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โ† Trials
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Family Communications After Genetic Testing

RecruitingNAAges 18 Years - anyAllAlliance for Clinical Trials in Oncology
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In plain words

What the trial is, and whether it could suit you

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 s

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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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What it tests

  • Biospecimen Collection
  • Genetic Testing
  • Communication Intervention
  • Survey Administration
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Where

360 sites
Anchorage Associates in Radiation Medicine
Anchorage, United States
Alaska Breast Care and Surgery LLC
Anchorage, United States
Alaska Oncology and Hematology LLC
Anchorage, United States
Alaska Women's Cancer Care
Anchorage, United States
Katmai Oncology Group
Anchorage, United States
Providence Alaska Medical Center
Anchorage, United States
Fairbanks Memorial Hospital
Fairbanks, United States
Cancer Center at Saint Joseph's
Phoenix, United States

โ€ฆand 352 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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