Improving Care After Inherited Cancer Testing

N/AActive Not RecruitingNCT04763915

Vanderbilt-Ingram Cancer Center720 enrolled

Overview

The IMPACT Study seeks to refine and evaluate the effectiveness of interventions on improving guideline-adherent cancer risk management (CRM) and family communication (FC) of genetic test results for individuals with a documented pathogenic/likely pathogenic (P/LP) variant, and FC of family cancer history for individuals with a variant of uncertain significance (VUS) in an inherited cancer gene.

Through recruitment of a racially, geographically, and socioeconomically diverse sample of patients, we will achieve the following aims: 1. Evaluate factors associated with access to genetic risk assessment, counseling, and testing services. 2. Conduct a randomized controlled trial to assess the effectiveness of interventions on improving guideline-adherent CRM and FC of genetic test results among individuals with a P/LP variant in an inherited cancer gene. 3. Conduct a pilot study to assess the effectiveness of an intervention on improving FC of family cancer history among individuals with a VUS in an inherited cancer gene. 4. Create and pilot an adaptive intervention to tailor resources to promote CRM and FC. 5. Document and compare multiple implementation outcomes across the different interventions to maximize their effectiveness and improve reach to underserved populations.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

720

Conditions

Inherited Cancer Syndrome Prostate Cancer Colorectal Cancer Endometrial Cancer Breast Cancer

Interventions

Correlative Studies (Survey)OTHER

Administer surveys

Correlative Studies (Interview)OTHER

In-depth interviews among a subset of participants after the 12-month follow-up survey to either: 1) determine additional resources and tailored message that would be helpful; or 2) assess the adaptive intervention

GeneSHAREBEHAVIORAL

Access to GeneSHARE, a web-based toolkit which includes interactive and narrative components to enhance FC of genetic test results.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Randomized Controlled Trial Eligibility: All trial participants will be autonomous adults who are capable of participating in the study Inclusion Criteria: * English-speaking men and women aged 18 years or older * Not adopted (i.e., have information about their biological relatives) * Have access to internet and a computer, tablet, or smartphone * Documented pathogenic/likely pathogenic variant in an inherited cancer gene that has CRM guidelines listed in the National Comprehensive Cancer Network (NCCN) Genetic/Familial Panel focused on Breast, Ovarian, and Pancreatic or Colorectal cancers * Must meet at least one of the following criteria: * Intervention A (GeneSHARE) criteria: Have at least one at-risk adult, living relative who either: * has not been told about the genetic test result by the participant * has not had their own genetic testing * Intervention B (LivingLabReport) criteria: Are non-adherent (i.e., either undertreatment or overtreatment) to at least one of the current NCCN CRM guidelines or if currently adherent, require ongoing cancer screening VUS Pilot Study Eligibility: All VUS pilot study participants will be autonomous adults who are capable of participating in the study. Eligibility criteria include: * English-speaking men and women aged 18 years or older * Not adopted (i.e., have information about their biological relatives) * Have access to internet and a computer, tablet, or smartphone * Documented VUS in an inherited cancer gene

Locations (1)

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, United States

Outcomes

Primary Outcomes

Change in FC of genetic test results (if P/LP variant result) or family history of cancer (if VUS result)

Having at least one additional at-risk adult, living relative with whom the participant has shared their test result, information about testing, or family history of cancer for the first time or has subsequently followed up with a relative

Time frame: 12 months

Change in CRM

Ongoing guideline-adherent CRM or a change towards guideline-adherent CRM per National Comprehensive Cancer Network (NCCN) CRM guidelines based on genetic test results as measured by survey data and verified through medical records where possible and/or appropriate.

Time frame: 12 months

Data from ClinicalTrials.gov

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