RECRUITING

Sleep Treatment Education Program for Cancer Survivors: STEP-Together

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Conditions

InsomniaInsomnia ChronicSurvivorshipChronic InsomniaCancer Survivorship

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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 synchronous group session by videoconference.

Official Title

Sleep Treatment Education Program Together (STEP-Together): An Online Group Educational Intervention for Insomnia in Cancer Survivors

Quick Facts

Study Start:2025-04-17
Study Completion:2026-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06736548

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 89 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 18-89
  2. * History of a cancer diagnosis (except non-melanoma skin cancer) ≥ 6 months prior
  3. * No active cancer therapy (excluding chemoprevention) in the past four months, and no further therapy planned.
  4. * Significant insomnia as evidenced by an Insomnia Severity Index score ≥ 8
  5. * Regular access to the internet
  6. * Able to read and write in English
  1. * Usual bedtime does not fall between 5:00 pm and 5:00 am.
  2. * Employment in a position where falling asleep at work could impact public safety (such as air traffic-controller, operating heavy machinery).
  3. * 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.
  4. * Any impairment (e.g., hearing, visual, cognitive) that interferes with the ability to complete all study procedures independently.

Contacts and Locations

Study Contact

STEP-Together Coordinator
CONTACT
617-582-8269
STEP@dfci.harvard.edu
Cheryl Medeiros-Nancarrow
CONTACT
617-582-8269
STEP@dfci.harvard.edu

Principal Investigator

Christopher Recklitis, PhD, MPH
PRINCIPAL_INVESTIGATOR
Dana-Farber Cancer Institute

Study Locations (Sites)

Dana Farber Cancer Institute
Boston, Massachusetts, 02115
United States

Collaborators and Investigators

Sponsor: Dana-Farber Cancer Institute

  • Christopher Recklitis, PhD, MPH, PRINCIPAL_INVESTIGATOR, Dana-Farber Cancer Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-17
Study Completion Date2026-12-31

Study Record Updates

Study Start Date2025-04-17
Study Completion Date2026-12-31

Terms related to this study

Keywords Provided by Researchers

  • Insomnia
  • Chronic Insomnia
  • Cancer Survivorship

Additional Relevant MeSH Terms

  • Insomnia
  • Insomnia Chronic
  • Survivorship