Clinical trial NCT05427240: eHealth Delivery Alternative for Cancer Genetic Testing for Hereditary Cancer
Official title: A Randomized Hybrid Type I Effectiveness-Implementation Study of an eHealth Delivery Alternative for Cancer Genetic Testing for Hereditary Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
Collaborators: name: Fox Chase Cancer Center
name: National Cancer Institute (NCI)
First posted: 2022-06-22
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: The KnowGene Scale
timeFrame: Through study completion, an average of 1 year
measure: Patient Reported Outcome Measurement Information System (PROMIS)
timeFrame: Through study completion, an average of 1 year
measure: Uptake of Genetic Services
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Patient Reported Outcome Measurement Information System (PROMIS)
timeFrame: Through study completion, an average of 1 year
measure: Impact of Events Scale (IES)
timeFrame: Through study completion, an average of 1 year
measure: Multi-dimensional Impact of Cancer Risk Assessment Questionnaire (MICRA)
timeFrame: Through study completion, an average of 1 year
measure: Satisfaction with genetic services
timeFrame: Through study completion, an average of 1 year
measure: Decisional Regret Scale
timeFrame: Through study completion, an average of 1 year
measure: Provider Time
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Abramson Cancer Center at the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Angela R Bradbury, MD
role: PRINCIPAL_INVESTIGATOR
References: