Family genetics: who shares test results with relatives

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study compares proband-mediated communication to provider-mediated communication to increase germline testing among first-degree relatives of patients with newly diagnosed colorectal cancer. It focuses on patients with colorectal adenocarcinoma and aims to see if relatives are more likely to undergo testing when prompted by the patient versus by healthcare providers. Primary aims measure the proportion of relatives who complete germline testing at 6 months, while secondary aims look at disease-prevention actions at 12 months. Exploratory analyses will examine subgroup differences and the spectrum of pathogenic variants across multiple sites. The trial involves biospecimen collection, genetic testing, a communication intervention, and survey data collection at participating institutions.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

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Where it's running

• University of Alabama at Birmingham Cancer Center
  Birmingham, Alabama, United States Recruiting
• Anchorage Associates in Radiation Medicine
  Anchorage, Alaska, United States Recruiting
• Alaska Breast Care and Surgery LLC
  Anchorage, Alaska, United States Recruiting
• Alaska Oncology and Hematology LLC
  Anchorage, Alaska, United States Recruiting
• Alaska Women's Cancer Care
  Anchorage, Alaska, United States Recruiting
• Katmai Oncology Group
  Anchorage, Alaska, United States Recruiting

+315 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Rachel Wills
• Email: rwills@bsd.uchicago.edu
• Phone: 773-702-9814

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.