Rationale and study design for a randomized clinical trial of HOPE-Genomics, a web-based intervention to improve...

Genomic testing is rapidly being incorporated into cancer care. The results of somatic (tumor) and germline (normal) DNA testing can have implications for treatment, management of future cancer risk, and the health of family members. Despite these benefits, many patients fail to understand genomic concepts and their testing results. To address these knowledge gaps, we developed Helping Oncology Patients Explore (HOPE) Genomics. HOPE-Genomics is an interactive, web-based tool that 1) educates patients about genomics, 2) enables direct-to-patient return-of-results (ROR), and 3) facilitates sharing of genomic results within families. Herein we describe an NIH-funded randomized clinical trial (RCT) to test the intervention efficacy.

We will conduct a prospective, three-arm, RCT of HOPE-Genomics among cancer patients (n = 435) who have received somatic, germline or paired sequencing. Patients will be randomized into one of three arms: (1) Control (i.e., Usual Care), (2) return of results (ROR) through HOPE-Genomics and (3) pre-test genetic education and ROR through HOPE-Genomics. We will survey patients at 5 timepoints over 12 months. The primary study outcome will be patients' genetic testing recall at 10-day post-disclosure. Secondary outcome will be receipt of genomically-informed, guideline concordant care. Exploratory outcomes will include recall of genetic testing at 3-month post-disclosure, and general and cancer genetic knowledge.

Our hypothesis is that the use of HOPE-Genomics will result in higher rates of recalling genetic testing, better understanding of general genomic knowledge and higher uptake of evidence-based genetically guided care. If effective, HOPE-Genomics could serve as a scalable model for genomics education and care delivery.

ClinicalTrials.gov identifier NCT04905082.