COMET Enrollment Opens to Explore Psychological Impact of Genetic Testing

Patient enrollment has opened for the COMmunication and Education in Tumor Profiling COMET study, the ECOG-ACRIN Cancer Research Group has announced. The study will determine if online genetic self-education can reduce patients’ tumor gene testing-associated stress and anxiety.

“This study is looking at the process of cancer patients going through tumor gene testing, and essentially, gathering data on their hopes and expectations going into the testing experience, and then looking at what happens to them coming out of the experience,” said lead COMET researcher Angela Bradbury, MD, a medical oncologist at the University of Pennsylvania, in the ECOG news release.

Tumor gene testing is becoming a more common part of treatment decision-making, but little is known about the psychological distress caused by testing and test results. COMET researchers aim to address two research questions to help address that knowledge gap. First, whether or not patient self-education with a guided online module about gene testing, somatic and germline mutations, and treatment options, can reduce psychological distress. And second, whether expert genetic counseling via telephone for patients with germline mutations, which are rare, can serve as a workaround for the shortage of expert genetic counselors for these patients at community-based oncology practices.

The quality-of-life study is open only to newly-enrolled participants in the separate NCI-MATCH precision medicine cancer trial, since COMET participants must not yet have received their MATCH trial tumor gene test results. COMET participants must enroll within 2 weeks of enrollment in MATCH.

The NCI-MATCH trial has 24 study arms, each testing a combination or monotherapy that targets specific gene mutations involved in tumor progression.

COMET researchers hope to enroll a total of 500 patients from among the 5,000 participants sought for the NCI-MATCH study. Four hundred COMET patients will participate in the genetic education study and separately, 100 others will participate in a small pilot study of genetic expert counseling by telephone for patients in whom a germline mutation is identified.

As of October 16, 2016, 230 patients had enrolled in MATCH, an ECOG-ACRIN official told OncoTherapy Network.

The studies are funded by the US National Cancer Institute (NCI).