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
Study Contact Information:
If you have questions you can contact the study team at:
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 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 study. To be 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 breast, ovarian, 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 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 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 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 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
Men or women can participate if they:
- have a personal history of the following:
- breast cancer
- advanced ovarian cancer
- advanced pancreatic cancer
- prostate cancer
- are 18 years of age or older
- can speak and understand English
People cannot not participate if they:
- have communication difficulties.
- have not been diagnosed with advanced cancer.
- have had previous genetic testing for an .