Family Communications After Genetic Testing
Recruiting · NCT07143487 · Interventional (participants receive a specific treatment) · Lead sponsor: Alliance for Clinical Trials in Oncology
View the official record on ClinicalTrials.gov →Interventions studied
Biospecimen CollectionCommunication InterventionGenetic TestingSurvey Administration
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
60 locations listed across 28 US states.
- Anchorage Associates in Radiation Medicine - Anchorage, Alaska, United States
- Alaska Breast Care and Surgery LLC - Anchorage, Alaska, United States
- Alaska Oncology and Hematology LLC - Anchorage, Alaska, United States
- Alaska Women's Cancer Care - Anchorage, Alaska, United States
- Katmai Oncology Group - Anchorage, Alaska, United States
- Providence Alaska Medical Center - Anchorage, Alaska, United States
- Fairbanks Memorial Hospital - Fairbanks, Alaska, United States
- Cancer Center at Saint Joseph's - Phoenix, Arizona, United States
- Mercy Hospital Fort Smith - Fort Smith, Arkansas, United States
- CARTI Cancer Center - Little Rock, Arkansas, United States
- Mission Hope Medical Oncology - Arroyo Grande - Arroyo Grande, California, United States
- Providence Saint Joseph Medical Center/Disney Family Cancer Center - Burbank, California, United States
- Mercy Cancer Center - Carmichael - Carmichael, California, United States
- Mercy San Juan Medical Center - Carmichael, California, United States
- Mercy Cancer Center - Elk Grove - Elk Grove, California, United States
- Mercy Cancer Center - Merced, California, United States
- Providence Queen of The Valley - Napa, California, United States
- Mercy Cancer Center - Rocklin - Rocklin, California, United States
- Mercy Cancer Center - Sacramento - Sacramento, California, United States
- Pacific Central Coast Health Center-San Luis Obispo - San Luis Obispo, California, United States
- Mission Hope Medical Oncology - Santa Maria - Santa Maria, California, United States
- Providence Medical Foundation - Santa Rosa - Santa Rosa, California, United States
- Providence Santa Rosa Memorial Hospital - Santa Rosa, California, United States
- Saint Helena Hospital - St. Helena, California, United States
- Saint Joseph's Medical Center - Stockton, California, United States
- Woodland Memorial Hospital - Woodland, California, United States
- Penrose-Saint Francis Healthcare - Colorado Springs, Colorado, United States
- Rocky Mountain Cancer Centers-Penrose - Colorado Springs, Colorado, United States
- Saint Francis Cancer Center - Colorado Springs, Colorado, United States
- CommonSpirit Cancer Center Mercy - Durango, Colorado, United States
- Mercy Medical Center - Durango, Colorado, United States
- CommonSpirit Saint Anthony Hospital Cancer Center - Lakewood, Colorado, United States
- Longmont United Hospital - Longmont, Colorado, United States
- Saint Mary Corwin Medical Center - Pueblo, Colorado, United States
- Saint Anthony North Hospital - Westminster, Colorado, United States
- Holy Cross Hospital - Fort Lauderdale, Florida, United States
- Saint Alphonsus Cancer Care Center-Boise - Boise, Idaho, United States
- Saint Luke's Cancer Institute - Boise - Boise, Idaho, United States
- Saint Alphonsus Cancer Care Center-Caldwell - Caldwell, Idaho, United States
- Kootenai Health - Coeur d'Alene - Coeur d'Alene, Idaho, United States
- Saint Luke's Cancer Institute - Fruitland - Fruitland, Idaho, United States
- Idaho Urologic Institute-Meridian - Meridian, Idaho, United States
- Saint Luke's Cancer Institute - Meridian - Meridian, Idaho, United States
- Saint Alphonsus Cancer Care Center-Nampa - Nampa, Idaho, United States
- Saint Luke's Cancer Institute - Nampa - Nampa, Idaho, United States
- Kootenai Clinic Cancer Services - Post Falls - Post Falls, Idaho, United States
- Kootenai Clinic Cancer Services - Sandpoint - Sandpoint, Idaho, United States
- Saint Luke's Cancer Institute - Twin Falls - Twin Falls, Idaho, United States
- OSF Saint Anthony's Health Center - Alton, Illinois, United States
- Illinois CancerCare-Bloomington - Bloomington, Illinois, United States
- Illinois CancerCare-Canton - Canton, Illinois, United States
- Memorial Hospital of Carbondale - Carbondale, Illinois, United States
- SIH Cancer Institute - Carterville, Illinois, United States
- Illinois CancerCare-Carthage - Carthage, Illinois, United States
- Centralia Oncology Clinic - Centralia, Illinois, United States
- Carle at The Riverfront - Danville, Illinois, United States
- Cancer Care Specialists of Illinois - Decatur - Decatur, Illinois, United States
- Decatur Memorial Hospital - Decatur, Illinois, United States
- Illinois CancerCare-Dixon - Dixon, Illinois, United States
- Carle Physician Group-Effingham - Effingham, Illinois, United States
Showing 60 of 299 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →