eHealth Delivery Alternative for Cancer Genetic Testing for Hereditary Cancer

Cancer Clinical Trial

— eReach2  

Official title:

A Randomized Hybrid Type I Effectiveness-Implementation Study of an eHealth Delivery Alternative for Cancer Genetic Testing for Hereditary Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05427240
• Other study ID #: 13021
• Secondary ID: 850242
• Status: Recruiting
• Phase: N/A
• Start date: September 28, 2022
• Est. completion date: January 2026

Study information

• Verified date: October 2023
• Source: Abramson Cancer Center at Penn Medicine
• Contact: Angela R Bradbury, MD
• Phone: 215 615 3341
• Email: Angela.Bradbury[@]pennmedicine.upenn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: January 2026
• Est. primary completion date: July 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United States	Abramson Cancer Center at the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Abramson Cancer Center at Penn Medicine	Fox Chase Cancer Center, National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The KnowGene Scale	Change in Knowledge - Score Range = 0-16, Higher score = Better outcome	Through study completion, an average of 1 year
Primary	Patient Reported Outcome Measurement Information System (PROMIS)	Change in General Anxiety - Score Range = 4-20, Lower score = Better outcome	Through study completion, an average of 1 year
Primary	Uptake of Genetic Services	Testing uptake per arm - Yes/No	Through study completion, an average of 1 year
Secondary	Patient Reported Outcome Measurement Information System (PROMIS)	Change in General Depression - Score Range = 4-20, Lower score = Better outcome	Through study completion, an average of 1 year
Secondary	Impact of Events Scale (IES)	Change in Cancer Specific Distress - Score Range = 0-40, Lower score = Better outcome	Through study completion, an average of 1 year
Secondary	Multi-dimensional Impact of Cancer Risk Assessment Questionnaire (MICRA)	Change in Uncertainty - Score Range = 0-85, Lower score = Better outcome	Through study completion, an average of 1 year
Secondary	Satisfaction with genetic services	Differences in satisfaction by Arm - Score Range = 14-70, Higher score = Better outcome	Through study completion, an average of 1 year
Secondary	Decisional Regret Scale	Differences in decisional regret by Arm - Score Range = 5-25, Lower score = Better outcome	Through study completion, an average of 1 year
Secondary	Provider Time	Time (minutes) provider spends per patient	Through study completion, an average of 1 year