Remote Genetic Counseling for Cancer Survivors

(ENGAGE Trial)

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

545 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Remote Telegenetic Counseling by Phone and Videoconferencing for cancer survivors?

Research shows that telegenetic counseling, which includes phone and videoconferencing, is generally as effective as in-person counseling for cancer genetic counseling. Studies report high patient satisfaction, comparable trust and rapport, and reduced costs and travel time, making it a viable option for those in underserved areas. ^{1 2 3 4 5}

Is remote genetic counseling safe for cancer survivors?

Research shows that remote genetic counseling, whether by phone or video, is generally safe and well-accepted by patients. Studies report high patient satisfaction and comparable outcomes to in-person counseling, with no significant safety concerns noted. ^{1 3 4 6 7}

How is Remote Telegenetic Counseling unique compared to other treatments for cancer survivors?

Remote Telegenetic Counseling is unique because it provides genetic counseling through phone or video calls, making it accessible to people in remote areas or those unable to attend in-person sessions. This approach has been shown to be effective and well-accepted, offering a convenient alternative to traditional face-to-face counseling. ^{1 4 6 8 9}

What is the purpose of this trial?

To address the gap in access to genetic services, this study will evaluate the effectiveness of an adapted model of remote delivery of genetic services to increase the uptake of recommended genetic assessment and testing in childhood cancer survivors.

Research Team

Tara Henderson, MD, MPH

Principal Investigator

University of Chicago

Angela Bradbury, MD

Principal Investigator

University of Pennsylvania

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Are videoconferenced consultations as effective as face-to-face consultations for hereditary breast and ovarian cancer genetic counseling? [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Randomized Trial of Telegenetics vs. In-Person Cancer Genetic Counseling: Cost, Patient Satisfaction and Attendance. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Telehealth for genetic counseling: A systematic evidence review. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

The virtual consultation: practitioners' experiences of genetic counseling by videoconferencing in Australia. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Examination of the Patient-Focused Impact of Cancer Telegenetics Among a Rural Population: Comparison with Traditional In-Person Services. [2021]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Rapid Implementation of Telegenetic Counseling in the COVID-19 and Swedish Healthcare Context: A Feasibility Study. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Comparison of Telephone and Televideo Modes for Delivery of Genetic Counseling: a Randomized Trial. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Telegenetics: an Update on Availability and Use of Telemedicine in Clinical Genetics Service. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

Telegenetics: Remote Counseling During the COVID-19 Pandemic. [2020]