Sleep Treatment Education Program for Young Adult Cancer Survivors (STEP-YA)

Sleep Treatment Education Program for Young Adult Cancer Survivors (STEP-YA): An Online Educational Intervention for Insomnia

The purpose of the study is to learn if a single online education session, with or without individualized coaching sessions, can help improve young adult cancer survivors' (YACS) sleep.

The name of the study intervention is Sleep Treatment Education Program for Young Adult Cancer Survivors (STEP-YA).

Study Overview

• Status: Completed
• Conditions: Cancer; Insomnia; Insomnia Due to Medical Condition
• Intervention / Treatment: Behavioral: STEP-YA without Coaching; Behavioral: STEP-YA with Coaching

Detailed Description

This study is a randomized controlled trial of young adult cancer survivors with clinically significant symptoms of insomnia to evaluate the cognitive-behavioral based Sleep Treatment Education Program for Young Adult Cancer Survivors (STEP-YA).

All participants will take part in a single STEP-YA session, during which they will complete baseline measures prior to randomization and then receive the STEP-YA intervention. Participants will then be randomly assigned to receive the STEP-YA intervention either, 1) alone (non-coaching condition), or 2) with the addition of 2 remote coaching sessions (coaching condition). Participants will also complete follow-up measures 4 and 8 weeks post-baseline.

It expected that about 74 people will take part in this study

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Dana-Farber Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 39 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

To be determined by patient self-report from eligibility screening with potential participants. (See Appendix A for eligibility screening materials). Participants must be screened for eligibility ≤2 weeks prior to study enrollment. Participants who are screened earlier must be rescreened within this period.

• Age 20-39
• History of a cancer diagnosis (except non-melanoma skin cancer) ≥ 1 year 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 ≥12
• Able to read and write in English

Exclusion Criteria:

• Survivors who report ever being diagnosed with Bipolar Disorder.
• Survivors who report ever being diagnosed with a Seizure Disorder or have experienced a seizure in the past 12 months.
• Intention to adjust (decrease or increase) use of any prescribed or over-the-counter medications taken to decrease insomnia during the study period.
• Survivors who report being diagnosed with sleep apnea who are not receiving recommended medical treatment for their sleep apnea (as assessed by screening questions, see Appendix A).
• Survivors who report suspected sleep apnea who have not completed an evaluation by a sleep specialist (as assessed by screening questions, see Appendix A).
• Survivors who report their usual bedtime does not fall between 5:00 pm and 5:00 am.
• Employment that involves irregular sleep patterns, such as shift-work or frequent long-distance travel across time zones, or employment in a position that could impact public safety (such as air traffic-controller, operating heavy machinery)
• Any impairment (e.g., hearing, visual, cognitive) that interferes with the ability to complete all study procedures independently.
• Prior participation in a research study which provided an educational or behavioral intervention for insomnia
• Prior participation in a behavioral treatment or patient education program for insomnia delivered at the Dana-Farber Cancer Institute, or at Boston Children's Hospital.
• Participation in behavioral or educational interventions for insomnia in the 2 years prior to enrollment. This includes in-person as well as synchronous and asynchronous online insomnia programs, but not independent use of books, workbooks or other written self-help materials addressing insomnia.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: NON-COACHING CONDITION STEP-YA; Participants will receive a single online education session and complete online questionnaires then be randomized to not receive additional coaching support sessions. Participates will also complete follow up questionaires at 4 and 8 weeks post baseline.	Behavioral: STEP-YA without Coaching; Online instruction on behavioral changes to improve sleep without additional individually coached session
Experimental: COACHING CONDITION STEP-YA; Participants will receive a single online education session and complete online questionnaire then be randomized to receive 2 individualized remote coaching sessions. Participates will also complete follow up questionaires at 4 and 8 weeks post baseline.	Behavioral: STEP-YA with Coaching; Online instruction on behavioral changes to improve sleep with 2 additional individually coached session

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Insomnia Severity Change at 8 Weeks	The Insomnia Severity Index (ISI) is a 7-item measure used to evaluate insomnia severity (e.g. dissatisfaction with sleep and worry about sleep problems). Item response values are totaled to calculate a total ISI score ranging from 0-28, with higher scores indicating more insomnia symptom burden.	Baseline to 8-weeks post-intervention session

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Profile of Mood States Change at 8 Weeks	The Profile of Mood States-Short Form (POMS-SF) is a 35-item measure of mood. Items responses are totaled to calculate scores on 7 subscales: Anger-Hostility, Confusion-Bewilderment, Depression-Dejection, Fatigue-Inertia, Tension-Anxiety, Vigor-Activity, and Friendliness. The Total Mood Disturbance (TMD) score used in the study is calculated by adding together the scores of 5 subscales, Anger-Hostility, Confusion-Bewilderment, Depression-Dejection, Fatigue-Inertia, Tension-Anxiety, then subtracting the score from the Vigor-Activity subscale. TMD scores range from -20 to 100 with higher scores indicating greater impairment.	Baseline to 8-weeks post-intervention session
Profile of Mood States Change at 4 Weeks	The Profile of Mood States-Short Form (POMS-SF) is a 35-item measure of mood. Items responses are totaled to calculate scores on 7 subscales: Anger-Hostility, Confusion-Bewilderment, Depression-Dejection, Fatigue-Inertia, Tension-Anxiety, Vigor-Activity, and Friendliness. The Total Mood Disturbance (TMD) score used in the study is calculated by adding together the scores of 5 subscales, Anger-Hostility, Confusion-Bewilderment, Depression-Dejection, Fatigue-Inertia, Tension-Anxiety, then subtracting the score from the Vigor-Activity subscale. TMD scores range from -20 to 100 with higher scores indicating greater impairment.	Baseline to 4-weeks post-intervention session
Insomnia Severity Change at 4 Weeks	The Insomnia Severity Index (ISI) is a 7-item measure used to evaluate insomnia severity (e.g. dissatisfaction with sleep and worry about sleep problems). Item response values are totaled to calculate a total ISI score ranging from 0-28, with higher scores indicating more insomnia symptom burden.	Baseline to 4-weeks post-intervention session

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Insomnia Severity at 16 Weeks (Optional)	The Insomnia Severity Index (ISI) is a 7-item measure used to evaluate insomnia severity (e.g. dissatisfaction with sleep and worry about sleep problems). Item response values are totaled to calculate a total ISI score ranging from 0-28, with higher scores indicating more insomnia symptom burden.	16 weeks post-intervention session
Initial Satisfaction With Intervention Session	Study specific questionnaire assessing intervention acceptability, credibility and participant satisfaction	Up to 4 weeks post-intervention
Satisfaction With Coaching Sessions	Study specific questionnaire describing satisfaction with coaching sessions	Up to 4 weeks post-intervention
Final Satisfaction With the Intervention	Study specific questionnaire asking about participant satisfaction with the intervention	8 Weeks post-intervention session

Collaborators and Investigators

• Sponsor: Dana-Farber Cancer Institute
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Christopher J Recklitis, PhD, MPH, Dana-Farber Cancer Institute

Publications and helpful links

General Publications

• Michaud AL, Bice B, Miklos E, McCormick K, Medeiros-Nancarrow C, Zhou ES, Recklitis CJ. Sleep Treatment Education Program for Young Adult Cancer Survivors (STEP-YA): Protocol for an Efficacy Trial. JMIR Res Protoc. 2023 Nov 29;12:e52315. doi: 10.2196/52315.

Study record dates

Study Major Dates

• Study Start (Actual): November 19, 2022
• Primary Completion (Actual): July 28, 2025
• Study Completion (Actual): July 28, 2025

Study Registration Dates

• First Submitted: April 28, 2022
• First Submitted That Met QC Criteria: April 28, 2022
• First Posted (Actual): May 3, 2022

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 9, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Cancer; Insomnia; Insomnia Due to Medical Condition
• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Neoplasms; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: 21-613; R21CA261863 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
• IPD Sharing Time Frame: Data can be shared no earlier than 1 year following the date of publication
• IPD Sharing Access Criteria: Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No