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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05358951
• Other study ID #: 21-613
• Secondary ID: R21CA261863
• Status: Recruiting
• Phase: N/A
• Start date: November 19, 2022
• Est. completion date: April 30, 2025

Study information

• Verified date: March 2024
• Source: Dana-Farber Cancer Institute
• Contact: STEP-YA Study 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 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).

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 74
• Est. completion date: April 30, 2025
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 39 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cancer
• Insomnia
• Insomnia Due to Medical Condition
• Sleep Initiation and Maintenance Disorders

Intervention

Behavioral:
• STEP-YA with Coaching
Online instruction on behavioral changes to improve sleep with 2 additional individually coached session
• STEP-YA without Coaching
Online instruction on behavioral changes to improve sleep without additional individually coached session

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	Insomnia Severity at 16 weeks (optional)	The Insomnia Severity Index (ISI), a 7-item self-report questionnaire assessing severity, and impact of insomnia symptoms will be used.	16 weeks post-intervention session
Other	Initial Satisfaction with Intervention Session	Study specific questionnaire assessing intervention acceptability, credibility and participant satisfaction	Up to 4 weeks post-intervention
Other	Satisfaction with Coaching Sessions	Study specific questionnaire describing satisfaction with coaching sessions	Up to 4 weeks post-intervention
Other	Final satisfaction with the intervention	Study specific questionnaire asking about participant satisfaction with the intervention	8 Weeks post-intervention session
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 post-intervention session
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 post-intervention session
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 post-intervention session
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.	Baseline to 4-weeks post-intervention session