MyCancerGene App for Cancer Genetic Testing Outcomes

(MyCancerGene Trial)

Recruiting in Philadelphia (>99 mi)

Overseen By Angela R Bradbury, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Abramson Cancer Center of the University of Pennsylvania

Disqualifiers: No internet access

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

Compensation: Varies

Number of Visits: Unknown

400 Participants Needed

Trial Summary

What is the purpose of this trial?

This protocol aims to evaluate the efficacy of a theoretically and stakeholder informed patient-centered genetic Interactive Health Communication Application to increase patient understanding of, and affective and behavioral responses to genetic testing. The study investigators hypothesize that the intervention will be associated with increases in knowledge, decreases in distress, increases in communication with relatives and health care providers, and increases in performance of risk reducing health behaviors.

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 MyCancerGene?

The research highlights the use of digital tools like MyLynch and GUÍA, which help patients understand genetic testing results and make informed decisions about their cancer risks. These tools show that personalized medicine and genetic counseling can improve patient outcomes by providing tailored information and interventions, suggesting that similar approaches could support the effectiveness of MyCancerGene. ^{1 2 3 4 5}

How does the MyCancerGene treatment differ from other treatments for cancer genetic testing outcomes?

The MyCancerGene treatment is unique because it uses a web-based app to automate parts of genetic counseling for cancer risk, making it easier and faster for patients to access genetic testing information without needing a specialist. This approach addresses the shortage of trained genetics providers and streamlines the process for patients. ^{1 5 6 7 8}

Research Team

Angela Bradbury, MD

Principal Investigator

University of Pennsylvania

Eligibility Criteria

This trial is for men and women over 18 who have had genetic counseling and testing for hereditary cancer syndromes within the last 60 days. Participants must speak English and have access to the internet or a mobile device.

Inclusion Criteria

I am either male or female.

Internet and/or mobile access

I am 18 years old or older.

Exclusion Criteria

No internet and/or mobile access

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive access to the MyCancerGene application to improve understanding and communication of genetic testing results

12 months

Follow-up

Participants are monitored for changes in knowledge, distress, communication, and health behaviors

6 months

Treatment Details

Interventions

• MyCancerGene

Trial Overview The trial is testing 'MyCancerGene,' an interactive health application designed to improve patient understanding of genetic testing results, reduce distress, encourage communication with family and healthcare providers, and promote risk-reducing behaviors.

Participant Groups

Group I: Intervention Group Experimental Treatment 1 Intervention

Individuals randomized to this arm will receive immediate access to the Interactive Health Communication Application.

Group II: Usual Care Group Active Control 1 Intervention

Individuals randomized to this arm will receive the standard clinical practice.

Who Is Running the Clinical Trial?

Abramson Cancer Center of the University of Pennsylvania

Lead Sponsor

Trials

360

Recruited

108,000+

Abramson Cancer Center at Penn Medicine

Lead Sponsor

Trials

425

Recruited

464,000+

American Cancer Society, Inc.

Collaborator

Trials

237

Recruited

110,000+

Findings from Research

The study developed an automated algorithmic pipeline that efficiently identifies patients eligible for precision medicine clinical trials based on genetic biomarkers, addressing the time-consuming and inconsistent manual processes currently used by healthcare providers.

This algorithm was successfully applied to patients at the Stanford Cancer Center, demonstrating its feasibility and accuracy as an effective alternative to traditional methods of clinical trial curation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Increasing Clinical Trial Accrual via Automated Matching of Biomarker Criteria. Chen, JW., Kunder, CA., Bui, N., et al.[2022]

The GUÍA web-based platform significantly improved parents' perceived understanding of genetic test results, with participants in the GUÍA arm reporting a 2.8 times higher understanding compared to standard care, based on a study involving 551 participants.

Hispanic/Latino(a) participants using GUÍA showed even greater benefits, with a 3.9 times higher perceived understanding and improved confidence in explaining results, highlighting the platform's effectiveness in diverse populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The NYCKidSeq randomized controlled trial: Impact of GUÍA digitally enhanced genetic counseling in racially and ethnically diverse families. Suckiel, SA., Kelly, NR., Odgis, JA., et al.[2023]

A web-based educational tool significantly increased knowledge and feelings of empowerment regarding genetic testing among 305 patients, regardless of their health literacy levels, indicating its effectiveness in educating patients before genetic counseling.

The tool may help address the shortage of trained genetic providers by streamlining the delivery of genetic services, as it was shown to enhance patient understanding without altering attitudes towards testing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Web-Based Tool to Automate Portions of Pretest Genetic Counseling for Inherited Cancer. Cragun, D., Weidner, A., Tezak, A., et al.[2021]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

MyLynch: A Patient-Facing Clinical Decision Support Tool for Genetically-Guided Personalized Medicine in Lynch Syndrome. [2023]

2. Australia pubmed.ncbi.nlm.nih.gov

Universal genetic testing for women with newly diagnosed breast cancer in the context of multidisciplinary team care. [2023]

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

Increasing Clinical Trial Accrual via Automated Matching of Biomarker Criteria. [2022]

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

The NYCKidSeq randomized controlled trial: Impact of GUÍA digitally enhanced genetic counseling in racially and ethnically diverse families. [2023]

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

A Web-Based Tool to Automate Portions of Pretest Genetic Counseling for Inherited Cancer. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Clinical software development for the Web: lessons learned from the BOADICEA project. [2021]

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

gene.iobio: an interactive web tool for versatile, clinically-driven variant interrogation and prioritization. [2022]

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

Clinical genomicist workstation. [2020]