Family Communication After Genetic Testing for Colorectal Cancer
Family Communications After Genetic Testing
Recruiting
N/AInterventional Study
Colon AdenocarcinomaColorectal AdenocarcinomaRectal AdenocarcinomaStage I Colon Cancer AJCC v8Stage I Colorectal Cancer AJCC v8Stage I Rectal Cancer AJCC v8Stage II Colon Cancer AJCC v8Stage II Colorectal Cancer AJCC v8Stage II Rectal Cancer AJCC v8Stage III Colon Cancer AJCC v8Stage III Colorectal Cancer AJCC v8Stage III Rectal Cancer AJCC v8Stage IV Colon Cancer AJCC v8Stage IV Colorectal Cancer AJCC v8Stage IV Rectal Cancer AJCC v8
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Screening
Participants needed
4,186 (estimated)
Sponsor
Alliance for Clinical Trials in Oncology · Other
Who this trial is looking for
This trial is looking for patients with newly diagnosed colorectal cancer and their family members. Participants will help improve how genetic testing information is shared with relatives.
Are You a Good Fit for This Trial?
You may be able to join if
I am at least 18 years old.
I have been diagnosed with colorectal adenocarcinoma stage I to IV.
I have at least two living first-degree relatives I can share my diagnosis with.
I have not received germline genetic testing in the last two years.
I can speak and read English or Spanish.
I have not been diagnosed with dementia or cognitive impairment.
You may not be able to join if
I have stage 0 or in-situ colorectal cancer.
I have a known psychiatric disorder affecting my judgment.
I cannot explain genetic test results to my family.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 su…
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.
Trial Locations
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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 o…
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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