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A Randomized Study of an eHealth Delivery Alternative for Cancer Genetic Testing for Hereditary Predisposition in Metastatic Breast, Ovarian, Prostate and Pancreatic Cancer Patients (E-Reach)

A Randomized Study of an eHealth Delivery Alternative for Cancer Genetic Testing for Hereditary Predisposition in Metastatic Breast, Ovarian, Prostate and Pancreatic Cancer Patients (E-Reach)

Clinicaltrials.gov identifier:
NCT04353973

Treatment:
Breast, Ovarian, Pancreatic, Prostate

Study Contact Information:

If you have questions you can contact the study team at:

Dominique Fetzer by email

Lauren Gutstein by email


A Randomized Study of an eHealth Delivery Alternative for Cancer Genetic Testing for Hereditary Predisposition in Metastatic Breast, Ovarian, Prostate and Pancreatic Cancer Patients

About the Study

Genetic testing can be helpful to identify potential targeted treatments for some patients with metastatic cancer. But some patients have a hard time getting easy and fast testing. This study is looking at using web options to increase access to testing AND patients in this study can get genetic counseling and testing in their home! For more information visit  the E-Reach registration page

Type of Study

eReach is a randomized study. To be randomized means that individuals will have a 25% chance of being placed in any of the following four groups.

ARM

Pre-Test Session

Result Disclosure Session

ARM A

With a Genetic Counselor

With a Genetic Counselor

ARM B

With a Genetic Counselor

Using the Web-Based eHealth Tool

ARM C

Using the Web-Based eHealth Tool

With a Genetic Counselor

ARM D

Using the Web-Based eHealth Tool

Using the Web-Based eHealth Tool

 

The Pre-Test Genetic Session will include information on the following:

  • Reasons and Benefits for genetic testing in patients with metastatic breast, ovarian, prostate and/or pancreatic cancer
  • What types of clinical genetic testing that are offered as part of this study
  • Risks, Benefits and Limitations of genetic testing

If you are randomized to Arms A or B, you will be asked to schedule a virtual or in-person appointment to speak with a Genetic Counselor for your pre-test genetic counseling session. If you are randomized to Arms C or D, you will be provided instructions for obtaining a private code to access the Web-Based eHealth Tool. Even if you are assigned to the web-based tool, you can still request to speak with a genetic counselor if you wish.

If you choose to have genetic testing, regardless of your assigned Arm, you will receive Result Disclosure once your genetic test results become available. Information provided during the Result Disclosure will include:

  • Clinical genetic test results
  • Implication(s) of results for your treatment
  • Implication(s) of results for your relatives such as screening and prevention recommendations, lifestyle changes and potential testing recommendations

If you are randomized to Arms A or C, you will be asked to schedule a virtual or in-person appointment to speak with a Genetic Counselor for your Result Disclosure Session. Those randomized to Arms B and D will be provided instructions for obtaining a private code to access the Web-Based eHealth Tool, but can still ask to speak with a genetic counselor.

What The Study Entails 

After providing consent, you will be asked to provide detailed information on your family history of cancer and possibly other diseases. Once completed, participants will be assigned to one of four different ways to get genetic counseling and testing. Some patients will speak to a genetic counselor to learn about testing options and receive their results. These sessions are mostly completed virtually, in the comfort of participants’ homes. Others will be given the opportunity to review this same information by web. All patients will be able to speak to a genetic counselor, at any point, at no charge.  If testing is desired, a genetic counselor will coordinate. The cost of testing is often completely covered by insurance for individuals who meet testing guidelines. You will be asked to complete Surveys at the time of consent, immediately after your Pre-Test Genetic Session, immediately after your Result Disclosure Genetic Session and at 6 months after your Result Disclosure Genetic Session.

Where to Participate 

Patients throughout the country can participate in the eReach study. All study interventions, including genetic counseling, are provided by staff at the University of Pennsylvania.

Principal Investigator

Angela Bradbury, MD
Perelman School of Medicine at the University of Pennsylvania

This Study is Open To:

Men or women can participate if they:

  • have a personal history of the following:
    • metastatic breast cancer
    • advanced ovarian cancer
    • advanced pancreatic cancer
    • metastatic prostate cancer
  • are 18 years of age or older
  • can speak and understand English
This Study is Not Open To:

People cannot not participate if they:

  • have communication difficulties.
  • have not been diagnosed with advanced cancer.
  • have had previous genetic testing for an inherited mutation.