RecruitingInterventional

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

NCT ID: NCT05427240Sponsor: Abramson Cancer Center at Penn MedicineLast updated: 2026-01-16

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.

Arms & interventions

OtherPre-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.
OtherStandard of Care
Standard of Care with a Genetic Counselor by Remote Services
OtherPost-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.

Outcome measures

Primary

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

Secondary

Patient Reported Outcome Measurement Information System (PROMIS)
Time frame: Through study completion, an average of 1 year
Impact of Events Scale (IES)
Time frame: Through study completion, an average of 1 year
Multi-dimensional Impact of Cancer Risk Assessment Questionnaire (MICRA)
Time frame: Through study completion, an average of 1 year
Satisfaction with genetic services
Time frame: Through study completion, an average of 1 year
Decisional Regret Scale
Time frame: Through study completion, an average of 1 year
Provider Time
Time frame: Through study completion, an average of 1 year

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: Yes

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 locations (1)

Abramson Cancer Center at the University of Pennsylvania

Philadelphia, Pennsylvania, 19104

Recruiting

Angela Bradbury, MD · Contact

References

Mastaglio E, Egleston B, Lee KT, Fetzer D, Brown S, Domchek SM, Fleisher L, Wen KY, Wagner L, Roberts JS, Cacioppo C, Christiansen J, Howe S, Wood EM, Weinberg M, Karpink K, Selmani E, Feng J, John S, Schweickert K, McLeod B, Bradbury AR. A Randomized Hybrid Type I Effectiveness-Implementation Study of an eHealth Delivery Alternative for Cancer Genetic Testing for Hereditary Cancer (eREACH2): study protocol. medRxiv [Preprint]. 2025 Nov 22:2025.11.19.25340515. doi: 10.1101/2025.11.19.25340515.(PubMed)