Symptoms and General Pathology

All Conditions

Recurrence

Participants receive usual care. This consists of physicians ordering GTT for patients and reviewing the results without the GTB being involved.

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.

Best Practice

Chart Abstraction

Physicians access genomic testing education materials

Educational Intervention

Genomic Profile

Interview

Questionnaire Administration

Patients undergo genomic tumor board review

Tumor Board Review

Patricia O'Kane

Dana Sparks

Site Public Contact

Shahzad Siddique

Catherine A. Ronaghan

Jami A. Fukui

John M. Schallenkamp

Bryan A. Faller

Vamsi K. Vasireddy

Joshua Lukenbill

Gary C. Doolittle

Rose A. Juhasz

Bret E. Friday

Pamala A. Pawloski

Jay W. Carlson

Charles S. Kuzma

Michael Humeniuk

Francis J. Cuevas

Luis J. Santos Reyes

Jens Rueter

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.

Does the Use of a Genomic Tumor Board Increase the Number of Patients Who Receive Genome-Informed Treatment

A Cluster Randomized Trial Comparing an Educationally Enhanced Genomic Tumor Board (EGTB) Intervention to Usual Practice to Increase Evidence-Based Genome-Informed Therapy

Evidence-based genome-informed therapy is defined as the use of a treatment that targets a genomic variant for which there is sufficient data to support actionability. This is a patient-specific measure determined through blinded central review of patient data, following the schemas in the protocol. An independent panel of investigators blinded to the study arm assignment of the study participant will evaluate redacted data from each subject for determination of the primary endpoint. Data supporting the primary endpoint are obtained from the genomic tumor test results PDF, pathology report, primary tumor type, and the S2108CD Treatment Form as well as curated evidence plus evidence level (tier) designation from the Jackson Labs Clinical Knowledge Base.

Measured by 3-item scale assessing physician confidence in genomic knowledge and ability to explain genomic concepts/make treatment recommendations. This assessment is on the S2108CD Genomic Testing Questionnaire.

The physician experience using genomic tumor testing in practice will be assessed using selected items from the National Survey of Precision Medicine in Cancer Treatment, included on the S2108CD Genomic Testing Questionnaire.

Overall survival on study will be measured from registration until death due to any cause.

Overall survival on new anticancer therapy will be measured from the time new anticancer therapy is initiated on study until death due to any cause.

Time to treatment discontinuation on study will be measured as the time from registration until the last dose recorded or death.

time to treatment discontinuation on new anticancer therapy will be measured as the time from registration until the last dose recorded or death.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Does the Use of a Genomic Tumor Board Increase the Number of Patients Who Receive Genome-Informed Treatment	NCT05455606	Advanced Malign... Metastatic Mali... Recurrent Malig... Refractory Mali...	Best Practice Chart Abstracti... Educational Int... Genomic Profile Interview Questionnaire A... Tumor Board Rev...	18 Years -	SWOG Cancer Research Network
Does the Use of a Genomic Tumor Board Increase the Number of Patients Who Receive Genome-Informed Treatment	NCT05455606	Advanced Malign... Metastatic Mali... Recurrent Malig... Refractory Mali...	Best Practice Chart Abstracti... Educational Int... Genomic Profile Interview Questionnaire A... Tumor Board Rev...	18 Years -	SWOG Cancer Research Network

Spots Global Cancer Trial Database for tumor board review