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Completed

NCT Number: NCT05519982

Sleep Treatment Education Program-1 (STEP-1)

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

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Key information

Age range

40 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Sleep Treatment Education Program (STEP-1)

Behavioral

Video conference instruction on behavioral changes to improve sleep.

Enhanced Usual Care

Behavioral

Video conference instruction on relaxation techniques to improve sleep.

Primary outcomes

  1. Insomnia Severity Change at 8 Weeks

    Time frame: Baseline to 8 weeks

    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

    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

    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. Change in Sleep Quality

    Time frame: Baseline to 8 Weeks

    The PROMIS Sleep Disturbance Short Form 8b (PROMIS-SD) is an 8 item scale used to assess sleep disturbances and their impact on overall sleep quality. Items include specific sleep problems (e.g., restless sleep) as well as satisfaction with sleep quality and amount of sleep. Item responses are summed to calculate a Total score, with raw scores (range 8-40) translated into t-scores (mean = 50, SD= 10). Higher PROMIS-SD Total t-scores indicate greater levels of sleep disturbance.

  4. Sleep Duration

    Time frame: Administered at 8 week follow-up

    Total sleep time in hours per night calculated from the Consensus Sleep Diary-Morning

  5. Insomnia Severity Change at 4 Weeks

    Time frame: Baseline to 4 Weeks

    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. Intervention Session Usability & Satisfaction

    Time frame: Up to 4 weeks post-intervention

    Study specific participant checklist describing ease of use, acceptability and credibility of intervention

  2. Intervention Satisfaction Summary

    Time frame: Completed at the 8-week post-intervention timepoint

    Brief participant questionnaire to provide feedback about the intervention and how it could be improved.

  3. Coaching Satisfaction Summary

    Time frame: Up to 13 weeks post-intervention

    Brief participant questionnaire to provide feedback about coaching session. could be improved.

  4. Insomnia Symptoms at 16 Weeks (Optional)

    Time frame: At 16 weeks post-intervention

    After completing 8-week follow-up, participants will be asked if they are willing to complete one additional Insomnia Severity Scale 8 weeks later.

Sponsors and collaborators

Lead sponsor

Dana-Farber Cancer Institute

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 29, 2022
Registry last updated
Feb 2, 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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