A Precision Oncology Navigation and Expert Review Intervention for Improving Referral to Genome Informed Therapy among Patients with Stage IV Lung, Colorectal, Breast or Bladder Cancers, PROGRESS Trial

PRIMARY OBJECTIVE:

I. To assess whether the use of a precision oncology navigator and reflexive expert review of next generation sequencing (NGS) results will increase the rate of orders for level 1/2 genome informed therapy (GIT) when compared against an estimated historical rate of level 1/2 GIT orders.

SECONDARY OBJECTIVES:

I. To determine the overall survival at two years after the return of NGS results of enrolled patients who receive precision oncology navigation order facilitation and reflexive expert review of their NGS results.

II. To determine the rate of orders for level 1/2 GIT between large versus (vs) small sites in patients who receive precision oncology navigator order facilitation and reflexive expert review of results.

III. To determine the rate of consent to biomarker-selective clinical trials open at a University of North Carolina (UNC) Health site in patients who receive precision oncology navigator order facilitation and reflexive expert review of results.

IV. To describe reasons that patients did not enroll on biomarker-selective trials if identified by expert review.

V. To describe reasons why patients deemed eligible for level 1/2 GIT do not have orders for GIT.

VI. To determine the overall survival (OS) at two years after the return of NGS results in those deemed eligible for level 1/2 GIT in patients who receive precision oncology navigator order facilitation and reflexive expert review of results.

VII. To determine the rate of referrals to the molecular tumor board (MTB) in patients who receive precision oncology navigator order facilitation and reflexive expert review of results.

VIII. To determine the combined rate of orders for level 1/2 GIT and consent to biomarker directed clinical trials open at a UNC Health site in patients who receive precision oncology navigator order facilitation and reflexive expert review of results.

IX. To determine the time between NGS result and the date of order of GIT in the population who have an order for GIT.

X. To determine the percentage of patients who are eligible to level 1/2 GIT as a result of precision oncology navigator order facilitation and reflexive expert review of results.

EXPLORATORY OBJECTIVES:

I. To measure patient-level knowledge of clinical trials to evaluate if patient-level knowledge changes after they participate in a clinical trial.

II. To measure patient-level attitudes towards clinical trials to understand if patient-level attitudes change after patient participation in a cancer clinical trial.

III. To measure patient-reported financial toxicity according to Functional Assessment of Chronic Illness Therapy (FACIT)’s Comprehensive Score for financial Toxicity (COST) as there are various costs associated with not only cancer care but cancer clinical trial participation.

OUTLINE:

Patients receive navigation services from a precision oncology navigator, who orders and/or facilitates NGS testing, aids patients in completing financial assistance paperwork, and follows up on issues or delays in NGS results. Patients then have their NGS results reviewed by a precision oncology pharmacist. Patients may receive tailored recommendations and/or referrals for level 1/2 GIT, additional testing, full MTB review, and/or available clinical trials and have the expert recommendations and referrals documented in their electronic medical record for review by their treating physician.

After completion of study intervention, patients are followed up every 6 months for 1 year and again at 24 months from the date of NGS results.