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Principal Investigator: Angela R. Bradbury
Organization: UNIVERSITY OF PENNSYLVANIA
Fiscal Year: 2024
Award: $731,103
Funding agency: National Cancer Institute
Germline cancer genetic testing has become a standard evidence-based practice, with established risk reduction
and cancer screening guidelines for genetic carriers. Yet, access to genetic specialists is limited in many areas
in the US, and <20% of eligible patients with a personal or family history of breast or ovarian cancer complete
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. Our
research has shown that providing remote services increases uptake of genetic testing in community practices
increases uptake of genetic testing. Preliminary data from our ongoing NIH-funded RESPECT study has
revealed high interest in a web-based eHealth alternative to traditional pre-test counseling and no significant no
differences in pre- and post-disclosure outcomes when the web-based eHealth intervention is utilized as
compared to participants who received traditional pre-test genetic counselor. To address the clinically significant
need for alternative delivery models to increase access and uptake of cancer genetic testing, while maintaining
adequate patient cognitive, affective and behavioral outcomes, we propose to recruit a nationally diverse “real-
world” sample of 1000 patients who have access barriers to genetic testing and to conduct a Hybrid Type 1
effectiveness-implementation study to evaluate web-based eHealth delivery alternatives for genetic education
and testing. We hypothesize that our theoretically and stakeholder informed eHealth delivery alternatives can
provide equal or better uptake of testing and outcomes of genetic testing as compared to the traditional model
of pre- and post-test counseling with a genetic counselor. We will partner with several cancer advocacy groups
(ASCO, breastcancer.org, Cancer Support Community, Pennsylvania Prostate Cancer Coalition) to recruit
patients to this randomized non-inferiority study using a modified 2x2 design (Aims 1-2). In Arm 1, traditional
pre-test (visit 1) and post-test (visit 2: disclosure) counseling will be provided remotely through the national Penn
Telegenetics Program and compared to delivery arms where patients can complete pre-test and/or disclosure of
results through a self-directed web-based eHealth intervention, either in place of, or as an adjunct to traditional
genetic counseling. Concurrently, we will conduct a CFIR (Consolidated Framework for Implementation
Research)-informed process evaluation to understand moderators of intervention usage and patient outcomes
and facilitators and barriers to future implementation and sustainability of this novel eHealth alternative delivery
model for genetic services both within and beyond cancer care (Aim 3). We hypothesize that a rigorously
developed theoretically and stake-holder informed eHealth delivery alternative provided through a centralized
Telegenetics Program has the potential to provide equal or improved patient outcomes, while reducing genetic
provider time and providing access to services in community practices where access to genetic services has
been limited, providing opportunities to realize the promise of precision medicine in oncology.
Terms: <ASCO><Access to Care><Address><Affective><American Society of Clinical Oncology><Area><Behavior><Behavioral><Breast Cancer><Cancer Advocacy><Cancers><Clinical><Clinical genetics><Cognitive><Collaborations><Communication><Communities><Community Practice><Consolidated Framework for Implementation Research><Consolidated Framework for Implementation Science><Consolidated Framework for Implementing Change><Counseling><Data><Disclosure><Distress><Education><Educational aspects><Effectiveness><Eligibility><Eligibility Determination><Evidence based practice><Familiar Malignant Neoplasm><Family Medical History><Family Medical History Epidemiology><Family history of><Funding><Future><Genetic><Genetic Carriers><Genetic Counseling><Genetic Models><Genetic Services><Germ Lines><Health Services Accessibility><Hereditary Cancer><Hereditary Malignant Neoplasm><Hybrids><Information Disclosure><Intervention><Intervention Strategies><Malignant Breast Neoplasm><Malignant Neoplasms><Malignant Ovarian Neoplasm><Malignant Ovarian Tumor><Malignant Tumor><Malignant Tumor of the Ovary><Malignant Tumor of the Prostate><Malignant neoplasm of ovary><Malignant neoplasm of prostate><Malignant prostatic tumor><Medical><Medical Genetics><Methods><Modeling><NIH><National Health Interview Survey><National Institutes of Health><On-Line Systems><Oncology><Oncology Cancer><Online Systems><Outcome><Ovary Cancer><Participant><Patient Recruitments><Patient outcome><Patient-Centered Outcomes><Patient-Focused Outcomes><Patients><Pennsylvania><Phone><Predisposition><Prostate CA><Prostate Cancer><Prostate malignancy><Prostatic Cancer><Protocol Screening><Provider><Randomized><Reaction><Recommendation><Reporting><Research><Risk><Risk Reduction><Sampling><Screening for cancer><Secure><Self Direction><Services><Specialist><Susceptibility><Telephone><Test Result><Testing><Time><Uncertainty><United States National Institutes of Health><Visit><access to health services><access to services><access to treatment><accessibility to health services><allele carriers><arm><assess effectiveness><availability of services><barriers to implementation><behavior outcome><behavioral outcome><cancer care><cancer genetics><cancer predisposition><care access><care as usual><clinical practice><clinical significance><clinically significant><clinician communication><communicate to clinicians><communicate to providers><communicate with clinicians><communicate with doctors><communicate with providers><design><designing><determine effectiveness><doctor communication><doubt><e-Health><eHealth><early cancer detection><effectiveness assessment><effectiveness evaluation><effectiveness/implementation hybrid study><effectiveness/implementation study><electronic health><evaluate effectiveness><examine effectiveness><familial cancer><future implementation><gene testing><gene-based testing><genetic counselor><genetic testing><health service access><health services availability><implementation barriers><implementation challenges><improved><interest><interventional strategy><malignancy><malignant breast tumor><neoplasm/cancer><novel><online computer><ovarian cancer><participant recruitment><patient oriented outcomes><patient population><precision medicine><precision-based medicine><process evaluation><programs><provider communication><randomisation><randomization><randomly assigned><recommended screening><recruit><reduce risk><reduce risks><reduce that risk><reduce the risk><reduce these risks><reduces risk><reduces the risk><reducing risk><reducing the risk><risk-reducing><screening><screening cancer patients><screening guidelines><screening recommendations><screenings><service availability><socio-demographic factors><sociodemographic factors><telegenetics><testing uptake><treatment access><treatment as usual><uptake><usual care><videoconference><videoconferences><web based>