Recruiting

Genetic TestingeHealth Delivery Alternative for Cancer Genetic Testing for Hereditary Cancer

Sponsor:

Abramson Cancer Center at Penn Medicine

Code:

NCT05427240

Conditions

Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Pre-Test Intervention

Standard of Care

Post-Test Intervention

Study Details

Brief summary:

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.

Conditions

Cancer

Study ID

NCT05427240

Start date

Sep 28, 2022

Status verified date

Jan, 2026

Completion date

Jul 1, 2026

Anticipated

Primary completion date

Dec 24, 2025

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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 Design

Enrollment

1000 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

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.

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.

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.

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.

Interventions

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.

Standard of Care

Standard of Care with a Genetic Counselor by Remote Services

Post-Test Intervention

Primary outcome measure

The KnowGene Scale [ Time Frame: Through study completion, an average of 1 year ]
Patient Reported Outcome Measurement Information System (PROMIS) [ Time Frame: Through study completion, an average of 1 year ]
Uptake of Genetic Services [ Time Frame: Through study completion, an average of 1 year ]

Central Contacts and Locations

Central contacts

Angela R Bradbury, MD

215 615 3341 Angela.Bradbury@pennmedicine.upenn.edu

Dominique Fetzer, BA

215 662 2753 Dominique.Fetzer@pennmedicine.upenn.edu

Locations

Abramson Cancer Center at the University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

More Information

Sponsor

Abramson Cancer Center at Penn Medicine

Last update posted

Jan 16, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Abramson Cancer Center at Penn Medicine on 2026-01-16.