premier cancer research and treatment institution located in Boston, Massachusetts. Renowned for its commitment to advancing cancer care through innovative research, the institute integrates cutting-edge clinical trials with a multidisciplinary approach to patient care. With a focus on translating scientific discoveries into effective therapies, Dana-Farber collaborates with a network of leading researchers and healthcare professionals to improve outcomes for patients with cancer. The institute’s dedication to education, advocacy, and community engagement further underscores its mission to eradicate cancer and enhance the quality of life for those affected by the disease.

Locations

Boston, Massachusetts, United States

Patients applied

0 patients applied

Trial Officials

Christopher Recklitis, PhD, MPH

Principal Investigator

Dana-Farber Cancer Institute

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported