Communication Methods for Genetic Testing in Colorectal Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This clinical trial compares patient (proband)-mediated communication to provider-mediated communication for improving genetic testing in first-degree relatives of patients with newly diagnosed colorectal cancer. It is estimated that 30% of cases of colorectal cancer have a genetic basis and about 15% of these patients have a disease-causing (pathogenic) inherited (germline) variant in a cancer susceptibility gene. Most individuals carrying a pathogenic germline variant are unaware of their cancer risk and may not meet guidelines for genetic testing. Identifying pathogenic germline variants or hereditary cancer syndromes in cancer patients has important implications for their at-risk relatives who may not know that they are at high risk for cancer. The burden of communicating this risk to first-degree relatives often falls on the patients, who may lack sufficient knowledge to correctly share and explain their genetic test results. Receiving provider-mediated communication of genetic testing results may be more effective at communicating genetic risk to first-degree relatives than the usual practice of proband-mediated communication.
Who Is on the Research Team?
Frank A Sinicrope
Principal Investigator
Alliance for Clinical Trials in Oncology
Are You a Good Fit for This Trial?
This trial is for adults (18+) recently diagnosed with stage I-IV colon or rectal cancer who have at least two living close relatives they are willing to inform about their diagnosis. Participants must speak English or Spanish and not have had genetic testing in the past 2 years.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Genetic Testing
Probands undergo collection of blood samples and genetic testing on study
Communication Intervention
FDRs receive either proband-mediated or provider-mediated communication about the proband's genetic testing results
Follow-up
Probands are followed for up to 3 years and FDRs are followed for up to 1 year to monitor outcomes such as disease prevention efforts and disease-free survival
What Are the Treatments Tested in This Trial?
Trial Overview
The study compares two ways of sharing genetic test results: patients telling their own family members versus healthcare providers communicating this information directly. It involves surveys, genetic testing, education, and collecting biological samples.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Active Control
FDRs receive provider-mediated communication about the proband's genetic testing results.
Probands undergo collection of blood samples and genetic testing on study.
FDRs receive proband-mediated communication about the proband's genetic testing results.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Alliance for Clinical Trials in Oncology
Lead Sponsor
National Cancer Institute (NCI)
Collaborator
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