Study Of An EHealth Delivery Alternative For Cancer Genetic Testing For Hereditary Predisposition In Metastatic Cancer Patients

Study Overview

Study of an eHealth Delivery Alternative for Cancer Genetic Testing for Hereditary Predisposition in Metastatic 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.

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.

Cancer

OTHER: Pre-Test Intervention
OTHER: Standard of Care
OTHER: Post-Test Intervention

UPCC 11919
IRB#833370 (OTHER Identifier) (OTHER: University of Pennsylvania IRB)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2020-04-03	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-04-03
First Submitted that Met QC Criteria 2020-04-16	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-04-06
First Posted (ACTUAL) 2020-04-21	Results First Posted N/A	Last Verified 2025-04

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Other

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
None

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	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
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: 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 OTHER: Standard of Care Standard of Care with a Genetic Counselor either In-Person or by Remote Services (Telephone or Video Conferencing)
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 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 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

Primary Outcome Measures	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	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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:
1

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

AstraZeneca
Fox Chase Cancer Center
Basser Center for BRCA
Merck Sharp & Dohme LLC

Investigators

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

Learn

Resources

Patients

Caregivers

Clinical Trial Record