Metastatic Malignant Solid Neoplasm Clinical Trial
Official title:
A Cluster Randomized Trial Comparing an Educationally Enhanced Genomic Tumor Board (EGTB) Intervention to Usual Practice to Increase Evidence-Based Genome-Informed Therapy
This clinical trial studies how well an educationally enhanced genomic tumor board (EGTB) intervention works to increase the number of patients with solid tumors that have come back (recurrent), do not respond to treatment (refractory), have spread to other parts of the body (metastatic), or are newly diagnosed and spread to other parts of the body (advanced) who receive genome-informed treatment. Genome-informed treatment refers to treatment based on the information found in genomic tumor test results. This study compares the usual approach to reviewing genomic tumor test results with the approach of having a genomic tumor board (GTB) review the test results. A GTB is team of doctors and scientists that have experience in understanding genomic changes and review genomic tumor test results. The tumor board helps to suggest whether there are other cancer treatment options based on patient genetic test results. The usual approach is to review genomic tumor test results without the GTB being involved. This study may help researchers learn if using a GTB enhances the treatment decision making process within 6 months of joining the study. This study may also help researchers learn if using the GTB increases doctors' understanding of genomic tumor test results and increases doctors' comfort level with genomic tumor tests.
PRIMARY OBJECTIVE: I. To determine whether an EGTB intervention compared to usual practice increases the proportion of patients who receive evidence-based genome-informed therapy within 6 months after registration to the study. SECONDARY OBJECTIVES: I. To compare physician genomic confidence and physician experience with genomic tumor testing (GTT) between arms at baseline and end of study. II. To compare clinical outcomes between arms by assessing patient survival and time to treatment discontinuation. III. To compare physician assessment of evidence-based genome-informed therapy to the central study team determination of evidence-based genome-informed therapy, both overall and separately by arm. IMPLEMENTATION OBJECTIVES: I. To assess the utilization of GTT and implementation of the EGTB intervention into clinic workflow in order to better understand barriers and facilitators at Recruitment Centers assigned to the active intervention arm using a mixed-methods approach. II. To assess the evolution of GTT utilization within clinic workflows at recruitment centers assigned to the usual practice (control) arm using a mixed-methods approach. OUTLINE: Study clinics are randomized to 1 of 2 arms. Participants receive interventions based on this randomization. ARM 1: Participants receive usual care. This consists of physicians ordering GTT for patients and reviewing the results without the GTB being involved. ARM 2: Patients and physicians receive the EGTB intervention. This is comprised of 2 components: the structured GTB and the supporting education. Physicians submit cases for discussion to the GTB within 2 weeks of GTT results. The GTB sessions are held weekly and conducted virtually over a video-conferencing platform. Each case presentation is 10 to 15 minutes long, and 4 to 6 cases are discussed during each 60 minute GTB session. GTT results and clinical data are presented and expert interpretation of genomic test results is provided to help prioritize potential treatment options and provide a framework for interpretation. Supporting education materials are also available online to participants to support GTT decision making. Physicians are followed until the end of the study or through 6 months after their last patient was registered to the study, whichever is later. Patients are followed for 24 months after registration or until a criterion for removal from protocol participation is met, whichever comes first. ;
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