Clinical trial · Interventional
Sleep Treatment Education Program-1 (STEP-1)
Sleep Treatment Education Program (STEP-1): An Online Educational Intervention for Insomnia in Cancer Survivors
NCT05519982CI-TRIAL-00102147completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of the study is to learn if single session online education programs can help improve cancer survivors' sleep.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer Survivors | — | UNRESOLVED | — |
| Insomnia | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Enhanced Usual Care | Behavioral | — | UNRESOLVED |
| Sleep Treatment Education Program (STEP-1) | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Sleep Treatment Education Program (STEP-1)
- description
- 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.
- interventionNames
- Behavioral: Sleep Treatment Education Program (STEP-1)
- type
- ACTIVE_COMPARATOR
- label
- Enhanced Usual Care: Relaxation Education
- description
- 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.
- interventionNames
- Behavioral: Enhanced Usual Care
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
- Maximum age
- 89 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDBice 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 39608001