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Remote Genetic Counseling for Cancer Survivors (ENGAGE Trial)

N/A
Recruiting
Led By Angela Bradbury, MD
Research Sponsored by University of Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Childhood Cancer Survivor Study Participant survivors of CNS tumor, Sarcoma (except Ewing sarcoma), Hepatoblastoma, Leukemia
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 month status survey (arm c)
Awards & highlights

ENGAGE Trial Summary

This trial will test whether an adapted model of remote delivery of genetic services can increase uptake of genetic assessment and testing among childhood cancer survivors.

Who is the study for?
This trial is for childhood cancer survivors in the US who can communicate in English or Spanish and have a specific family history of cancer. They must be able to use remote communication tools but cannot join if they have severe communication issues, live where genetic counseling isn't licensed, or have conditions that prevent understanding of the study.Check my eligibility
What is being tested?
The study tests how effective remote telegenetic counseling by phone or videoconferencing is compared to usual care in encouraging childhood cancer survivors to take recommended genetic assessments and tests.See study design
What are the potential side effects?
Since this trial involves counseling services rather than medical treatments, traditional side effects are not applicable. However, participants may experience emotional or psychological responses from discussing their genetic risks.

ENGAGE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I survived a CNS tumor, Sarcoma (not Ewing's), Hepatoblastoma, or Leukemia as a child.

ENGAGE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 month status survey (arm c)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 month status survey (arm c) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Genetic Knowledge Scale
Impact of Events Scale (IES)
Number of participants who received testing or genetic counseling
+1 more
Secondary outcome measures
Change in Health Behaviors (Selected from the Behavioral Risk Factor Surveillance System Questionnaire and the Health and Diet survey Dietary Guidelines Supplement)
Malignant Neoplasms
Patient Reported Outcomes Measurement Information Systems (PROMIS)
+1 more

ENGAGE Trial Design

3Treatment groups
Experimental Treatment
Group I: USUAL CARE (ARM C)Experimental Treatment1 Intervention
Usual Care: Participants will receive referrals to genetic counseling providers, initiating services on their own. At 6 months, if participants have not sought and received genetic counseling services, they will be offered randomization to ARM A/ARM B.
Group II: Remote Telegenetics: VIDEOCONFERENCING (ARM B)Experimental Treatment1 Intervention
Remote Videoconferencing Telegenetics: Participants with complete pre-test and disclosure counseling with a Genetic Counselor using remote services - VIDEOCONFERENCING.
Group III: Remote Telegenetics: TELEPHONE (ARM A)Experimental Treatment1 Intervention
Remote Phone Telegenetics: Participants with complete pre-test and disclosure counseling with a Genetic Counselor using remote services - TELEPHONE.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Usual Care Arm
2020
N/A
~1040

Find a Location

Who is running the clinical trial?

National Institutes of Health (NIH)NIH
2,682 Previous Clinical Trials
6,930,348 Total Patients Enrolled
University of ChicagoLead Sponsor
997 Previous Clinical Trials
817,248 Total Patients Enrolled
University of PennsylvaniaOTHER
1,993 Previous Clinical Trials
42,875,113 Total Patients Enrolled

Media Library

Remote Telegenetic Counseling by Phone Clinical Trial Eligibility Overview. Trial Name: NCT04455698 — N/A
Remote Telegenetic Counseling by Phone 2023 Treatment Timeline for Medical Study. Trial Name: NCT04455698 — N/A
Cancer Research Study Groups: Remote Telegenetics: VIDEOCONFERENCING (ARM B), Remote Telegenetics: TELEPHONE (ARM A), USUAL CARE (ARM C)
Cancer Clinical Trial 2023: Remote Telegenetic Counseling by Phone Highlights & Side Effects. Trial Name: NCT04455698 — N/A

Frequently Asked Questions

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

How many participants are registering for this trial?

"Affirmative. Clinicaltrials.gov indicates that this research has been listed since August 16th 2021 and is currently seeking 450 participants from 3 different clinical sites as of March 10th 2022."

Answered by AI

What results is this clinical experiment hoping to yield?

"This research study, which will last for 6 months in ARM C, monitors the Genetic Knowledge Scale as its primary outcome. Secondary objectives include measuring changes to Patient Reported Outcome Measurement Information Systems (PROMIS) Anxiety levels, patient uptake of genetic counseling and testing services, and changes to health behaviours derived from Behavioral Risk Factor Surveillance System Questionnaire & Health Diet Survey Dietary Guidelines Supplement surveys."

Answered by AI

Is there still availability for individuals to participate in this research?

"Confirmed, this clinical trial is currently open for recruitment. It was initially published on August 16th 2021 and the latest update took place on March 10th 2022."

Answered by AI
~126 spots leftby Mar 2025