RecruitingNot ApplicableNCT07143487

Family Communications After Genetic Testing

Evaluation of Provider vs. Patient Mediated Cascade Genetic Testing of First-Degree Relatives of Patients With Newly Diagnosed Colorectal Cancer

Sponsor

Alliance for Clinical Trials in Oncology

Enrollment

4,186 participants

Start Date

Apr 6, 2026

Study Type

INTERVENTIONAL

Conditions

Stage IV Colorectal Cancer AJCC v8 Stage I Colorectal Cancer AJCC v8 Stage II Colorectal Cancer AJCC v8 Stage III Colorectal Cancer AJCC v8 Rectal Adenocarcinoma Stage III Colon Cancer AJCC v8 Stage IV Colon Cancer AJCC v8 Colorectal Adenocarcinoma Stage II Rectal Cancer AJCC v8 Stage III Rectal Cancer AJCC v8 Colon Adenocarcinoma Stage I Colon Cancer AJCC v8 Stage I Rectal Cancer AJCC v8 Stage II Colon Cancer AJCC v8 Stage IV Rectal Cancer AJCC v8

Summary

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria17

STEP 1 PROBANDS: Age >= 18 years
STEP 1 PROBANDS: Patients with a newly diagnosed (within 3 months of registration), primary colorectal adenocarcinoma, stage I to IV
Histologically proven stage I to IV colon or rectal adenocarcinoma (any T or N, M+). Tumors deemed to originate in the colon can extend into/involve the small bowel (e.g., those at the ileocecal valve). Tumors will be regarded as originating in the colon if the entire tumor is in the colon. In the case of rectal involvement, the cancer will be considered a rectal primary
Patients with more than one primary colon adenocarcinoma are eligible
STEP 1 PROBANDS: No patients with stage 0 or in-situ colorectal cancer
STEP 1 PROBANDS: Patients who have had prior malignancies are eligible, including non-invasive cancers
STEP 1 PROBANDS: Patients with synchronous second malignancies are eligible
STEP 1 PROBANDS: Have not received germline testing in the 2 years prior to enrollment or known hereditary colon cancer syndromes
STEP 1 PROBANDS: Patients must have at least 2 living FDRs who meet the eligibility criteria, with whom the patient is willing to share their cancer diagnosis
STEP 1 PROBANDS: In order to complete the mandatory patient-completed measures and view the video and receive genetic education and counseling, participants must be able to speak and read English or Spanish
STEP 1 PROBANDS: No known diagnosis of dementia or cognitive impairment. Persons with impaired decision-making capacity are ineligible as they need to be able to understand genetic test results, its implications for the patient and family, and explain genetic test results to their family members
* No persons with a known psychiatric or documented developmental disorder that affects cognitive or emotional functions to the extent that the capacity for judgment and reason is significantly diminished, such that they cannot participate based on the judgment of the treating physician
STEP 2 PROBANDS: Probands positive for a pathogenic germline variant (PGV) in a cancer susceptibility gene
FDRs: Age >= 18 years
FDRs: Have not previously received germline genetic testing or known hereditary colon cancer syndromes
FDRs: FDRs must reside within the United States, as genetic testing from LabCorp is only available to United States (U.S.) residents
FDRs: In order to complete the mandatory patient-completed measures, participants must be able to speak and read English or Spanish

Exclusion Criteria1

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Interventions

PROCEDUREBiospecimen Collection

Undergo collection of blood samples

OTHERGenetic Testing

Undergo genetic testing

OTHERCommunication Intervention

Receive proband-mediated communication

OTHERSurvey Administration

Ancillary studies