Clinical trial NCT05519982: Sleep Treatment Education Program-1 (STEP-1)
Official title: Sleep Treatment Education Program (STEP-1): An Online Educational Intervention for Insomnia in Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer Survivors
Insomnia
Keywords: Cancer Survivors
Insomnia
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2022-08-29
Enrollment: 70
Sex: ALL
Minimum age (years): 40
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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

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.

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.

Primary outcomes:
measure: Insomnia Severity Change at 8 weeks
timeFrame: Baseline to 8 weeks
Secondary outcomes:
measure: Profile of Mood States Change at 8 Weeks
timeFrame: Baseline to 8 weeks
measure: Profile of Mood States Change at 4 Weeks
timeFrame: Baseline to 4 weeks
measure: Change in Sleep Quality
timeFrame: Baseline to 8 Weeks
measure: Sleep Duration and Disruptions
timeFrame: Administered at 8 week follow-up
measure: Insomnia Severity Change at 4 weeks
timeFrame: Baseliine to 4 Weeks
Other outcomes:
measure: Intervention Session Usability & Satisfaction
timeFrame: Up to 4 weeks post-intervention
measure: Intervention Satisfaction Summary
timeFrame: Completed at the 8-week post-intervention timepoint
measure: Coaching Satisfaction Summary
timeFrame: Up to 13 weeks post-intervention
measure: Insomnia Symptoms at 16 Weeks (optional)
timeFrame: At 16 weeks post-intervention
Locations:
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Insitute
name: Christopher Recklitis, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: