eHealth Delivery Alternative for Cancer Genetic Testing for Hereditary Cancer

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Abramson Cancer Center at Penn Medicine
Study ID
NCT05427240
Status
Recruiting
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Conditions

  • Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Pre-Test Intervention — OTHER
    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 — OTHER
    Standard of Care with a Genetic Counselor by Remote Services
  • Post-Test Intervention — OTHER
    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.

Study Details

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.

Key Dates

Start date
Sep 28, 2022
Status verified
Jan 2026
Primary completion
Dec 24, 2025
Completion
Jul 1, 2026

Study Design

Enrollment
1,000 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

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.

Primary Outcome Measure

The KnowGene Scale [ Time Frame: Through study completion, an average of 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Abramson Cancer Center at the University of PennsylvaniaPhiladelphiaPennsylvania19104
Angela Bradbury, MD

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By research site
Abramson Cancer Center at the University of Pennsylvania· Philadelphia, PA

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