Clinical trial NCT05358951: Sleep Treatment Education Program for Young Adult Cancer Survivors (STEP-YA)
Official title: Sleep Treatment Education Program for Young Adult Cancer Survivors (STEP-YA): An Online Educational Intervention for Insomnia
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Insomnia
Insomnia Due to Medical Condition
Cancer
Keywords: Insomnia
Insomnia Due to Medical Condition
Cancer
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2022-05-03
Enrollment: 56
Sex: ALL
Minimum age (years): 20
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

Detailed 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

Eligibility criteria: 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.

Primary outcomes:
measure: Insomnia Severity Change at 8 Weeks
timeFrame: Baseline to 8-weeks post-intervention session
Secondary outcomes:
measure: Profile of Mood States Change at 8 weeks
timeFrame: Baseline to 8-weeks post-intervention session
measure: Profile of Mood States Change at 4 weeks
timeFrame: Baseline to 4-weeks post-intervention session
measure: Insomnia Severity Change at 4 weeks
timeFrame: Baseline to 4-weeks post-intervention session
Other outcomes:
measure: Insomnia Severity at 16 weeks (optional)
timeFrame: 16 weeks post-intervention session
measure: Initial Satisfaction with Intervention Session
timeFrame: Up to 4 weeks post-intervention
measure: Satisfaction with Coaching Sessions
timeFrame: Up to 4 weeks post-intervention
measure: Final satisfaction with the intervention
timeFrame: 8 Weeks post-intervention session
Locations:
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Christopher J Recklitis, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: