Breast Cancer, Colorectal Cancer, Endometrial Cancer, Inherited Cancer Syndrome, Prostate Cancer
Conditions
Keywords
Inherited Cancer Gene, Pathogenic/Likely Pathogenic Variant, Variant of Uncertain Significance, Cancer Risk Management, Family Sharing
Brief summary
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.
Detailed description
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.
Interventions
OTHERCorrelative Studies (Survey)
Administer surveys
OTHERCorrelative Studies (Interview)
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
BEHAVIORALGeneSHARE
Access to GeneSHARE, a web-based toolkit which includes interactive and narrative components to enhance FC of genetic test results.
BEHAVIORALLivingLabReport
Access to LivingLabReport, a website containing multiple resources including a summary of the patient's genetic test results, condition-specific information, recommended CRM, and information on accessing CRM services.
BEHAVIORALStandard-of-care & Adaptive Intervention
Receive standard-of-care from their treating healthcare provider. A subset of individuals will also be asked to test and pilot the adaptive intervention, which will consist of tailored resources to promote CRM and FC, after the 12-month follow-up survey.
OTHERAccess to Education Materials
Receive access to VUS educational materials
Sponsors
National Cancer Institute (NCI)
University of South Florida
Vanderbilt-Ingram Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in FC of genetic test results (if P/LP variant result) or family history of cancer (if VUS result) | 12 months | 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 |
| Change in CRM | 12 months | 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. |
Countries
United States
Outcome results
None listed