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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
256
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.
Standard of Care with a Genetic Counselor either In-Person or by Remote Services (Telephone or Video Conferencing)
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.
Abramson Cancer Center at University of Pennsylvania
Philadelphia, Pennsylvania, United States
Change in Knowledge
Knowledge Scale - Score Range = 0-16 Increased change score indicates increase in knowledge (better).
Time frame: 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).
Time frame: Baseline - Within 7 days of Visit 2
Change in Depression
Patient-Reported Outcomes Measurement Information System (PROMIS) - Score Range = 4-20 Decreased score change indicates a decrease in depression (better).
Time frame: 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).
Time frame: 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).
Time frame: Within 7 days of Visit 2 - 6-Month Follow-Up
Change in Health Behaviors
Change in treatment plan and communication of results - Yes/No
Time frame: Within 7 days of Visit 2 - 6-Month Follow-Up
Provider Time
Time (minutes) provider spends per study participant
Time frame: Within 7 days of Standard of Care V1
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Provider Time
Time (minutes) provider spends per study participant
Time frame: Within 7 days of Standard of Care V2
Frequency of Uptake of Testing
Testing uptake per arm - Yes/No
Time frame: Within 7 days of Visit 1