Family Communications After Genetic Testing

Recruiting now · Not applicable

Conditions studied: 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

In brief

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 facts

Study ID

NCT07143487

Run by

Alliance for Clinical Trials in Oncology

People needed

4186

Starts

2026-04-06

Expected to finish

2032-11-05

Last updated by the study team

2026-08-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

Where it is running

• Alaska Breast Care and Surgery LLC — Anchorage, Alaska, United States (enrolling)
• Alaska Oncology and Hematology LLC — Anchorage, Alaska, United States (enrolling)
• Alaska Women's Cancer Care — Anchorage, Alaska, United States (enrolling)
• Katmai Oncology Group — Anchorage, Alaska, United States (enrolling)
• Providence Alaska Medical Center — Anchorage, Alaska, United States (enrolling)
• Fairbanks Memorial Hospital — Fairbanks, Alaska, United States (enrolling)
• Cancer Center at Saint Joseph's — Phoenix, Arizona, United States (enrolling)
• Mercy Hospital Fort Smith — Fort Smith, Arkansas, United States (enrolling)
• CARTI Cancer Center — Little Rock, Arkansas, United States (enrolling)
• Mission Hope Medical Oncology - Arroyo Grande — Arroyo Grande, California, United States (enrolling)
• Providence Saint Joseph Medical Center/Disney Family Cancer Center — Burbank, California, United States (enrolling)
• Mercy Cancer Center - Carmichael — Carmichael, California, United States (enrolling)
• Mercy San Juan Medical Center — Carmichael, California, United States (enrolling)
• Mercy Cancer Center - Elk Grove — Elk Grove, California, United States (enrolling)
• Mercy Cancer Center — Merced, California, United States (enrolling)
• Providence Queen of The Valley — Napa, California, United States (enrolling)
• Mercy Cancer Center - Rocklin — Rocklin, California, United States (enrolling)
• Mercy Cancer Center - Sacramento — Sacramento, California, United States (enrolling)
• Pacific Central Coast Health Center-San Luis Obispo — San Luis Obispo, California, United States (enrolling)
• Mission Hope Medical Oncology - Santa Maria — Santa Maria, California, United States (enrolling)
• Providence Medical Foundation - Santa Rosa — Santa Rosa, California, United States (enrolling)
• Providence Santa Rosa Memorial Hospital — Santa Rosa, California, United States (enrolling)
• Saint Helena Hospital — St. Helena, California, United States (enrolling)
• Saint Joseph's Medical Center — Stockton, California, United States (enrolling)
• Anchorage Associates in Radiation Medicine — Anchorage, Alaska, United States (enrolling)

Full record on ClinicalTrials.gov

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