Sleep Treatment Education Program for Young Adult Cancer Survivors (STEP-YA)

Study Overview
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Brief Summary
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The purpose of the study is to learn if a single online education session, with or without individualized coaching sessions, can help improve young adult cancer survivors' (YACS) sleep. The name of the study intervention is Sleep Treatment Education Program for Young Adult Cancer Survivors (STEP-YA).

Detailed Description
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This study is a randomized controlled trial of young adult cancer survivors with clinically significant symptoms of insomnia to evaluate the cognitive-behavioral based Sleep Treatment Education Program for Young Adult Cancer Survivors (STEP-YA). All participants will take part in a single STEP-YA session, during which they will complete baseline measures prior to randomization and then receive the STEP-YA intervention. Participants will then be randomly assigned to receive the STEP-YA intervention either, 1) alone (non-coaching condition), or 2) with the addition of 2 remote coaching sessions (coaching condition). Participants will also complete follow-up measures 4 and 8 weeks post-baseline. It expected that about 74 people will take part in this study

Official Title
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Sleep Treatment Education Program for Young Adult Cancer Survivors (STEP-YA): An Online Educational Intervention for Insomnia

Conditions
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Insomnia, Insomnia Due to Medical Condition, Cancer

Intervention / Treatment
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* Behavioral: STEP-YA with Coaching
* Behavioral: STEP-YA without Coaching


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: To be determined by patient self-report from eligibility screening with potential participants. (See Appendix A for eligibility screening materials). Participants must be screened for eligibility ≤2 weeks prior to study enrollment. Participants who are screened earlier must be rescreened within this period. Age 20-39 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 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 who report being diagnosed with sleep apnea who are not receiving recommended medical treatment for their sleep apnea (as assessed by screening questions, see Appendix A). Survivors who report suspected sleep apnea who have not completed an evaluation by a sleep specialist (as assessed by screening questions, see Appendix A). Survivors who report their 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: 20 Years
Maximum Age: 39 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: NON-COACHING CONDITION STEP-YA<br>Participants will receive a single online education session and complete online questionnaires then be randomized to not receive additional coaching support sessions. Participates will also complete follow up questionaires at 4 and 8 weeks post baseline. | Behavioral: STEP-YA without Coaching<br>* Online instruction on behavioral changes to improve sleep without additional individually coached session<br>|
| Experimental: COACHING CONDITION STEP-YA<br>Participants will receive a single online education session and complete online questionnaire then be randomized to receive 2 individualized remote coaching sessions. Participates will also complete follow up questionaires at 4 and 8 weeks post baseline. | Behavioral: STEP-YA with Coaching<br>* Online instruction on behavioral changes to improve sleep with 2 additional individually coached session<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 post-intervention session | 

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 post-intervention session | 
| 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 post-intervention session | 
| 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. | Baseline to 4-weeks post-intervention session | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Insomnia, Insomnia Due to Medical Condition, Cancer