An interventional study of Pre-Test Intervention and Standard of Care in Cancer, sponsored by Abramson Cancer Center at Penn Medicine. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-16.
Sponsored by Abramson Cancer Center at Penn Medicine · Not applicable, Interventional, and Other
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.
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.
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 50 across 7,253 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →Abramson Cancer Center at Penn Medicine is the lead sponsor of 446 studies on the registry; 86 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 14 (44%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
-Communication difficulties such as:
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
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 · Other: Standard of Care
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 · Other: Post-Test Intervention
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 · Other: Post-Test Intervention
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.
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.
The KnowGene Scale
Change in Knowledge - Score Range = 0-16, Higher score = Better outcome
Time frame: 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
Time frame: Through study completion, an average of 1 year
Uptake of Genetic Services
Testing uptake per arm - Yes/No
Time frame: Through study completion, an average of 1 year
Patient Reported Outcome Measurement Information System (PROMIS)
Change in General Depression - Score Range = 4-20, Lower score = Better outcome
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Through study completion, an average of 1 year
Provider Time
Time (minutes) provider spends per patient
Time frame: Through study completion, an average of 1 year
Plan to share: No
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Abramson Cancer Center at Penn Medicine