Family Communications After Genetic Testing | NCT07143487 | Trialant

Family Communications After Genetic Testing | NCT07143487 | Trialant

Official Title: Evaluation of Provider vs. Patient Mediated Cascade Genetic Testing of First-Degree Relatives of Patients With Newly Diagnosed Colorectal Cancer
Brief Summary: 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.
Detailed Description: PRIMARY OBJECTIVES:

I. To compare the proportion of first-degree relatives (FDRs) of probands with Lynch Syndrome who undergo germline testing in the provider-mediated arm (Arm B) versus the proband-mediated (Arm A) at 6 months.

II. To compare the proportion of FDRs of proband with a non-Lynch pathogenic germline variant who undergo germline testing in the provider-mediated arm (Arm B) versus the proband-mediated arm (Arm A) at 6 months.

SECONDARY OBJECTIVE:

I. To compare the proportion of FDRs with a pathogenic germline variant (PGV) who underwent disease prevention efforts at 12 months between the provider-mediated arm (Arm B) and the proband-mediated cascade testing arm (Arm A).

EXPLORATORY OBJECTIVES:

I. To assess differences in percentages of cascade genetic testing within the following proband subgroups: race/ethnicity (non-Hispanic whites; other race/ethnicities), sex (females; males), age (>= 50; < 50), tumor location (colon; rectal), tumor stage (stage I-II; stage III-IV), geographic location (urban; rural), and receipt of medical care in an academic versus (vs.) community setting.

III. To determine the prevalence and spectrum of pathogenic germline variants in cancer susceptibility genes by analysis of results of upfront germline testing in a multi-site cancer cooperative group study population with newly diagnosed CRC.

IV. Assess the pattern of accrual of demographic patient subgroups including racial/ethnic minority and rural individuals at the initial 50% of accrual enrolled and at the end of the trial.

V. To compare disease-free survival (DFS) of the proband at 3 years between the direct-contact arm (Arm B) and the proband-directed cascade testing arm (Arm A).

V. 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.

STEP 2: Probands with pathogenic or likely pathogenic germline variants and their FDRs are randomized to 1 of 2 arms.

ARM A: FDRs receive proband-mediated communication about the proband's genetic testing results.

ARM B: FDRs receive provider-mediated communication about the proband's genetic testing results.

Probands are followed for up to 3 years and FDRs are followed for up to 1 year

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: Yes
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:

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Anchorage Associates in Radiation MedicineRecruiting

Anchorage, Alaska 98508, United States

Site Public ContactContact

AKPAMC.OncologyResearchSupport@providence.org907-212-6871

Alison K. ConlinPrincipal Investigator

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Site Public ContactContact

kforman1@hfhs.org313-343-3166

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PeaceHealth Saint Joseph Medical CenterRecruiting

Bellingham, Washington 98225, United States

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Edmonds, Washington 98026, United States

Providence Regional Cancer PartnershipRecruiting

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Issaquah, Washington 98029, United States

Kadlec Clinic Hematology and OncologyRecruiting

Kennewick, Washington 99336, United States

Providence Regional Cancer System-LaceyRecruiting

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PeaceHealth Saint John Medical CenterRecruiting

Longview, Washington 98632, United States

Skagit Regional Health Cancer Care CenterRecruiting

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Swedish Medical Center-Cherry HillRecruiting

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PeaceHealth United General Medical CenterRecruiting

Sedro-Woolley, Washington 98284, United States

Saint Joseph Medical Center Hematology and Oncology - SilverdaleRecruiting

Silverdale, Washington 98383, United States

Cancer Care Northwest - Spokane SouthRecruiting

Spokane, Washington 99202, United States

Cancer Care Northwest-ValleyRecruiting

Spokane, Washington 99216, United States

Cancer Care Northwest-North SpokaneRecruiting

Spokane, Washington 99218, United States

PeaceHealth Southwest Medical CenterRecruiting

Vancouver, Washington 98664, United States

Providence Saint Mary Regional Cancer CenterRecruiting

Walla Walla, Washington 99362, United States

Duluth Clinic AshlandRecruiting

Ashland, Wisconsin 54806, United States

Northwest Wisconsin Cancer CenterRecruiting

Ashland, Wisconsin 54806, United States

Essentia Health-Hayward ClinicRecruiting

Hayward, Wisconsin 54843, United States

Tamarack Health Hayward Medical CenterRecruiting

Hayward, Wisconsin 54843, United States

Cancer Center of Western WisconsinRecruiting

New Richmond, Wisconsin 54017, United States

Essentia Health-Spooner ClinicRecruiting

Spooner, Wisconsin 54801, United States

Essentia Health Saint Mary's Hospital - SuperiorRecruiting

Superior, Wisconsin 54880, United States

Memorial Hospital of Laramie CountyRecruiting

Cheyenne, Wyoming 82001, United States

Billings Clinic-CodyRecruiting

Cody, Wyoming 82414, United States

Cancer Center-Metro Medical Center BayamonRecruiting

Bayamón, 00959-5060, Puerto Rico

Puerto Rico Hematology Oncology GroupRecruiting

Bayamón, 00961, Puerto Rico

Doctors Cancer CenterRecruiting

Manati, 00674, Puerto Rico

San Juan Community Oncology GroupRecruiting

San Juan, 00917, Puerto Rico

Centro Comprensivo de Cancer de UPRRecruiting

San Juan, 00927, Puerto Rico

PROncologyRecruiting

San Juan, 00927, Puerto Rico

San Juan City HospitalRecruiting

San Juan, 00936, Puerto Rico