Sleep Treatment Education Program-1 (STEP-1)

Insomnia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05519982
• Other study ID #: 20-516
• Secondary ID: 1R21CA267857
• Status: Recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Cancer Survivors
• Insomnia
• Sleep Initiation and Maintenance Disorders

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