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Completed

NCT Number: NCT05358951

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

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).

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Key information

Age range

20 year–39 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

STEP-YA with Coaching

Behavioral

Online instruction on behavioral changes to improve sleep with 2 additional individually coached session

STEP-YA without Coaching

Behavioral

Online instruction on behavioral changes to improve sleep without additional individually coached session

Primary outcomes

  1. Insomnia Severity Change at 8 Weeks

    Time frame: Baseline to 8-weeks post-intervention session

    The Insomnia Severity Index (ISI) is a 7-item measure used to evaluate insomnia severity (e.g. dissatisfaction with sleep and worry about sleep problems). Item response values are totaled to calculate a total ISI score ranging from 0-28, with higher scores indicating more insomnia symptom burden.

Secondary outcomes

  1. Profile of Mood States Change at 8 Weeks

    Time frame: Baseline to 8-weeks post-intervention session

    The Profile of Mood States-Short Form (POMS-SF) is a 35-item measure of mood. Items responses are totaled to calculate scores on 7 subscales: Anger-Hostility, Confusion-Bewilderment, Depression-Dejection, Fatigue-Inertia, Tension-Anxiety, Vigor-Activity, and Friendliness. The Total Mood Disturbance (TMD) score used in the study is calculated by adding together the scores of 5 subscales, Anger-Hostility, Confusion-Bewilderment, Depression-Dejection, Fatigue-Inertia, Tension-Anxiety, then subtracting the score from the Vigor-Activity subscale. TMD scores range from -20 to 100 with higher scores indicating greater impairment.

  2. Profile of Mood States Change at 4 Weeks

    Time frame: Baseline to 4-weeks post-intervention session

    The Profile of Mood States-Short Form (POMS-SF) is a 35-item measure of mood. Items responses are totaled to calculate scores on 7 subscales: Anger-Hostility, Confusion-Bewilderment, Depression-Dejection, Fatigue-Inertia, Tension-Anxiety, Vigor-Activity, and Friendliness. The Total Mood Disturbance (TMD) score used in the study is calculated by adding together the scores of 5 subscales, Anger-Hostility, Confusion-Bewilderment, Depression-Dejection, Fatigue-Inertia, Tension-Anxiety, then subtracting the score from the Vigor-Activity subscale. TMD scores range from -20 to 100 with higher scores indicating greater impairment.

  3. Insomnia Severity Change at 4 Weeks

    Time frame: Baseline to 4-weeks post-intervention session

    The Insomnia Severity Index (ISI) is a 7-item measure used to evaluate insomnia severity (e.g. dissatisfaction with sleep and worry about sleep problems). Item response values are totaled to calculate a total ISI score ranging from 0-28, with higher scores indicating more insomnia symptom burden.

Other outcomes

  1. Insomnia Severity at 16 Weeks (Optional)

    Time frame: 16 weeks post-intervention session

    The Insomnia Severity Index (ISI) is a 7-item measure used to evaluate insomnia severity (e.g. dissatisfaction with sleep and worry about sleep problems). Item response values are totaled to calculate a total ISI score ranging from 0-28, with higher scores indicating more insomnia symptom burden.

  2. Initial Satisfaction With Intervention Session

    Time frame: Up to 4 weeks post-intervention

    Study specific questionnaire assessing intervention acceptability, credibility and participant satisfaction

  3. Satisfaction With Coaching Sessions

    Time frame: Up to 4 weeks post-intervention

    Study specific questionnaire describing satisfaction with coaching sessions

  4. Final Satisfaction With the Intervention

    Time frame: 8 Weeks post-intervention session

    Study specific questionnaire asking about participant satisfaction with the intervention

Sponsors and collaborators

Lead sponsor

Dana-Farber Cancer Institute

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
May 3, 2022
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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