Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
70 participants
INTERVENTIONAL
2023-03-10
2024-10-11
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Sleep Treatment Education Program (STEP-1)
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.
Sleep Treatment Education Program (STEP-1)
Video conference instruction on behavioral changes to improve sleep.
Enhanced Usual Care: Relaxation Education
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.
Enhanced Usual Care
Video conference instruction on relaxation techniques to improve sleep.
Interventions
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Sleep Treatment Education Program (STEP-1)
Video conference instruction on behavioral changes to improve sleep.
Enhanced Usual Care
Video conference instruction on relaxation techniques to improve sleep.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
40 Years
89 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Dana-Farber Cancer Institute
OTHER
Responsible Party
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Christopher Recklitis, PhD
Principal Investigator
Principal Investigators
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Christopher Recklitis, PhD, MPH
Role: PRINCIPAL_INVESTIGATOR
Dana-Farber Cancer Insitute
Locations
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Dana Farber Cancer Institute
Boston, Massachusetts, United States
Countries
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References
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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.
Other Identifiers
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20-516
Identifier Type: -
Identifier Source: org_study_id
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