Remote Genetic Counseling for Cancer Survivors

(ENGAGE Trial)

Not currently recruiting at 2 trial locations

Overseen By Mary A Allen

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Chicago

Disqualifiers: Uncontrolled psychiatric, Severe cognitive, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests remote genetic counseling to determine its effectiveness in helping childhood cancer survivors access necessary genetic services. Participants will either speak with a genetic counselor by phone (Remote Telegenetic Counseling by Phone) or through videoconferencing (Remote Telegenetic Counseling by Videoconferencing), or they will continue with their usual care and may later switch to one of the remote options. The trial seeks childhood cancer survivors or those with a family history of childhood cancer who can communicate in English or Spanish and are comfortable using remote communication tools. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance access to genetic counseling for many.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that remote telegenetic counseling is safe for cancer survivors?

Research has shown that remote genetic counseling, via phone or video, is generally safe and well-liked by patients. Studies report high patient satisfaction and outcomes similar to in-person meetings. For both phone and video options, patients reported positive experiences. No major safety issues emerged. Overall, these remote methods appear well-received, suggesting they are a safe choice for genetic counseling. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Remote Genetic Counseling trial because it explores innovative ways to deliver genetic counseling to cancer survivors through telegenetic methods. Unlike traditional in-person counseling, these remote options—via phone and videoconferencing—offer greater accessibility and convenience, especially for those who may have difficulty traveling to appointments. This trial could reveal whether these remote methods are as effective as face-to-face interactions, potentially transforming how genetic counseling services are provided by making them more reachable and efficient for patients.

What evidence suggests that this trial's remote telegenetic counseling treatments could be effective for cancer survivors?

This trial will compare different methods of delivering genetic counseling to cancer survivors. Participants may receive Remote Telegenetic Counseling by Phone or by Videoconferencing. Studies have shown that genetic counseling over the phone or through video calls is as effective as in-person meetings for cancer-related genetic services. Research indicates that people are equally satisfied with remote counseling as with face-to-face sessions. Both phone and video methods effectively ensure patients receive necessary genetic assessments and tests. This approach makes it easier for individuals, especially those who find attending in-person sessions challenging, to access important genetic services. Overall, evidence supports that remote methods can reliably help cancer survivors understand and manage their genetic health. ^{1 4 6 7 8}

Who Is on the Research Team?

Angela Bradbury, MD

Principal Investigator

University of Pennsylvania

Tara O Henderson, MD, MPH

Principal Investigator

University of Chicago

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I survived a CNS tumor, Sarcoma (not Ewing's), Hepatoblastoma, or Leukemia as a child.

Able to communicate remotely through remote telegenetic platforms (phone or videoconference) with genetic counselors

I am a childhood cancer survivor with a significant family history of cancer.

Exclusion Criteria

Uncorrected or uncompensated speech defects that would lead to the participant being unable to communicate effectively with genetic counselor

Currently residing in a US state or territory where genetic counselors are not licensed to provide care

I have completed genetic testing for my condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive remote telegenetic services, including pre-test and disclosure counseling with a Genetic Counselor via videoconferencing or telephone

6 months

Follow-up

Participants are monitored for changes in genetic knowledge, anxiety, depression, and uptake of genetic counseling and testing

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Remote Telegenetic Counseling by Phone
• Remote Telegenetic Counseling by Videoconferencing
• Usual Care Arm

Trial Overview 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.

How Is the Trial Designed?

Group I: USUAL CARE (ARM C) Experimental Treatment 1 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 Treatment 1 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 Treatment 1 Intervention

Remote Phone Telegenetics: Participants with complete pre-test and disclosure counseling with a Genetic Counselor using remote services - TELEPHONE.

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials

1,086

Recruited

844,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

University of Pennsylvania

Collaborator

Trials

2,118

Recruited

45,270,000+

St. Jude Children's Research Hospital

Collaborator

Trials

451

Recruited

5,326,000+

Fox Chase Cancer Center

Collaborator

Trials

236

Recruited

39,300+

Published Research Related to This Trial

Telegenetics, a telehealth tool for online genetic counseling, is gaining popularity as it improves access to genetic services, especially in remote areas, and addresses the shortage of clinical geneticists.

Live videoconference consultations in telegenetics are well accepted by both patients and clinicians, suggesting that this method can effectively meet the growing demand for personalized genomic medicine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telegenetics: an Update on Availability and Use of Telemedicine in Clinical Genetics Service. Vrečar, I., Hristovski, D., Peterlin, B.[2018]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04455698

Engaging and Activating Cancer Survivors in Genetic ... Our primary outcome will be a composite variable indicating whether a person had pre-test counseling or genetic testing. To evaluate the effectiveness of remote ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10900774/

The ENGAGE study: a 3-arm randomized hybrid type 1 ... The goal of the ENGAGE study is to evaluate the effectiveness of our in-home, collaborative PCP model of remote telegenetic services to increase ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12102641/

Patient‐reported outcomes for remote and in‐person visits ... Patient satisfaction with GC did not differ between visit modalities. For initial visits, telehealth satisfaction was higher for visits ...

4. withpower.com withpower.com/trial/phase-7-2021-f9278

Remote Genetic Counseling for Cancer Survivors · Info ... Research shows that telegenetic counseling, which includes phone and videoconferencing, is generally as effective as in-person counseling for cancer genetic ...

5. medrxiv.org medrxiv.org/content/10.1101/2025.10.20.25338173v1.full.pdf

A Randomized Trial Optimizing Uptake of Germline Cancer ... This study has several strengths, including being the largest randomized trial studying remote genetic services in childhood cancer survivors, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11953582/

Cancer genetic counseling via telegenetics and telephone This cohort expressed overall positive experiences adding to existing data showing that telegenetics and telephone are suitable modes of delivery for genetic ...

7. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/cam4.3968

Randomized study of remote telehealth genetic services ... Other studies have shown equal patient reported outcomes but lower uptake of remote telehealth (predominately phone) services when compared to ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S1098360021050589

a systematic review of telegenetics in light of the COVID-19 ... Patient satisfaction, genetic knowledge, and psychosocial outcomes were similar for in-person and telegenetic counseling. There was some evidence that ...