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N/A N=70 Randomized Supportive Care

Sleep Treatment Education Program-1 (STEP-1)

Cancer Survivors · Insomnia

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

OutcomeResultp-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.
View full record on ClinicalTrials.gov →

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.

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