Research Tools

This document is the study protocol of the Institutional and Professional Impact of Genomic Sequencing in Cancer Care study. Appendices include the following: Email Notification to Oncologists about Study Implementation Information Sessions, Email Invitation to Oncologists to Participate in Cognitive Testing, Email Invitation to Attend an Initial Clinical Genomics Evaluation Committee Meeting, Physician Baseline Survey, Email Notification to Oncologists to Complete the Baseline Survey, Follow up Email Notification to Oncologists to Complete the Baseline Survey, New Physician Post-disclosure Survey – Informative Results, Old Physician Post-disclosure Survey, Physician Post-Disclosure Survey – Uninformative Results, Email Notification to Oncologists to Complete the Post-disclosure Survey, Reminder Email Notification to Oncologists to Complete the Post-disclosure Survey, Email Invitation for the Baseline Qualitative Interview, and Email Invitation for the One-Year Follow up Qualitative Interview.

This document is the Use of Sequencing to Guide the Care of Cancer Patients study protocol. Appendices include the following: Measures for Patient Baseline, Email Notification to Patients to Complete Baseline Survey, Measures for Patient Post-Disclosure Survey in the Setting of Uninformative Sequencing Results, Measures for Patient Post-Disclosure Survey in the Setting of Informative Sequencing Results, Training plan for CRCs, Patient Baseline Reminder Letter, Patient Post-Disclosure Email Invitation and reminder email, Patient Post-Disclosure Reminder invitation and reminder letter, CanSeq Patient Informed Consent Interview Guide, Patient Information brochure, Post-Disclosure email introduction, ACMG Guidelines, Patient Preferences Communication, Gift Card Thank You Letter, and Patient Post-Disclosure Interview.

The Personalized Oncology Through High-throughput Sequencing: MI-ONCOSEQ (Michigan Oncology Sequencing Center) (formerly known as “Personalized Medicine Based on Molecular Profiling of Patients with Cancer”) study implements a mechanism for patients who have advanced or refractory cancer to undergo tumor sequencing, sequence analysis, and return of clinically significant sequence results to patients, their families and the clinicians. This document is the revised study protocol. It contains 5 appendices: 1. Study Calendar; 2. Sample Molecular Report; 3. Adverse Event Reporting Form; 4. Genes Queried; 5. Genetic Information Nondiscrimination Act.

The Personalized Medicine Based on Molecular Profiling of Patients with Cancer implements a mechanism for patients who have advanced or refractory cancer to undergo tumor sequencing, sequence analysis, and return of clinically significant sequence results to patients, their families and the clinicians. This document is the study protocol. It contains 5 appendices: 1. Study Calendar; 2. Sample Molecular Report; 3. Adverse Event Reporting Form; 4. Genes Queried; 5. Genetic Information Nondiscrimination Act.

This survey covers disclosure of genetic test results to family members, plans for follow up care, plans for behavior changes, demographic information, and other topics. It can be administered using REDCap.

This semi-structured interview guide is intended for use with gene drive technology (GDT) experts. It was developed using ethical arguments identified by the authors via literature review. It employs open-ended questions on several GDT topics such as: benefits, risks, stakeholder involvement, and governance.

Genomics ADvISER is a digital decision aid for use in the delivery of genomic counseling. It is intended as a supplement to genomic counseling with a counselor. Genomics ADvISER guides users through a ten-minute video of basic genomic sequencing concepts and five categories of secondary findings followed by brief interactive questionnaires about values, knowledge, and decision-making needs. Please contact the authors of the study to use this tool.

The CSER Organizational Readiness to Change Assessment measures the readiness of healthcare systems to implement clinical sequencing. It is comprised of 19 items from an existing measure, the ORCA (Organizational Readiness to Change Assessment, and should be administered at 0-8 weeks since study initiation to six to ten executives, administrators, managers, or clinicians at each site participating in your project.

This parent consent form was approved by the Institutional Review Board for the Baylor College of Medicine and Affiliated Hospitals for use in the Incorporation of Genomic Sequencing into Pediatric Cancer Care Study. The purpose of the study was learn how to report and use clinical exome sequencing test results for childhood cancer patients.