Sleep Treatment Education Program for the Management of Insomnia in Young Adult Cancer Survivors, The STEP-YA Trial

Status: closed to accrual

This clinical trial tests the Sleep Treatment Education Program for Young Adult Cancer Survivors (STEP-YA) online intervention for the management of insomnia in young adults with a history of cancer. Young adult cancer survivors can experience significant insomnia even many years after cancer treatment. Long-term insomnia is associated with significant health problems, including heart disease, obesity, high blood pressure, diabetes, depression, and anxiety This sleep educational program addresses lifestyle issues (e.g., benefits of exercise and limiting alcohol), sleep environment (e.g., importance of a dark, quiet bedroom; avoiding bed for non-sleep activities), sleep timing (e.g., regular wake time, avoiding napping), and managing expectations and challenges (e.g., sleep worry, physical symptoms, social pressures). Combining this sleep education program along with personalized coaching sessions may help address insomnia issues and improve overall health of young adult cancer survivors.

Inclusion Criteria

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)
Survivors who report suspected sleep apnea who have not completed an evaluation by a sleep specialist (as assessed by screening questions)
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

PRIMARY OBJECTIVES:

I. To test the hypothesis that STEP-YA improves insomnia symptoms (primary outcome) and mood (secondary outcome) in young adult cancer survivors.

II. To determine if improvement in these outcomes are superior in the coaching condition compared to the non-coaching condition.

SECONDARY OBJECTIVE:

I. To explore participant factors associated with clinically significant response to the STEP-YA intervention.

OUTLINE: Participants are randomized to 1 of 2 arms.

ARM I: Participants participate in a single online STEP-YA educational session with a trained interventionist to develop a sleep action plan throughout the trial.

ARM II: Participants participate in a single online STEP-YA educational session with a trained interventionist to develop a sleep action plan, and then two individual remote coaching sessions with paraprofessional coaches throughout the trial.

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Sleep Treatment Education Program for the Management of Insomnia in Young Adult Cancer Survivors, The STEP-YA Trial

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