With Carol Weil, JD, in the NCI Cancer Diagnosis Program
By Sarah DiGiulio
The NCI started enrolling patients in the NCI-MATCH trial in August 2015 with the goal of finding better treatments for patients with cancer based on the molecular profiles of their tumors rather than their tumor types. The trial marks a big step for advancing the science of targeted therapies and personalized medicine. But researchers, physicians, and patient advocates all say there is still much work needed to better educate patients about the delivery of such medicine.
"We need to develop best practices around how to communicate suspected germline information to patients who undergo tumor testing—what information patients want and need to know to determine whether to undergo confirmatory germline testing and what patient characteristics are associated with lower or higher levels of stress, anxiety, or depression around the receipt of this information," explained Carol Weil, JD, Program Director of Ethical and Regulatory Affairs in the Cancer Diagnosis Program in the Division of Cancer Treatment & Diagnosis at NCI.
In February 2015, Weil and a committee of oncologists, geneticists, bioethicists, and patient advocates convened to discuss ethical controversies of the trials that would be part of NCI-MATCH. The attendees realized they needed to find better ways to help patients better understand the results of their genetic data that was part of the trial.
"More empirical data were needed to understand both patient and physician attitudes and preferences about the receipt of genetic findings," Weil said. "We need better understanding of the relative benefits and risks of conveying tumor profiling information to patients."
And that is why the COMmunication and Education in Tumor profiling study (COMET) was created, she said. Weil told Oncology Times more about the specific questions COMET seeks to answer and how it works.
1. What is COMET?
"COMET tests the hypothesis that the knowledge patients gain by completing a self-guided, mobile-friendly, and tiered online genetic education program before getting their tumor test results will be associated with lower levels of testable distress, including anxiety, depression, and cancer worry.
"COMET Step 1 is a randomized controlled trial of a web-based genetic education intervention that will be administered to [one arm of] NCI-MATCH patients prior to receiving their genetic test results from the tumor sequencing required in NCI-MATCH. The other arm will receive 'usual care' (i.e., whatever the treatment center normally discusses with patients undergoing tumor profile testing). COMET Step 1 allows us to address the lack of empirical data regarding patients' experience with genetic testing, and learn how to mitigate the distress many patients carry through the tumor profiling process.
"COMET [also] includes a small pilot remote genetic counseling study known as COMET Step 2. As we continue to incorporate whole genome and whole exome sequencing technologies into oncology clinical trials to match patients with treatments that can potentially target their particular tumor mutations, it will be more and more imperative to ensure the availability of genetic counseling services for those with incidental findings. Particularly in the rural and community hospital setting, sites often do not have sufficient numbers of genetic counselors.
"[This] COMET remote genetic counseling pilot explores the feasibility and preliminary outcomes of providing genetic counseling by telephone to advanced cancer patients in whom a potential or suspected germline mutation is found upon tumor profiling in NCI-MATCH."
2. Is there a current standard of care in terms of educating patients about the results of the genetic tests they receive?
"In terms of a standard for genetic counseling when undergoing tumor profiling—there is not really a standard of care.
"[ASCO] has recommended that patients be counseled in advance of gene panel testing about the possibility of suspected germline findings, but there are not really any developed models for engaging in this complex, and often emotionally charged, communication when there is so much uncertainty about the significance of potential findings."
3. Why would you say COMET is an important part of the MATCH trial?
"Most NCI-MATCH patients won't actually 'match.' They will undergo tumor testing only to discover there is no actionable mutation in their genomic profile for which there is an investigational therapy available in the NCI-MATCH trial.
"As NCI-MATCH patients typically have advanced and/or recurrent cancer, this news could be devastating. It is our hope that participating in COMET will provide some measure of comfort and empowerment for these cancer patients in that they may have better understanding of their personal and family genetics, and can facilitate communication with family members who could medically benefit from this information.
"Also, COMET will give patient reported outcomes on managing potential germline mutations when cancer patients undergo tumor testing. The results will help us design better policies for communicating individual genetic findings in future clinical trials that address the very real emotions and needs of advanced cancer patients."