4186 Participants NeededMy employer runs this trial

Communication Methods for Genetic Testing in Colorectal Cancer

Recruiting at 322 trial locations
RW
Overseen ByRachel Wills
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Alliance for Clinical Trials in Oncology
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

FA

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

I have another cancer at the same time as my main diagnosis.
I have not had genetic testing or been diagnosed with hereditary colon cancer in 2 years.
I am 18 years old or older.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Genetic Testing

Probands undergo collection of blood samples and genetic testing on study

Up to 3 years
Multiple visits as needed for sample collection and testing

Communication Intervention

FDRs receive either proband-mediated or provider-mediated communication about the proband's genetic testing results

6 months

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

Up to 3 years

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

Group I: Step 2, Arm B (provider-mediated)Experimental Treatment2 Interventions
Group II: Step 1 (biospecimen collection, genetic testing)Experimental Treatment2 Interventions
Group III: Step 2, Arm A (proband-mediated)Active Control2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Alliance for Clinical Trials in Oncology

Lead Sponsor

Trials
521
Recruited
224,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+