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STEP-YA for Sleep Disorders in Cancer Survivors

N/A
Recruiting
Led By Christopher J Recklitis, PhD, MPH
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
No active cancer therapy (excluding chemoprevention) in the past four months, and no further therapy planned
Age 20-39
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 16 weeks post-intervention session
Awards & highlights

Study Summary

This trial is exploring if an online education session on sleep, with or without coaching, can help improve the sleep of young adult cancer survivors. The name of the study is Sleep Treatment Education Program for Young Adult Cancer Survivors (STEP-YA).

Who is the study for?
This trial is for young adult cancer survivors aged 20-39 who have been cancer-free and off active therapy for at least four months. They must be experiencing significant insomnia, able to read/write in English, and diagnosed with cancer over a year ago. Exclusions include bipolar or seizure disorders, untreated sleep apnea, irregular sleep patterns due to work, recent insomnia treatments, or plans to change medications affecting sleep.Check my eligibility
What is being tested?
The STEP-YA program aims to improve the sleep of young adult cancer survivors through an online education session. The study compares the effectiveness of this session alone versus the session combined with individualized coaching sessions.See study design
What are the potential side effects?
As STEP-YA involves educational content and possibly coaching sessions without medication or invasive procedures, no direct side effects are expected from participating in this trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I haven't had cancer treatment in the last 4 months and don't plan to have more.
Select...
I am between 20 and 39 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~16 weeks post-intervention session
This trial's timeline: 3 weeks for screening, Varies for treatment, and 16 weeks post-intervention session for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Insomnia Severity Change at 8 Weeks
Secondary outcome measures
Insomnia Severity Change at 4 weeks
Profile of Mood States Change at 4 weeks
Profile of Mood States Change at 8 weeks
Other outcome measures
Final satisfaction with the intervention
Initial Satisfaction with Intervention Session
Insomnia Severity at 16 weeks (optional)
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: COACHING CONDITION STEP-YAExperimental Treatment1 Intervention
Participants will receive a single online education session and complete online questionnaire then be randomized to receive 2 individualized remote coaching sessions. Participates will also complete follow up questionaires at 4 and 8 weeks post baseline.
Group II: NON-COACHING CONDITION STEP-YAActive Control1 Intervention
Participants will receive a single online education session and complete online questionnaires then be randomized to not receive additional coaching support sessions. Participates will also complete follow up questionaires at 4 and 8 weeks post baseline.

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteLead Sponsor
1,077 Previous Clinical Trials
340,669 Total Patients Enrolled
6 Trials studying Insomnia
490 Patients Enrolled for Insomnia
National Cancer Institute (NCI)NIH
13,627 Previous Clinical Trials
40,927,761 Total Patients Enrolled
10 Trials studying Insomnia
1,921 Patients Enrolled for Insomnia
Christopher J Recklitis, PhD, MPHPrincipal InvestigatorDana-Farber Cancer Institute

Media Library

STEP-YA with Coaching Clinical Trial Eligibility Overview. Trial Name: NCT05358951 — N/A
Insomnia Research Study Groups: NON-COACHING CONDITION STEP-YA, COACHING CONDITION STEP-YA
Insomnia Clinical Trial 2023: STEP-YA with Coaching Highlights & Side Effects. Trial Name: NCT05358951 — N/A
STEP-YA with Coaching 2023 Treatment Timeline for Medical Study. Trial Name: NCT05358951 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the age of consent for this research limited to those over twenty years old?

"This clinical trial is exclusively seeking applicants between the ages of 20 to 39. There are 85 trials available for minors, and 608 studies open to individuals over 65 years old."

Answered by AI

Could I potentially qualify for participation in this research?

"This clinical trial seeks to recruit 74 individuals between the ages of 20 and 39 who have been previously diagnosed with cancer (with the exception of non-melanoma skin cancer). Eligibility is confirmed through patient self-report and screening materials in Appendix A. The timeframe for eligibility assessment must be within 2 weeks prior to study enrolment, or participants require a reevaluation if assessed earlier. In addition, these patients should demonstrate significant insomnia via an Insomnia Severity Index score ≥12, possess proficiency in English language reading and writing skills, as well as not having received any active therapy for their malignancy four months before enrollment or"

Answered by AI

Is there an opportunity to enroll in this scientific experiment at present?

"Affirmative. The clinicaltrials.gov website reveals that this medical experiment is still recruiting participants, with the first posting made on December 30th 2022 and a more recent update from October 24th 2022. Right now 74 patients need to be recruited at one clinic site."

Answered by AI

How many participants are currently engaged in this research project?

"Affirmative. According to the clinicaltrials.gov website, this clinical trial is actively seeking participants and was originally posted on December 30th 2022. The most recent update occurred on October 24th 2022 with a goal of recruiting 74 patients from 1 site."

Answered by AI
~33 spots leftby Apr 2025