Family Communications After Genetic Testing

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Accepted

Interventions

• Biospecimen Collection — PROCEDURE
  Undergo collection of blood samples
• Genetic Testing — OTHER
  Undergo genetic testing
• Communication Intervention — OTHER
  Receive proband-mediated communication
• Survey Administration — OTHER
  Ancillary studies

Study Details

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.

Key Dates

Start date

Apr 6, 2026

Status verified

Jun 2026

Primary completion

Nov 5, 2029

Completion

Nov 5, 2032

Study Design

Enrollment

4,186 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SCREENING

Arms

• Experimental: Step 1 (biospecimen collection, genetic testing)
  Probands undergo collection of blood samples and genetic testing on study.
• Active Comparator: Step 2, Arm A (proband-mediated)
  FDRs receive proband-mediated communication about the proband's genetic testing results.
• Experimental: Step 2, Arm B (provider-mediated)
  FDRs receive provider-mediated communication about the proband's genetic testing results.

Primary Outcome Measure

Proportion of eligible first-degree relatives (FDRs) of the affected proband who underwent genetic testing [ Time Frame: Within 6 months of proband randomization ]

Central Contacts

• Rachel Wills
  773-702-9814
  [email protected]

Locations (242)

Find similar trials in Anchorage, AK

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