Study of an eHealth Delivery Alternative for Cancer Genetic Testing for Hereditary Predisposition in Metastatic Cancer Patients

Study Overview
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Brief Summary
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This study aims to determine if web-based eHealth delivery of pre-test and/or post-test counseling in cancer patients and/or those at risk for cancer can provide equal or improved cognitive and affective outcomes when compared to the standard of care delivery model.

Detailed Description
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Cancer genetic testing has become a standard evidence-based practice, with established risk reduction and cancer screening guidelines for genetic carriers. With FDA approval for PARP inhibitors in patients with advanced breast, ovarian, pancreatic and prostate cancer, there is an additional therapeutic rationale for testing all breast, ovarian, pancreatic and prostate cancer patients for germline genetic mutations. Yet, access to genetic specialists is limited in many area, and the traditional model of pre- and post-test counseling with a genetic professional will not support the rising indications for cancer genetic testing. Thus, there is an urgent need to consider alternative delivery models to increase access and uptake of testing, while maintaining adequate patient outcomes. This study aims to assess if traditional pre-test (visit 1) and post-test (visit 2: disclosure) counseling delivered by a genetic counselor can be replaced with a self-directed web-based eHealth intervention to provide critical data to inform optimal ways to deliver cancer genetic testing in patients with breast, ovarian, pancreatic and prostate cancer, while maintaining quality of care and favorable cognitive, affective and behavioral outcomes. Specific Aim 1: To determine if web-based eHealth delivery of pre-test and/or post-test counseling can provide equal or improved cognitive and affective short-term and 6-month outcomes as compared to the two-visit standard of care delivery model with a genetic counselor. The investigator's primary outcomes will be changes in knowledge and anxiety. Secondary outcomes will include uptake of testing, depression, cancer specific distress, uncertainty and health behaviors and provider time.

Official Title
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A Randomized Study of an eHealth Delivery Alternative for Cancer Genetic Testing for Hereditary Predisposition in Metastatic Breast, Ovarian, Prostate and Pancreatic Cancer Patients

Conditions
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Cancer

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years of age or older Speak and understand English Male or Female A personal history of one or more of the following: metastatic breast cancer advanced ovarian cancer (Stage III-IV) metastatic pancreatic cancer metastatic prostate cancer Naive to previous cancer 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
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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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 either in-person or by remote services (Telephone or Video Conferencing). Visit 2/Disclosure Session - Standard-of-Care Post-Test Counseling with a genetic counselor either in-person or by remote services (Telephone or Video Conferencing). | Other: Standard of Care<br>* Standard of Care with a Genetic Counselor either In-Person or by Remote Services (Telephone or Video Conferencing)<br>|
| Experimental: ARM B<br>Visit 1/Pre-Test Session - Standard-of-Care Pre-Test Counseling with a genetic counselor either in-person or by remote services (Telephone or Video Conferencing). Visit 2/Disclosure Session - Self-directed web-based eHealth result disclosure intervention. | Other: Standard of Care<br>* Standard of Care with a Genetic Counselor either In-Person or by Remote Services (Telephone or Video Conferencing)<br>Other: Post-Test Intervention<br>* Secure and accessable 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 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 either in-person or by remote services (Telephone or Video Conferencing). | Other: Pre-Test Intervention<br>* Secure and accessable 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 either In-Person or by Remote Services (Telephone or Video Conferencing)<br>|
| Experimental: ARM D<br>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. | Other: Pre-Test Intervention<br>* Secure and accessable 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 accessable 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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Knowledge | Knowledge Scale - Score Range = 0-16 Increased change score indicates increase in knowledge (better). | Baseline - Within 7 days of Visit 2 | 
| Change in Anxiety | Patient-Reported Outcomes Measurement Information Systems (PROMIS) - Score Range = 4-20 Decreased score change indicates a decrease in anxiety (better). | Baseline - Within 7 days of Visit 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Depression | Patient-Reported Outcomes Measurement Information System (PROMIS) - Score Range = 4-20 Decreased score change indicates a decrease in depression (better). | Baseline - Within 7 days of Visit 2 | 
| Change in Cancer Specific Distress | Impact of Events Scale (IES) - Score Range = 0-40 Decreased score change indicates a decrease in distress (better). | Baseline - Within 7 days of Visit 2 | 
| Change in Uncertainty | Multi-dimensional Impact of Cancer Risk Assessment Questionnaire (MICRA) - Score Range = 0-85 Decrease in score change indicates a decrease in uncertainty (better). | Within 7 days of Visit 2 - 6-Month Follow-Up | 
| Change in Health Behaviors | Change in treatment plan and communication of results - Yes/No | Within 7 days of Visit 2 - 6-Month Follow-Up | 
| Provider Time | Time (minutes) provider spends per study participant | Within 7 days of Standard of Care V1 | 
| Provider Time | Time (minutes) provider spends per study participant | Within 7 days of Standard of Care V2 | 
| Frequency of Uptake of Testing | Testing uptake per arm - Yes/No | Within 7 days of Visit 1 |