eHealth Delivery Alternative for Cancer Genetic Testing for Hereditary Cancer

Not Applicable

Recruiting

• Conditions: Cancer
• Interventions: Other: Pre-Test Intervention; Other: Standard of Care; Other: Post-Test Intervention

• Registration Number: NCT05427240
• Lead Sponsor: Abramson Cancer Center at Penn Medicine

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2022-06-07
• Study First Submitted QC: 2022-06-16
• Study First Posted: 2022-06-22
• Study Start: 2022-09-28
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-09
• Last Update Posted: 2024-12-10
• Primary Completion: 2025-07
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ARM B	Pre-Test Intervention	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.
ARM A	Standard of Care	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.
ARM B	Standard of Care	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.
ARM C	Post-Test Intervention	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.
ARM D	Pre-Test Intervention	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.
ARM D	Post-Test Intervention	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.
ARM C	Standard of Care	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.

Primary Outcome Measures

Name	Time	Method
Patient Reported Outcome Measurement Information System (PROMIS)	Through study completion, an average of 1 year	Change in General Anxiety - Score Range = 4-20, Lower score = Better outcome
The KnowGene Scale	Through study completion, an average of 1 year	Change in Knowledge - Score Range = 0-16, Higher score = Better outcome
Uptake of Genetic Services	Through study completion, an average of 1 year	Testing uptake per arm - Yes/No

Secondary Outcome Measures

Name	Time	Method
Provider Time	Through study completion, an average of 1 year	Time (minutes) provider spends per patient
Satisfaction with genetic services	Through study completion, an average of 1 year	Differences in satisfaction by Arm - Score Range = 14-70, Higher score = Better outcome
Decisional Regret Scale	Through study completion, an average of 1 year	Differences in decisional regret by Arm - Score Range = 5-25, Lower score = Better outcome
Patient Reported Outcome Measurement Information System (PROMIS)	Through study completion, an average of 1 year	Change in General Depression - Score Range = 4-20, Lower score = Better outcome
Multi-dimensional Impact of Cancer Risk Assessment Questionnaire (MICRA)	Through study completion, an average of 1 year	Change in Uncertainty - Score Range = 0-85, Lower score = Better outcome
Impact of Events Scale (IES)	Through study completion, an average of 1 year	Change in Cancer Specific Distress - Score Range = 0-40, Lower score = Better outcome

Trial Locations

Locations (1)

Abramson Cancer Center at the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States