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NCT05358951 | Recruiting | Insomnia


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

Dana-Farber Cancer Institute

Information provided by (Responsible Party):

Christopher Recklitis, PhD

Brief Summary:

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).

Condition or disease

Insomnia

Insomnia Due to Medical Condition

Cancer

Intervention/treatment

STEP-YA with Coaching

STEP-YA without Coaching

Phase

Not Applicable

Detailed Description:

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

Study Type : Interventional
Estimated Enrollment : 74 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Sleep Treatment Education Program for Young Adult Cancer Survivors (STEP-YA): An Online Educational Intervention for Insomnia
Actual Study Start Date : November 19, 2022
Estimated Primary Completion Date : April 30, 2025
Estimated Study Completion Date : April 30, 2025
Arm Intervention/treatment

Active Comparator: NON-COACHING CONDITION STEP-YA

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

Experimental: COACHING CONDITION STEP-YA

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

Ages Eligible for Study: 20 Years to 39 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
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.

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

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

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


Recruiting

United States, Massachusetts

Dana-Farber Cancer Institute

Boston, Massachusetts, United States, 02215

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