Study of an eHealth Delivery Alternative for Cancer Genetic Testing for Hereditary Predisposition in Metastatic Cancer Patients (eReach)

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

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 affective outcomes when compared to the standard of care delivery model.

Study Overview

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

Detailed Description

Cancer genetic testing has become a standard evidence-based practice, with established risk reduction and cancer screening guidelines for genetic carriers. With FDA approval for PARP inhibitors in patients with advanced breast, ovarian, pancreatic and prostate cancer, there is an additional therapeutic rationale for testing all breast, ovarian, pancreatic and prostate cancer patients for germline genetic mutations. Yet, access to genetic specialists is limited in many area, and the traditional model of pre- and post-test counseling with a genetic professional will not support the rising indications for cancer genetic testing. Thus, there is an urgent need to consider alternative delivery models to increase access and uptake of testing, while maintaining adequate patient outcomes.

This study aims to assess if traditional pre-test (visit 1) and post-test (visit 2: disclosure) counseling delivered by a genetic counselor can be replaced with a self-directed web-based eHealth intervention to provide critical data to inform optimal ways to deliver cancer genetic testing in patients with breast, ovarian, pancreatic and prostate cancer, while maintaining quality of care and favorable cognitive, affective and behavioral outcomes.

Specific Aim 1: To determine if web-based eHealth delivery of pre-test and/or post-test counseling can provide equal or improved cognitive and affective short-term and 6-month outcomes as compared to the two-visit standard of care delivery model with a genetic counselor. The investigator's primary outcomes will be changes in knowledge and anxiety. Secondary outcomes will include uptake of testing, depression, cancer specific distress, uncertainty and health behaviors and provider time.

• Study Type: Interventional
• Enrollment (Estimated): 560
• 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 University of Pennsylvania
      • Contact: Angela Bradbury, MD; Email: Angela.Bradbury@uphs.upenn.edu
      • Principal Investigator: 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

• A personal history of one or more of the following:

  • metastatic breast cancer
  • advanced ovarian cancer (Stage III-IV)
  • metastatic pancreatic cancer
  • metastatic prostate cancer
• Naive to previous cancer 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 A; Visit 1/Pre-Test Session - Standard-of-Care Pre-Test Counseling with a genetic counselor either in-person or by remote services (Telephone or Video Conferencing). Visit 2/Disclosure Session - Standard-of-Care Post-Test Counseling with a genetic counselor either in-person or by remote services (Telephone or Video Conferencing).	Other: Standard of Care; Standard of Care with a Genetic Counselor either In-Person or by Remote Services (Telephone or Video Conferencing)
Experimental: ARM B; Visit 1/Pre-Test Session - Standard-of-Care Pre-Test Counseling with a genetic counselor either in-person or by remote services (Telephone or Video Conferencing). Visit 2/Disclosure Session - Self-directed web-based eHealth result disclosure intervention.	Other: Standard of Care; Standard of Care with a Genetic Counselor either In-Person or by Remote Services (Telephone or Video Conferencing); Other: Post-Test Intervention; Secure and accessable 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 either in-person or by remote services (Telephone or Video Conferencing).	Other: Standard of Care; Standard of Care with a Genetic Counselor either In-Person or by Remote Services (Telephone or Video Conferencing); Other: Pre-Test Intervention; Secure and accessable 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 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: Post-Test Intervention; Secure and accessable 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: Pre-Test Intervention; Secure and accessable 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
Change in Knowledge	Knowledge Scale - Score Range = 0-16 Increased change score indicates increase in knowledge (better).	Baseline - Within 7 days of Visit 2
Change in Anxiety	Patient-Reported Outcomes Measurement Information Systems (PROMIS) - Score Range = 4-20 Decreased score change indicates a decrease in anxiety (better).	Baseline - Within 7 days of Visit 2

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Depression	Patient-Reported Outcomes Measurement Information System (PROMIS) - Score Range = 4-20 Decreased score change indicates a decrease in depression (better).	Baseline - Within 7 days of Visit 2
Change in Cancer Specific Distress	Impact of Events Scale (IES) - Score Range = 0-40 Decreased score change indicates a decrease in distress (better).	Baseline - Within 7 days of Visit 2
Change in Uncertainty	Multi-dimensional Impact of Cancer Risk Assessment Questionnaire (MICRA) - Score Range = 0-85 Decrease in score change indicates a decrease in uncertainty (better).	Within 7 days of Visit 2 - 6-Month Follow-Up
Change in Health Behaviors	Change in treatment plan and communication of results - Yes/No	Within 7 days of Visit 2 - 6-Month Follow-Up
Provider Time	Time (minutes) provider spends per study participant	Within 7 days of Standard of Care V1
Provider Time	Time (minutes) provider spends per study participant	Within 7 days of Standard of Care V2
Frequency of Uptake of Testing	Testing uptake per arm - Yes/No	Within 7 days of Visit 1

Collaborators and Investigators

• Sponsor: Abramson Cancer Center at Penn Medicine
• Collaborators: Fox Chase Cancer Center; Merck Sharp & Dohme LLC; AstraZeneca; Basser Center for BRCA

Study record dates

Study Major Dates

• Study Start (Actual): August 17, 2020
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: April 3, 2020
• First Submitted That Met QC Criteria: April 16, 2020
• First Posted (Actual): April 21, 2020

Study Record Updates

• Last Update Posted (Actual): January 16, 2024
• Last Update Submitted That Met QC Criteria: January 12, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Disease Susceptibility
• Other Study ID Numbers: UPCC 11919; IRB#833370 (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