eHealth Delivery Alternative for Cancer Genetic Testing for Hereditary Cancer (eReach2)

A Randomized Hybrid Type I Effectiveness-Implementation Study of an eHealth Delivery Alternative for Cancer Genetic Testing for Hereditary Cancer

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.

Study Overview

• Status: Recruiting
• Conditions: Cancer
• Intervention / Treatment: Other: Standard of Care; Other: Pre-Test Intervention; Other: Post-Test Intervention

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 1000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Angela R Bradbury, MD; Phone Number: 215 615 3341; Email: Angela.Bradbury@pennmedicine.upenn.edu
• Study Contact Backup: Name: Dominique Fetzer, BA; Phone Number: 215 662 2753; Email: Dominique.Fetzer@pennmedicine.upenn.edu

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • Abramson Cancer Center at the University of Pennsylvania
      • Contact: Angela Bradbury, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ARM D; Visit 1/Pre-Test Session - Self-directed web-based eHealth pre-test session intervention. Visit 2/Disclosure Session - Self-directed web-based eHealth result disclosure intervention.	Other: Pre-Test Intervention; Secure and accessible by private code only, the web-based intervention will provide users with a the results of their clinical genetic testing results and a detailed summary of what those results mean. Additionally, an individualized summary will also be included.; Other: Post-Test Intervention; Secure and accessible by private code only, the web-based intervention will provide users with a the results of their clinical genetic testing results and a detailed summary of what those results mean. Additionally, an individualized summary will also be included.
Experimental: ARM A; Visit 1/Pre-Test Session - Standard-of-Care Pre-Test Counseling with a genetic counselor. Visit 2/Disclosure Session - Standard-of-Care Post-Test Counseling with a genetic counselor.	Other: Standard of Care; Standard of Care with a Genetic Counselor by Remote Services
Experimental: ARM B; Visit 1/Pre-Test Session - Standard-of-Care Pre-Test Counseling with a genetic counselor. Visit 2/Disclosure Session - Self-directed web-based eHealth result disclosure intervention.	Other: Standard of Care; Standard of Care with a Genetic Counselor by Remote Services; Other: Pre-Test Intervention; Secure and accessible by private code only, the web-based intervention will provide users with a the results of their clinical genetic testing results and a detailed summary of what those results mean. Additionally, an individualized summary will also be included.
Experimental: ARM C; Visit 1/Pre-Test Session - Self-directed web-based eHealth pre-test session intervention. Visit 2/Disclosure Session - Standard-of-Care Post-Test Counseling with a genetic counselor.	Other: Standard of Care; Standard of Care with a Genetic Counselor by Remote Services; Other: Post-Test Intervention; Secure and accessible by private code only, the web-based intervention will provide users with a the results of their clinical genetic testing results and a detailed summary of what those results mean. Additionally, an individualized summary will also be included.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The KnowGene Scale	Change in Knowledge - Score Range = 0-16, Higher score = Better outcome	Through study completion, an average of 1 year
Patient Reported Outcome Measurement Information System (PROMIS)	Change in General Anxiety - Score Range = 4-20, Lower score = Better outcome	Through study completion, an average of 1 year
Uptake of Genetic Services	Testing uptake per arm - Yes/No	Through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Reported Outcome Measurement Information System (PROMIS)	Change in General Depression - Score Range = 4-20, Lower score = Better outcome	Through study completion, an average of 1 year
Impact of Events Scale (IES)	Change in Cancer Specific Distress - Score Range = 0-40, Lower score = Better outcome	Through study completion, an average of 1 year
Multi-dimensional Impact of Cancer Risk Assessment Questionnaire (MICRA)	Change in Uncertainty - Score Range = 0-85, Lower score = Better outcome	Through study completion, an average of 1 year
Satisfaction with genetic services	Differences in satisfaction by Arm - Score Range = 14-70, Higher score = Better outcome	Through study completion, an average of 1 year
Decisional Regret Scale	Differences in decisional regret by Arm - Score Range = 5-25, Lower score = Better outcome	Through study completion, an average of 1 year
Provider Time	Time (minutes) provider spends per patient	Through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Abramson Cancer Center at Penn Medicine
• Collaborators: National Cancer Institute (NCI); Fox Chase Cancer Center
• Investigators: Principal Investigator: Angela R Bradbury, MD, University of Pennsylvania

Publications and helpful links

General Publications

• Mastaglio E, Egleston B, Lee KT, Fetzer D, Brown S, Domchek SM, Fleisher L, Wen KY, Wagner L, Roberts JS, Cacioppo C, Christiansen J, Howe S, Wood EM, Weinberg M, Karpink K, Selmani E, Feng J, John S, Schweickert K, McLeod B, Bradbury AR. A Randomized Hybrid Type I Effectiveness-Implementation Study of an eHealth Delivery Alternative for Cancer Genetic Testing for Hereditary Cancer (eREACH2): study protocol. medRxiv [Preprint]. 2025 Nov 22:2025.11.19.25340515. doi: 10.1101/2025.11.19.25340515.

Study record dates

Study Major Dates

• Study Start (Actual): September 28, 2022
• Primary Completion (Actual): December 24, 2025
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: June 7, 2022
• First Submitted That Met QC Criteria: June 16, 2022
• First Posted (Actual): June 22, 2022

Study Record Updates

• Last Update Posted (Estimated): January 16, 2026
• Last Update Submitted That Met QC Criteria: January 15, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care
• Other Study ID Numbers: 13021; 850242 (Other Identifier: University of Pennsylvania IRB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No