N/A
N=70
Sleep Treatment Education Program-1 (STEP-1)
Cancer Survivors · Insomnia
Bottom Line
View on ClinicalTrials.gov: NCT05519982 ↗Enrolled (actual)
70
Serious AEs
0.0%
Results posted
Feb 2026
Primary outcome: Primary: Insomnia Severity Change at 8 Weeks — 7.3; 9.5 Units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Sleep Treatment Education Program (STEP-1) (Behavioral); Enhanced Usual Care (Behavioral)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Dana-Farber Cancer Institute
- Primary completion
- Oct 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Insomnia Severity Change at 8 Weeks |
7.3; 9.5 | — |
| SECONDARY Profile of Mood States Change at 8 Weeks |
.85; 4.2 | — |
| SECONDARY Profile of Mood States Change at 4 Weeks |
3.4; 6.4 | — |
| SECONDARY Change in Sleep Quality |
52.2; 53.1 | — |
| SECONDARY Sleep Duration |
7.0; 7.3 | — |
| SECONDARY Insomnia Severity Change at 4 Weeks |
8.6; 11.7 | — |
Summary
The purpose of the study is to learn if single session online education programs can help improve cancer survivors' sleep.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT05519982). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.