Sleep Treatment Education Program-1 (STEP-1)

Sleep Treatment Education Program (STEP-1): An Online Educational Intervention for Insomnia in Cancer Survivors

The purpose of the study is to learn if single session online education programs can help improve cancer survivors' sleep.

Study Overview

• Status: Completed
• Conditions: Insomnia; Cancer Survivors
• Intervention / Treatment: Behavioral: Sleep Treatment Education Program (STEP-1); Behavioral: Enhanced Usual Care

Detailed Description

This study is a randomized controlled trial of cancer survivors with clinically significant symptoms of insomnia to evaluate the efficacy of the cognitive-behavioral intervention Sleep Treatment Education Program-1 (STEP-1).

Participants in this study will be randomized to either the behavioral education session, Sleep Treatment Education Program-1 (STEP-1), which will instruct them on how to make changes to their sleep habits and behaviors or an enhanced usual care control program which will provides them with access to online relaxation programs and instruct them about how these programs can help improve sleep.

Participation in the study involves:

• Taking part in a 60-90 minute, one-on-one session using the Zoom video conference platform and completing a brief online questionnaires.
• Completing an approximately 10 minute follow-up questionnaire online with a brief phone call 4, and 8 weeks after the education session. An additional optional insomnia questionnaire will be requested at one month after the 8 week follow-up.
• Participants will receive a $25 gift card upon completing 4 & 8 week questionnaires.

It expected that about 70 people will take part in this study.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Dana Farber Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age 40-89
• 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
• Regular access to the internet on a daily basis
• 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 diagnosed with sleep apnea who have declined treatment or are not adherent with treatment (as assessed by screening questions, see Appendix A).
• Survivors with suspected sleep apnea who have not completed an evaluation by a sleep specialist (as assessed by screening questions, see Appendix A).
• 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: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sleep Treatment Education Program (STEP-1); Prior to being randomized, all participants will complete health questionnaires. Participants assigned to the Sleep Treatment Education Program (STEP-1) group will receive online instruction on making changes to sleep habits and health behaviors. Participants will be contacted at 1 month and 2 months after the education session to complete follow up online questionnaires.	Behavioral: Sleep Treatment Education Program (STEP-1); Video conference instruction on behavioral changes to improve sleep.
Active Comparator: Enhanced Usual Care: Relaxation Education; Prior to being randomized, all participants will complete health questionnaires. Participants assigned to the Enhanced Usual Care group will receive information on relaxation techniques to improve sleep Participants will be contacted at 1 month and 2 months after the education session to complete follow up online questionnaires.	Behavioral: Enhanced Usual Care; Video conference instruction on relaxation techniques to improve sleep.

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

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
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
Change in Sleep Quality	The PROMIS Sleep Disturbance Short Form 8b (PROMIS-SD) is an 8 item scale used to assess sleep disturbances and their impact on overall sleep quality. Items include specific sleep problems (e.g., restless sleep) as well as satisfaction with sleep quality and amount of sleep. Item responses are summed to calculate a Total score, with raw scores (range 8-40) translated into t-scores (mean = 50, SD= 10). Higher PROMIS-SD Total t-scores indicate greater levels of sleep disturbance.	Baseline to 8 Weeks
Sleep Duration	Total sleep time in hours per night calculated from the Consensus Sleep Diary-Morning	Administered at 8 week follow-up
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intervention Session Usability & Satisfaction	Study specific participant checklist describing ease of use, acceptability and credibility of intervention	Up to 4 weeks post-intervention
Intervention Satisfaction Summary	Brief participant questionnaire to provide feedback about the intervention and how it could be improved.	Completed at the 8-week post-intervention timepoint
Coaching Satisfaction Summary	Brief participant questionnaire to provide feedback about coaching session. could be improved.	Up to 13 weeks post-intervention
Insomnia Symptoms at 16 Weeks (Optional)	After completing 8-week follow-up, participants will be asked if they are willing to complete one additional Insomnia Severity Scale 8 weeks later.	At 16 weeks post-intervention

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Bice BL, Michaud AL, McCormick KG, Miklos EM, Descombes ID, Medeiros-Nancarrow C, Zhou ES, Recklitis CJ. Sleep Treatment Education Program for Cancer Survivors: Protocol for an Efficacy Trial. JMIR Res Protoc. 2024 Nov 28;13:e60762. doi: 10.2196/60762.

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2023
• Primary Completion (Actual): October 11, 2024
• Study Completion (Actual): October 11, 2024

Study Registration Dates

• First Submitted: August 26, 2022
• First Submitted That Met QC Criteria: August 26, 2022
• First Posted (Actual): August 29, 2022

Study Record Updates

• Last Update Posted (Actual): February 2, 2026
• Last Update Submitted That Met QC Criteria: January 30, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Insomnia; Cancer Survivors
• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: 20-516; 1R21CA267857 (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