Sleep Treatment Education Program-1 (STEP-1)
2 other identifiers
interventional
70
1 country
1
Brief Summary
The purpose of the study is to learn if single session online education programs can help improve cancer survivors' sleep.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 26, 2022
CompletedFirst Posted
Study publicly available on registry
August 29, 2022
CompletedStudy Start
First participant enrolled
March 10, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 11, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
October 11, 2024
CompletedResults Posted
Study results publicly available
February 2, 2026
CompletedFebruary 2, 2026
January 1, 2026
1.6 years
August 26, 2022
December 11, 2025
January 30, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
Profile of Mood States Change at 8 Weeks
Baseline to 8 weeks
Profile of Mood States Change at 4 Weeks
Baseline to 4 weeks
Change in Sleep Quality
Baseline to 8 Weeks
Sleep Duration
Administered at 8 week follow-up
Insomnia Severity Change at 4 Weeks
Baseline to 4 Weeks
Other Outcomes (4)
Intervention Session Usability & Satisfaction
Up to 4 weeks post-intervention
Intervention Satisfaction Summary
Completed at the 8-week post-intervention timepoint
Coaching Satisfaction Summary
Up to 13 weeks post-intervention
- +1 more other outcomes
Study Arms (2)
Sleep Treatment Education Program (STEP-1)
EXPERIMENTALPrior 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.
Enhanced Usual Care: Relaxation Education
ACTIVE COMPARATORPrior 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.
Interventions
Video conference instruction on relaxation techniques to improve sleep.
Video conference instruction on behavioral changes to improve sleep.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Dana-Farber Cancer Institutelead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
Dana Farber Cancer Institute
Boston, Massachusetts, 02115, United States
Related Publications (1)
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.
PMID: 39608001DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Christopher Recklitis
- Organization
- Dana-Farber Cancer Institute
Study Officials
- PRINCIPAL INVESTIGATOR
Christopher Recklitis, PhD, MPH
Dana-Farber Cancer Insitute
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
August 26, 2022
First Posted
August 29, 2022
Study Start
March 10, 2023
Primary Completion
October 11, 2024
Study Completion
October 11, 2024
Last Updated
February 2, 2026
Results First Posted
February 2, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- 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
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.