UPCC 13021 A Randomized Hybrid Type I Effectiveness-Implementation Study of an eHealth Delivery Alternative for Cancer Genetic Testing for Hereditary Cancer (eReach2) (eReach2)

Investigating Web-Based Health Delivery Alternatives for Cancer Genetic Testing

Enrolling By Invitation
18 years or above
All
Phase N/A
1000 participants needed
1 Location

Brief description of study

This randomized non-inferiority study will use a 2x2 design where traditional standard-of-care pre-test (visit 1) and post-test (visit 2: disclosure) counseling delivered by a genetic counselor are replaced with a self-directed web-based eHealth intervention to provide critical data to inform optimal ways to deliver clinical genetic testing in eligible individuals, while maintaining quality of care and favorable cognitive, affective and behavioral outcomes.

Detailed description of study

Germline cancer genetic testing has become a standard evidence-based practice, with established risk reduction and cancer screening guidelines for genetic carriers. Access to genetic specialists is limited in many areas in the US, and the traditional medical delivery model of pre- and post-test counseling with a genetic professional will not support the rising indications for genetic testing. Recent data from the National Health Interview Survey found that <20% of eligible patients with a personal or family history of breast or ovarian cancer underwent genetic testing. Thus, there is an urgent need to consider alternative delivery models to increase access and uptake of genetic testing, while maintaining adequate patient cognitive, affective and behavioral outcomes.

This study aims to evaluate the effectiveness of offering web-based eHealth delivery alternatives of pre/post-test genetic counseling to provide equal or improved timely uptake of genetic services and testing, and short-term cognitive (e.g. understanding), affective (e.g. distress and uncertainty) and behavioral (risk reducing and screening behaviors and communication to providers and relatives) outcomes in patients with barriers to genetic testing as compared to the traditional two-visit delivery model with a genetic counselor.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Cancer
  • Age: 18 years or above
  • Gender: All

Inclusion Criteria:

  • 18 years of age or older
  • Speak and understand English
  • Male or Female
  • No prior germline genetic testing
  • Meet current National Comprehensive Cancer Network (NCCN) guidelines for germline genetic testing

Exclusion Criteria:

-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

This study investigates the use of a web-based eHealth intervention as an alternative to traditional in-person genetic counseling for cancer genetic testing. The purpose of this study is to explore how this approach can provide necessary genetic testing information while maintaining the quality of care. The study aims to address the limited access to genetic specialists and increase the uptake of genetic testing among eligible individuals.

Participants in the study will either receive traditional counseling from a genetic counselor in two visits, or they will use a self-directed web-based eHealth tool. The study will measure outcomes related to understanding of genetic information, emotional responses like distress, and behaviors such as following risk reduction guidelines. The goal is to see if the eHealth approach can match or improve upon the results of traditional counseling.

  • Who can participate: Individuals who are 18 years or older, can speak and understand English, and have not undergone prior germline genetic testing may participate. They must meet the National Comprehensive Cancer Network guidelines for genetic testing. Participants should not have uncorrected hearing, vision, or speech impairments.
  • Study details: Participants will either engage in traditional in-person counseling or use a web-based health tool to receive genetic testing information. The study will focus on understanding and emotional responses related to the genetic testing process.
  • Study visits: The study requires 2 visits.
Updated on 16 Jan 2026. Study ID: 21-1375
If you need assistance finding a non-cancer clinical research study or if you have any questions, please email psom-ocr@pobox.upenn.edu For Cancer trials contact Penn Medicine's Cancer Trial Navigator at: PMCancerResearch@pennmedicine.upenn.edu or 215-349-8245

Study is selecting its participants from a population, or group of people, decided on by the researchers in advance.

Contact Abramson Cancer Center Navigator