Abramson Cancer Center at the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Location status: Recruiting
Location contact
Angela Bradbury, MD
CONTACT
NCT Number: NCT05427240
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Philadelphia, Pennsylvania, 19104, United States
Location status: Recruiting
Angela Bradbury, MD
CONTACT
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
-Communication difficulties such as:
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.
Time frame: Through study completion, an average of 1 year
Change in Knowledge - Score Range = 0-16, Higher score = Better outcome
Time frame: Through study completion, an average of 1 year
Change in General Anxiety - Score Range = 4-20, Lower score = Better outcome
Time frame: Through study completion, an average of 1 year
Testing uptake per arm - Yes/No
Time frame: Through study completion, an average of 1 year
Change in General Depression - Score Range = 4-20, Lower score = Better outcome
Time frame: Through study completion, an average of 1 year
Change in Cancer Specific Distress - Score Range = 0-40, Lower score = Better outcome
Time frame: Through study completion, an average of 1 year
Change in Uncertainty - Score Range = 0-85, Lower score = Better outcome
Time frame: Through study completion, an average of 1 year
Differences in satisfaction by Arm - Score Range = 14-70, Higher score = Better outcome
Time frame: Through study completion, an average of 1 year
Differences in decisional regret by Arm - Score Range = 5-25, Lower score = Better outcome
Time frame: Through study completion, an average of 1 year
Time (minutes) provider spends per patient
Contact information is provided by the study sponsor or research team.
Angela R Bradbury, MD
CONTACT
Dominique Fetzer, BA
CONTACT
Abramson Cancer Center at Penn Medicine
Other
A Randomized Hybrid Type I Effectiveness-Implementation Study of an eHealth Delivery Alternative for Cancer Genetic Testing for Hereditary Cancer
Acronym: eReach2
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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