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.

National Cancer Institute (NCI)

SWOG Cancer Research Network

Neoplasms

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

abstraction of breast cancer patients with de-identified data

chart abstraction

Linda Sutton, MD

Currently many patients with HER2+ Breast Cancer do not have the opportunity to be evaluated by a medical oncologist for neo-adjuvant treatment due to the current lack of care coordination between the surgeon/surgical oncologist and the medical oncologists.

This project will evaluate the feasibility to enhance knowledge that drives adoption of evidence based care, and evaluate the improvement in care coordination between oncologists and surgeons for patients with HER2+ Breast Cancer in the Neo-Adjuvant setting.

The HER2+ Breast Cancer Neo-Adjuvant Coordination of Care Program will evaluate the feasibility, effectiveness, and adoption of evidence based medicine for patients with HER2+ breast cancer through a care coordination application hosted on CECity's MedConcert™ platform. The goal is to implement evidence into practice using existing patient data, and to improve care based on knowledge that will enable care coordination between medical oncologists and surgeons.

PHASE 1: Workflow Design The steering committee from Duke has created a workflow process related to the HER2+ Neo-Adjuvant Therapy Treatment. The goal of the workflow is to establish a coordinated approach to care and identifying key steps in the process. The workflow will identify if the patient had a timely engagement of the multidisciplinary team; if a pre-treatment assessment was performed; if neo-adjuvant therapy treatment was prescribed; if appropriate management and adherence to treatment as prescribed occurred; if surgery was performed and the identification of the type of surgery; and if any subsequent therapy was prescribed. Data collection will be performed at each of the steps in the workflow.

PHASE 2: Engagement Three sites were identified to participate in the project. Each is affiliated with the Duke Cancer Network and are free standing hospital systems and clinics. A coordinator will be designated at each site to guide the process, enter data and communicate patient progress to the sites multidisciplinary project team. Routine communication will be maintained between each site and the project team to ensure timely resolution of any issues or to answer questions.

PHASE 3: Feedback Performance measures have been identified for which data will be collected and aggregated. The data will be displayed in a performance monitor in the CECity MedConcert™ application to provide feedback to providers on their performance related to the measures. Providers will also be provided access to educational resources and improvement opportunities through the application.

PHASE 4: Assessment of Change and Dissemination of Findings Currently, many patients with HER2+ Breast Cancer do not have the opportunity to be evaluated by an oncologist for neo-adjuvant treatment because of a lack of coordinated care between surgeons and oncologists. This project will evaluate adopting evidence-based medicine for patients with HER2+ through the use of a coordinated care application. The goal is to facilitate greater coordination of care between oncologists and surgeons and to identify interventions for improved care. A final report will outline the results of the coordinated care approach. The results of this QI initiative will be developed into a manuscript for publication.

HER2+ Breast Cancer Neo-Adjuvant Coordination of Care Program

Multiple measurements will be aggregated from across study sites to evaluate coordination of care efforts across different disciplines involved in the care of a breast cancer patient.This evaluation will result in the formation of a multidisciplinary approach to care for breast cancer subjects.

Duke University

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma

Carcinoma, Renal Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Kidney Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

chart abstraction will be conducted post education intervention component.

chart abstraction will be conducted pre and post education intervention to assess efficacy of education at point of care

Educational Program

Lisa Criscione-Schreiber

This study will consist of three parts: 1) a retrospective chart review of patients treated for mRCC from July 2013 until the start of the educational intervention; 2) an educational program for DCN community oncology providers and DCN community patients with mRCC, lasting 8 - 10 months, and 3) a second retrospective chart review of patients treated for mRCC starting at the time of the educational intervention until the intervention is completed.

The initial retrospective cohort will serve as the pre-education control, and the second cohort will be the experimental group to assess the efficacy of the educational intervention to change care of patients with mRCC.

Chart Reviews. This study will begin with a multi-site chart review conducted at the Duke Cancer Network affiliated sites. The chart review will begin in late fall, 2015. The Duke Cancer Network team will perform chart abstraction for this study, with a goal of reviewing at least 60 charts of patients treated between July 2013 and October 2015.

The second data collection period will collect data on patients with mRCC seen at DCN sites after the date in fall 2015 when the educational intervention is rolled out. The target will again be at least 60 charts of patients treated during the time the educational intervention is actively available.

NCCN Renal Cell Registry

Novel Educational Interventions for Community Oncologists & Patients: Optimizing Renal Cell Carcinoma Outcomes Through Engagement

Improvement in the percentage of patients receiving appropriately prescribed first line therapy for metastatic renal cell cancer (mRCC)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
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
HER2+ Breast Cancer Neo-Adjuvant Coordination of Care Program	NCT02616133	Breast Cancer	chart abstracti...	-	Duke University
HER2+ Breast Cancer Neo-Adjuvant Coordination of Care Program	NCT02616133	Breast Cancer	chart abstracti...	-	Duke University
NCCN Renal Cell Registry	NCT02677337	Renal Cell Carc...	chart abstracti... Educational Pro...	18 Years -	Duke University
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 chart abstraction