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| ID | Type | Description | Link |
|---|---|---|---|
| 850242 | Other Identifier | University of Pennsylvania IRB |
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| Name | Class |
|---|---|
| Fox Chase Cancer Center | OTHER |
| National Cancer Institute (NCI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ARM A | Experimental | 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. |
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| ARM B | Experimental | 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. |
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| ARM C | Experimental | 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. |
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| ARM D | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pre-Test Intervention | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The KnowGene Scale | Change in Knowledge - Score Range = 0-16, Higher score = Better outcome | 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 | Through study completion, an average of 1 year |
| Uptake of Genetic Services | Testing uptake per arm - Yes/No | Through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Reported Outcome Measurement Information System (PROMIS) | Change in General Depression - Score Range = 4-20, Lower score = Better outcome | Through study completion, an average of 1 year |
| Impact of Events Scale (IES) |
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Inclusion Criteria:
Exclusion Criteria:
-Communication difficulties such as:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Angela R Bradbury, MD | Contact | 215 615 3341 | Angela.Bradbury@pennmedicine.upenn.edu | |
| Dominique Fetzer, BA | Contact | 215 662 2753 | Dominique.Fetzer@pennmedicine.upenn.edu |
| Name | Affiliation | Role |
|---|---|---|
| Angela R Bradbury, MD | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Abramson Cancer Center at the University of Pennsylvania | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41332807 | Derived | Mastaglio E, Egleston B, Lee KT, Fetzer D, Brown S, Domchek SM, Fleisher L, Wen KY, Wagner L, Roberts JS, Cacioppo C, Christiansen J, Howe S, Wood EM, Weinberg M, Karpink K, Selmani E, Feng J, John S, Schweickert K, McLeod B, Bradbury AR. A Randomized Hybrid Type I Effectiveness-Implementation Study of an eHealth Delivery Alternative for Cancer Genetic Testing for Hereditary Cancer (eREACH2): study protocol. medRxiv [Preprint]. 2025 Nov 22:2025.11.19.25340515. doi: 10.1101/2025.11.19.25340515. |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Standard of Care | Other | Standard of Care with a Genetic Counselor by Remote Services |
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| Post-Test Intervention | Other | 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. |
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Change in Cancer Specific Distress - Score Range = 0-40, Lower score = Better outcome
| 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 | 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 | 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 | Through study completion, an average of 1 year |
| Provider Time | Time (minutes) provider spends per patient | Through study completion, an average of 1 year |