R01HG011928

A Stakeholder-Informed Randomized Trial of Pretest Video Education vs Standard Genetic Counseling for Cancer Patients: Evaluating the Impact on Patients, Providers, and Practices - Project Summary/Abstract

Despite the well-established benefits of germline genetic testing (GGT) for cancer patients, including informing treatment and family members, there has been inconsistent integration of GGT into oncology workflows, leading to significant gaps in care. In less resource-rich environments, less labor-intensive and streamlined service delivery strategies may improve access to testing and reduce the burden on sick cancer patients. This proposal directly responds to RFA-HG-20-048 by measuring the efficacy and acceptability of novel genetic counseling practices aimed at modernizing genetics care.

The overall objectives of this application are to refine our pretest cancer genetics video education and result-dependent disclosure (VERDI) intervention, compare patient-centered outcomes of VERDI to standard counseling, elucidate required resources and costs, and delineate the receptivity and readiness for implementation of VERDI by genetic counselors (GCs). The rationale for the proposed research is that alternative models must be informed by rigorous evaluation of effects on patients and GCs. These goals will be accomplished by pursuing three specific aims:

(I) Refine and adapt VERDI to ensure acceptability among diverse cancer patients.
(II) Conduct a randomized trial of VERDI vs standard genetic counseling care through two cancer centers and their community partners, and compare patient-centered outcomes.
(III) Evaluate the impact of the VERDI paradigm on GCs and costs to inform practice.

In aims 1 and 2, the studies will include patients of diverse backgrounds in several settings with cancers for which GGT is standard and those for which it is less routine. Qualitative interviews of patients will inform the refinement of VERDI, followed by a randomized trial of VERDI vs standard of care genetic counseling with measurement of the following patient-centered outcomes: receipt of intervention, testing uptake, satisfaction, psychosocial impact, knowledge, and family communication.

Aim 3 will use a mixed-methods analysis through semi-structured qualitative interviews, followed by a national survey of GCs, to elucidate facilitators and barriers to widespread implementation. Under this aim, a cost analysis evaluating cost-per-patient tested will be performed using data collected during the randomized trial.

The research proposed in this application is innovative because it uses simple, adaptable technology combined with a pragmatic, patient-centered approach informed by the needs of diverse patients to standardize processes. Robust outcomes of all stakeholders, especially GCs whose role would change the most, are measured. The proposed research is significant because it is expected to provide patient, provider, and systems-level data to inform ways to expand access to GGT and counseling for ill patients safely and effectively. Ultimately, this knowledge will foster scalable approaches to genetic and genomics care for a variety of medical conditions, address the evolving role of GCs, while promoting improved access and delivering on the promise of personalized care.

Dana-Farber Cancer Institute

NOT APPLICABLE

93.172 - Human Genome Research

National Human Genome Research Institute (NHGRI) [HHS - NIH]

Boston, Massachusetts 022155418 United States

Single Zip Code

Investigator-Initiated Research on Genetic Counseling Processes and Practices (R01, Clinical Trial Optional) (RFA-HG-20-048)

Amendment Since initial award the total obligations have increased 276% from $854,202 to $3,208,986.