Sleep Treatment Education Program-1 (STEP-1)

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

Detailed Description
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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.

Official Title
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Sleep Treatment Education Program (STEP-1): An Online Educational Intervention for Insomnia in Cancer Survivors

Conditions
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Cancer Survivors, Insomnia

Intervention / Treatment
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* Behavioral: Sleep Treatment Education Program (STEP-1)
* Behavioral: Enhanced Usual Care


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sleep Treatment Education Program (STEP-1)<br>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. | Behavioral: Sleep Treatment Education Program (STEP-1)<br>* Video conference instruction on behavioral changes to improve sleep.<br>|
| Active Comparator: Enhanced Usual Care: Relaxation Education<br>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. | Behavioral: Enhanced Usual Care<br>* Video conference instruction on relaxation techniques to improve sleep.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insomnia Severity Change at 8 weeks | The Insomnia Severity Index (ISI), a 7-item self-report questionnaire assessing severity, and impact of insomnia symptoms will be used. | Baseline to 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Profile of Mood States Change at 8 Weeks | The Profile of Mood States - Short Form (POMS-SF), a 35-item measure of participant mood states that provides multiple scales including an overall Total Mood Disturbance (TMD) score will be used | Baseline to 8 weeks | 
| Profile of Mood States Change at 4 Weeks | The Profile of Mood States - Short Form (POMS-SF), a 35-item measure of participant mood states that provides multiple scales including an overall Total Mood Disturbance (TMD) score will be used | Baseline to 4 weeks | 
| Change in Sleep Quality | The 8-item PROMIS-SD will be used to assess sleep disturbances and their impact on sleep quality | Baseline to 8 Weeks | 
| Sleep Duration and Disruptions | 9 items from the Consensus Sleep Diary-Morning will be used to assess daily sleep timing, sleep latency and awakenings. | Administered at 8 week follow-up | 
| Insomnia Severity Change at 4 weeks | The Insomnia Severity Index (ISI), a 7-item self-report questionnaire assessing severity, and impact of insomnia symptoms will be used. | Baseliine to 4 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer Survivors, Insomnia