Sleep Treatment Education Program for Cancer Survivors: STEP-Together

NCT06736548 | Recruiting

• 1 other identifier: 24-505
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Insomnia; Insomnia Chronic; Survivorship

Keywords

Insomnia; Chronic Insomnia; Cancer Survivorship

Outcome Measures

Primary Outcomes (1)

• Change in Insomnia Severity Index (ISI) Score from Baseline to 8 weeks Post-Intervention

  Assessed by the Insomnia Severity Index, a 7-item measure measuring insomnia over the previous two weeks with answers graded on a 5-point Likert scale, ranging from 0 "No Problem" to "4 "Very Severe" for a total score range of 0 to 28. A higher score reflects moderate to severe insomnia symptoms.

  Baseline to 8 weeks post-intervention

Secondary Outcomes (3)

• Change in Total Mood Disturbance (TMD) Scale from the Profile of Mood States - Short Form (POMS-SF) Score from Baseline to 8 weeks Post-Intervention

  Baseline to 8 weeks post-intervention

• Change in Perceived Cognitive impairment Scale from Baseline to 8 weeks Post-Intervention

  Baseline to 8 weeks post-intervention

• Change in Impact of Cognitive Function on Quality of Life Scale from Baseline to 8 weeks Post-Intervention

  Baseline to 8 weeks post-intervention

Study Arms (1)

STEP-Together Intervention

EXPERIMENTAL

Enrolled 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.

Behavioral: The Sleep Treatment Education Program Together (STEP-Together); Behavioral: Coaching Session

Interventions

The Sleep Treatment Education Program Together (STEP-Together) BEHAVIORAL

STEP-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.

Also known as: STEP-Together

STEP-Together Intervention

Coaching Session BEHAVIORAL

Coaching 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.

STEP-Together Intervention

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead

Study Sites (1)

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

RECRUITING

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Christopher Recklitis, PhD, MPH

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

STEP-Together Coordinator

CONTACT

617-582-8269; STEP@dfci.harvard.edu

Cheryl Medeiros-Nancarrow

CONTACT

617-582-8269; STEP@dfci.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Single Group

Study Record Dates

• First Submitted: December 12, 2024
• First Posted: December 16, 2024
• Study Start: June 25, 2025
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 2, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu

Locations

US (1)