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

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Study Overview

This study aims to determine if web-based eHealth delivery of pre-test and/or post-test counseling in cancer patients and/or those at risk for cancer, can provide equal or improved cognitive and effective outcomes when compared to the standard of care delivery model.

eReach is a randomized study. Participants will have a 25% chance of being placed in any of the following four groups. 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.

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
When randomized to Arms A or B, participants will be asked to schedule a virtual or in-person appointment to speak with a Genetic Counselor for pre-test genetic counseling session. If randomized to Arms C or D, participants will be provided instructions for obtaining a private code to access the Web-Based eHealth Tool. Even when assigned to the web-based tool, study participants can still request to speak with a genetic counselor.
 
When participants choose to have genetic testing, regardless of assigned Arm, they will receive Result Disclosure once 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 randomized to Arms A or C, participants 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.

Study Description

After providing consent, participants will be asked to provide detailed information on their 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. Participants 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.
 

Additional Information:

Exclusion criteria for this study include:
 Communication difficulties such as:
    • Uncorrected or uncompensated hearing and/or vision impairment
    • Uncorrected or uncompensated speech defects
    • Uncontrolled psychiatric/mental condition or severe physical, neurological or cognitive deficits rendering individual unable to understand study goals and tasks
    • Previous cancer germline genetic testing

  • Study Identifier: 833370

Recruitment Status

Open

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