eHealth Delivery Alternative for Cancer Genetic Testing for Hereditary Cancer

Study Overview
=================
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.

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

Conditions
-----------------
Cancer

Intervention / Treatment
-----------------
* Other: Pre-Test Intervention
* Other: Standard of Care
* Other: Post-Test Intervention


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ARM A<br>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. | Other: Standard of Care<br>* Standard of Care with a Genetic Counselor by Remote Services<br>|
| Experimental: ARM B<br>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. | Other: Pre-Test Intervention<br>* 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.<br>Other: Standard of Care<br>* Standard of Care with a Genetic Counselor by Remote Services<br>|
| Experimental: ARM C<br>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. | Other: Standard of Care<br>* Standard of Care with a Genetic Counselor by Remote Services<br>Other: Post-Test Intervention<br>* 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.<br>|
| Experimental: ARM D<br>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. | Other: Pre-Test Intervention<br>* 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.<br>Other: Post-Test Intervention<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The KnowGene Scale | Change in Knowledge - Score Range = 0-16, Higher score = Better outcome | 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 | Through study completion, an average of 1 year | 
| Uptake of Genetic Services | Testing uptake per arm - Yes/No | Through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| Provider Time | Time (minutes) provider spends per patient | Through study completion, an average of 1 year |