This is a hybrid decentralized, single-arm, interventional study designed to evaluate the impact of precision medicine navigation and reflexive expert review of next-generation sequencing (NGS) for patients with stage IV solid tumor malignancies (breast, lung, colorectal, and bladder cancers). The purpose of this study is to investigate whether intervention from a centralized precision oncology navigator and expert review of NGS results by the precision oncology pharmacist will increase ordering of Level 1/2 genome informed therapy (GIT) compared to an estimated historical rate of 15%. Secondary endpoints will assess the impact of a centralized precision oncology navigator and expert review of NGS results on enrollment in biomarker-directed clinical trials and overall survival at 2 years after return of NGS results. The study will take approximately 12 months for enrolment and 2 years of follow-up after the date of NGS results.
Despite data supporting a survival benefit in many cancers, rates of NGS testing and subsequent GIT are reported to be low in real-world data sets. Rates of multigene panel-based testing and targeted therapy use are reported to be higher at NCI-designated cancer centers compared to other practice types, even when they are associated with a "hub" site. Molecular tumor boards have demonstrated improvements in overall survival in lung cancer, but these models rely on consults being placed by treating physicians and/or significant institutional resources. Many studies evaluating interventions to increase the use of genome informed therapy (GIT) focus on a single cancer type, thereby hindering the ability to operationalize supportive interventions broadly across all cancer types. Given the collective body of data supporting meaningful clinical improvements when patients have access to GIT, we want to study if interventions that make NGS test ordering and interpretation easier for clinicians will increase the rate of orders for GIT. The use of a centralized precision oncology navigator to facilitate completion of NGS testing, expert clinical review from a clinical pharmacist, and documented clinical decision support embedded in the electronic health record represents a unique and more easily scalable model than full molecular tumor board reviews.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
500
Expert reflexive review of next-generation sequencing (NGS) results will be visible in electronic health records (EPIC) for provider review at the University of North Carolina Health System. Expert review will include recommendations for Genome-informed therapy (GIT), identification of available clinical trials, recommendations for additional testing, and/or referrals for genetic counseling.
Blood or tissue samples will be collected for next-generation sequencing (NGS) per standard of care.
The precision oncology navigator will coordinate the collection of blood and /or tissue for next-generation sequencing (NGS), as well as order the NGS if not already ordered. Precision oncology navigator will also assist in NGS financial aid applications, if applicable.
Lineberger Comprehensive Cancer Center, University of North Carolina
Chapel Hill, North Carolina, United States
RECRUITINGThe rate of genome informed therapy (GIT) orders
The rate of genome informed therapy (GIT) orders for Level 1/2 GIT will be compared against an estimated baseline historical GIT order.
Time frame: 2 years
Overall survival (OS)
Overall survival of enrolled patients who receive precision oncology navigation order facilitation and reflexive expert review of their Next Generation Sequencing (NGS) result reporting to the date of death for any cause.
Time frame: 2 years
The rate of genome informed therapy (GIT) orders by site
The rate of orders for Level 1/2 genome informed therapy (GIT) at each site.
Time frame: 2 years
The rates of consent to UNC Health biomarker-selective clinical trials
The rates of consent to the University of North Carolina (UNC) Health biomarker-selective clinical trial will be calculated. A subgroup analysis of rates of consent by site may be performed.
Time frame: 2 years
The reasons for non-consent
Among enrolled patients, if a biomarker-selective clinical trial is identified on expert review of Next Generation Sequencing (NGS) results, reasons for non-consent will be collected.
Time frame: 2 years
Overall Survival in subjects who are eligible for Level 1/2 genome-informed therapy (GIT)
To determine the overall survival (OS) after the return of Next Generation Sequencing (NGS) results in those deemed eligible for Level 1/2 genome-informed therapy (GIT) in patients who receive precision oncology navigator order facilitation and reflexive expert review of results.
Time frame: 2 years
The rates of referrals for full Molecular Tumor Board
The rates of referrals for full Molecular Tumor Board review in patients who receive precision oncology navigator order facilitation and reflexive expert review of results will be calculated.
Time frame: 2 years
The combined rate of orders for Level 1/2 GIT and consent to biomarker-directed clinical trials
To determine the combined rate of orders for Level 1/2 genome-informed therapy (GIT) and consent to biomarker-directed clinical trials open at UNC. Health site in patients who receive precision oncology navigator order facilitation and reflexive expert review of results.
Time frame: 2 years
The time between the date of NGS results and the Level 1/2 GIT order date
The time between the date of Next Generation Sequencing (NGS) results and the order date of Level 1/2 GIT will be calculated for those with GIT orders and reported by the site. The median time will be reported for enrolled patients.
Time frame: 2 years
Reasons for lack of Level 1/2 GIT orders in eligible subjects
Reasons why patients deemed eligible for Level 1/2 genome-informed therapy (GIT) by expert review do not have orders for GIT will be collected.
Time frame: 2 years
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