Sleep Treatment Education Program for Cancer Survivors: STEP-Together

NCT ID: NCT06736548

Last Updated: 2025-07-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-25
• Study Completion Date: 2026-12-31

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.

Detailed 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 virtual group session.

The research study procedures including screening for eligibility and questionnaires.

Participation in this research study is expected to last about 16 weeks.

It is expected about 90 people will participate in this research study.

Conditions

Insomnia; Insomnia Chronic; Survivorship

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

STEP-Together Intervention

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.

Group Type: EXPERIMENTAL

The Sleep Treatment Education Program Together (STEP-Together)

Intervention Type: 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.

Coaching Session

Intervention Type: 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.

Interventions

The Sleep Treatment Education Program Together (STEP-Together)

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.

Intervention Type: BEHAVIORAL

Coaching Session

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

STEP-Together

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Dana-Farber Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Christopher Recklitis, PhD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christopher Recklitis, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Locations

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

STEP-Together Coordinator

Role: CONTACT

STEP@dfci.harvard.edu

617-582-8269

Cheryl Medeiros-Nancarrow

Role: CONTACT

STEP@dfci.harvard.edu

617-582-8269

Facility Contacts

STEP-Together Coordinator

Role: primary

STEP@dfci.harvard.edu

617-582-8269

Cheryl Medeiros-Nancarrow

Role: backup

cheryl_nancarrow@dfci.harvard.edu

617-582-8269

Other Identifiers

24-505

Identifier Type: -

Identifier Source: org_study_id