eHealth Delivery Alternative for Cancer Genetic Testing for Hereditary Cancer
NCT ID: NCT05427240
Last Updated: 2025-11-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
1000 participants
INTERVENTIONAL
2022-09-28
2026-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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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.
Standard of Care
Standard of Care with a Genetic Counselor by Remote Services
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.
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
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.
Standard of Care
Standard of Care with a Genetic Counselor by Remote Services
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.
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.
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.
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.
Interventions
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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
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
Yes
Sponsors
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Fox Chase Cancer Center
OTHER
National Cancer Institute (NCI)
NIH
Abramson Cancer Center at Penn Medicine
OTHER
Responsible Party
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Principal Investigators
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Angela R Bradbury, MD
Role: PRINCIPAL_INVESTIGATOR
University of Pennsylvania
Locations
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Abramson Cancer Center at the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Countries
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Central Contacts
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Facility Contacts
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Angela Bradbury, MD
Role: primary
Other Identifiers
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850242
Identifier Type: OTHER
Identifier Source: secondary_id
13021
Identifier Type: -
Identifier Source: org_study_id