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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05519982
Other study ID # 20-516
Secondary ID 1R21CA267857
Status Recruiting
Phase N/A
First received
Last updated
Start date March 10, 2023
Est. completion date January 30, 2025

Study information

Verified date March 2024
Source Dana-Farber Cancer Institute
Contact STEP-1 Sudy Coordinator
Phone 617-582-8260
Email step@dfci.harvard.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 70
Est. completion date January 30, 2025
Est. primary completion date August 28, 2024
Accepts healthy volunteers No
Gender All
Age group 40 Years to 89 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Sleep Treatment Education Program (STEP-1)
Video conference instruction on behavioral changes to improve sleep.
Enhanced Usual Care
Video conference instruction on relaxation techniques to improve sleep.

Locations

Country Name City State
United States Dana Farber Cancer Institute Boston Massachusetts

Sponsors (2)

Lead Sponsor Collaborator
Dana-Farber Cancer Institute National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Intervention Session Usability & Satisfaction Study specific participant checklist describing ease of use, acceptability and credibility of intervention Up to 4 weeks post-intervention
Other Intervention Satisfaction Summary Brief participant questionnaire to provide feedback about the intervention and how it could be improved. Completed at the 8-week post-intervention timepoint
Other Coaching Satisfaction Summary Brief participant questionnaire to provide feedback about coaching session. could be improved. Up to 13 weeks post-intervention
Other Insomnia Symptoms at 16 Weeks (optional) After completing 8-week follow-up, participants will be asked if they are willing to complete one additional Insomnia Severity Scale 8 weeks later. At 16 weeks post-intervention
Primary 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
Secondary 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
Secondary 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
Secondary Change in Sleep Quality The 8-item PROMIS-SD will be used to assess sleep disturbances and their impact on sleep quality Baseline to 8 Weeks
Secondary Sleep Duration and Disruptions 9 items from the Consensus Sleep Diary-Morning will be used to assess daily sleep timing, sleep latency and awakenings. Administered at 8 week follow-up
Secondary 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. Baseliine to 4 Weeks
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