The Genetic Information and Family Testing (GIFT) study: trial design and protocol

Area of Science:

• Genetics
• Public Health
• Implementation Science

Background:

• There is a critical need for effective strategies to support engagement between patients with inherited cancer susceptibility and their at-risk relatives.
• Community-based identification and engagement of these patients can significantly reduce the gap in genetic risk evaluation for families.
• The Genetic Information and Family Testing (GIFT) Study aims to address this by engaging patients and supporting their relatives in genetic risk evaluation.

Purpose of the Study:

• To implement and evaluate a direct-to-family, virtual, personalized, family-centered communication and decision-making tool, the Family Genetic Health Program.
• To assess the impact of different levels of personalized family genetic risk navigation support (technology-assisted vs. technology plus human navigator).
• To evaluate the effect of the genetic test cost ($50 vs. free) on participation and outcomes.

Main Methods:

• A population-based, 2x2 factorial cluster-randomized clinical trial.
• Utilizes a SEER-based data infrastructure to identify eligible cancer patients with pathogenic variants in cancer susceptibility genes in Georgia and California.
• Index subjects and their invited relatives are randomized to different intervention arms, receiving varying levels of support and genetic testing options.

Main Results:

• The GIFT study provides a model for delivering virtual cascade genetic risk programs within the community.
• Findings will inform the development of next-generation implementation science for hereditary cancer syndromes.
• The study's results are relevant to stakeholders interested in population-based approaches to cascade genetic risk evaluation.

Conclusions:

• The GIFT study demonstrates a feasible blueprint for a virtual cascade genetic risk program.
• This approach effectively engages patients and their relatives in hereditary cancer syndrome management.
• The study's findings will guide future efforts in implementing and scaling genetic risk evaluation programs.