Sukh Makhnoon , Grace Getchell , Yanete Rodriguez , Luis Pena , Jennifer Rodriguez , Tiwatope Ibidapo , Nora B. Henrikson , MinJae Lee , Shelly Wu , Sara Pirzadeh-Miller
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引用次数: 0
Abstract
Background
Although cascade testing affords disease-free relatives the opportunity for genetically targeted primary disease prevention and is endorsed by multiple guidelines, utilization studies reveal that rates remain low. Lack of family communication and high testing costs are two of the most commonly documented barriers to testing. We leverage two well-known choice-architecture tools from psychology and behavioral science – default effect and zero price effect – to address these barriers and improve cascade testing rates in hereditary cancer. By altering the underlying choice architecture, individual decision-making can be influenced with minimal effort to support behavioral changes.
Methods/Design
This two-arm, single site, hybrid type I effectiveness-implementation randomized trial compares the effectiveness of a choice-architecture based cascade testing intervention versus usual care control among English-speaking patients with a pathogenic variant in a cancer susceptibility gene receiving care at a tertiary cancer center. The intervention includes proband-mediated recruitment of at-risk relatives, provision of genetic counseling, educational information about cascade genetic testing and free testing window, and return of results. The usual care arm follows standard of care for cascade genetic testing. The primary study outcome is cascade genetic testing rate measured by proband self-report. The study evaluates implementation process via survey, administrative, and interview data including acceptability, feasibility, and process outcomes.
Discussion
This trial will generate findings about the effectiveness of a cascade testing intervention targeting patients with a pathogenic variant in a cancer susceptibility gene and identify barriers and facilitators that influence implementing this intervention in clinical cancer genetic settings (ClinicalTrials.gov Identifier: NCT06284330).
期刊介绍:
Contemporary Clinical Trials is an international peer reviewed journal that publishes manuscripts pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from disciplines including medicine, biostatistics, epidemiology, computer science, management science, behavioural science, pharmaceutical science, and bioethics. Full-length papers and short communications not exceeding 1,500 words, as well as systemic reviews of clinical trials and methodologies will be published. Perspectives/commentaries on current issues and the impact of clinical trials on the practice of medicine and health policy are also welcome.