eHealth Delivery Alternative for Cancer Genetic Testing for Hereditary Cancer (eReach2)

Abramson Cancer Center at Penn Medicine

Status: Enrolling

Conditions: Cancer

Treatments: Other: Standard of Care; Other: Pre-Test Intervention; Other: Post-Test Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05427240

13021

850242 (Other Identifier)

Details and patient eligibility

About

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.

Full description

Germline cancer genetic testing has become a standard evidence-based practice, with established risk reduction and cancer screening guidelines for genetic carriers. Access to genetic specialists is limited in many areas in the US, and the traditional medical delivery model of pre- and post-test counseling with a genetic professional will not support the rising indications for genetic testing. Recent data from the National Health Interview Survey found that <20% of eligible patients with a personal or family history of breast or ovarian cancer underwent genetic testing. Thus, there is an urgent need to consider alternative delivery models to increase access and uptake of genetic testing, while maintaining adequate patient cognitive, affective and behavioral outcomes.

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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,000 participants in 4 patient groups

ARM A

Experimental group

Description:

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.

Treatment:

Other: Standard of Care

ARM B

Experimental group

Description:

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.

Treatment:

Other: Pre-Test Intervention

Other: Standard of Care

ARM C

Experimental group

Description:

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.

Treatment:

Other: Post-Test Intervention

Other: Standard of Care

ARM D

Experimental group

Description:

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.

Treatment:

Other: Post-Test Intervention

Other: Pre-Test Intervention