Cancer
Conditions
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.
Interventions
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.
OTHERStandard of Care
Standard of Care with a Genetic Counselor by Remote Services
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.
Sponsors
Abramson Cancer Center at Penn Medicine
Fox Chase Cancer Center
National Cancer Institute (NCI)
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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The KnowGene Scale | Through study completion, an average of 1 year | Change in Knowledge - Score Range = 0-16, Higher score = Better outcome |
| Patient Reported Outcome Measurement Information System (PROMIS) | Through study completion, an average of 1 year | Change in General Anxiety - Score Range = 4-20, Lower score = Better outcome |
| Uptake of Genetic Services | Through study completion, an average of 1 year | Testing uptake per arm - Yes/No |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Reported Outcome Measurement Information System (PROMIS) | Through study completion, an average of 1 year | Change in General Depression - Score Range = 4-20, Lower score = Better outcome |
| Impact of Events Scale (IES) | Through study completion, an average of 1 year | Change in Cancer Specific Distress - Score Range = 0-40, Lower score = Better outcome |
| Multi-dimensional Impact of Cancer Risk Assessment Questionnaire (MICRA) | Through study completion, an average of 1 year | Change in Uncertainty - Score Range = 0-85, Lower score = Better outcome |
| Satisfaction with genetic services | Through study completion, an average of 1 year | Differences in satisfaction by Arm - Score Range = 14-70, Higher score = Better outcome |
| Decisional Regret Scale | Through study completion, an average of 1 year | Differences in decisional regret by Arm - Score Range = 5-25, Lower score = Better outcome |
| Provider Time | Through study completion, an average of 1 year | Time (minutes) provider spends per patient |
Countries
United States
Contacts
CONTACTAngela R Bradbury, MD
CONTACTDominique Fetzer, BA
PRINCIPAL_INVESTIGATORAngela R Bradbury, MD
University of Pennsylvania
Outcome results
None listed