Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (15)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colon Adenocarcinoma | Colon Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Colorectal Adenocarcinoma | Colorectal Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Rectal Adenocarcinoma | Rectal Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Stage I Colon Cancer AJCC v8 | Malignant Colon Neoplasm | CURATED_BROADER | 0.78 |
| Stage I Colorectal Cancer AJCC v8 | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Stage II Colon Cancer AJCC v8 | Malignant Colon Neoplasm | CURATED_BROADER | 0.78 |
| Stage II Colorectal Cancer AJCC v8 | Malignant Colorectal Neoplasm | CURATED_BROADER |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biospecimen Collection | Procedure | — | UNRESOLVED |
| Communication Intervention | Other | — | UNRESOLVED |
| Genetic Testing | Other | — | UNRESOLVED |
| Survey Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Step 1 (biospecimen collection, genetic testing)
- description
- Probands undergo collection of blood samples and genetic testing on study.
- interventionNames
- Procedure: Biospecimen Collection
- Other: Genetic Testing
- type
- ACTIVE_COMPARATOR
- label
- Step 2, Arm A (proband-mediated)
- description
- FDRs receive proband-mediated communication about the proband's genetic testing results.
- interventionNames
- Other: Communication Intervention
- Other: Survey Administration
- type
- EXPERIMENTAL
- label
- Step 2, Arm B (provider-mediated)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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: \-
References
Publications (0)
Data not yet available