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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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 3 years, 1 year
  • Procedures mentioned: Questionnaires, Blood draws

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "To evaluate the completion rate of a Social Determinants of Health questionnaire with patient directed questions ."
  • "OUTLINE: STEP 1: Patients (probands) undergo collection of blood samples and genetic testing on study."
  • "Probands are followed for up to 3 years and FDRs are followed for up to 1 year"
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares two ways to share genetic test results with family: through the patient or through a health care provider. It looks at which way helps more close relatives get genetic testing. It is for adults newly diagnosed with colon or rectal cancer and their parents, siblings, or children.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Patients and relatives must be at least 18 years old and able to speak and read English or Spanish.
  • Patients must have stage I to IV colon or rectal adenocarcinoma, a type of cancer confirmed by a tissue test, diagnosed within 3 months before signing up. Stage 0 cancer is not allowed.
  • Patients may have had other cancers before or have another cancer now, including more than one colon cancer.
  • Patients must not have had testing for inherited gene changes in the past 2 years or have a known inherited colon cancer syndrome.
  • Patients must have at least 2 living parents, siblings, or children who qualify. Patients must be willing to share their cancer diagnosis with them.
  • Patients must not have known dementia or thinking problems. They must be able to understand the test results and explain them to family. Other conditions that seriously limit judgment may prevent joining.
  • For step 2, patients must have a test result showing an inherited gene change that raises cancer risk.
  • Relatives must live in the United States, have never had testing for inherited gene changes, and have no known inherited colon cancer syndrome.

Who can't join

    Simplified for readability. The official criteria below are what the study team uses.

    Official eligibility criteria

    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: \-

    Study sites (353)

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