Cancer
Conditions
Brief summary
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
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.
Interventions
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.
OTHERStandard of Care
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.
Sponsors
AstraZeneca
Fox Chase Cancer Center
Basser Center for BRCA
Merck Sharp & Dohme LLC
Abramson Cancer Center at Penn Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Knowledge | Baseline - Within 7 days of Visit 2 | Knowledge Scale - Score Range = 0-16 Increased change score indicates increase in knowledge (better). |
| Change in Anxiety | Baseline - Within 7 days of Visit 2 | Patient-Reported Outcomes Measurement Information Systems (PROMIS) - Score Range = 4-20 Decreased score change indicates a decrease in anxiety (better). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Uncertainty | Within 7 days of Visit 2 - 6-Month Follow-Up | Multi-dimensional Impact of Cancer Risk Assessment Questionnaire (MICRA) - Score Range = 0-85 Decrease in score change indicates a decrease in uncertainty (better). |
| Change in Health Behaviors | Within 7 days of Visit 2 - 6-Month Follow-Up | Change in treatment plan and communication of results - Yes/No |
| Change in Depression | Baseline - Within 7 days of Visit 2 | Patient-Reported Outcomes Measurement Information System (PROMIS) - Score Range = 4-20 Decreased score change indicates a decrease in depression (better). |
| Frequency of Uptake of Testing | Within 7 days of Visit 1 | Testing uptake per arm - Yes/No |
| Provider Time | Within 7 days of Standard of Care V1 | Time (minutes) provider spends per study participant |
| Change in Cancer Specific Distress | Baseline - Within 7 days of Visit 2 | Impact of Events Scale (IES) - Score Range = 0-40 Decreased score change indicates a decrease in distress (better). |
Countries
United States
Outcome results
None listed