IMPACT: Improving Care After Inherited Cancer Testing
Study Details
Study Description
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. These interventions will be delivered to individuals with a documented pathogenic/likely pathogenic (P/LP) variant or variant of uncertain significance (VUS) in an inherited cancer gene.
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
Detailed Description
Through recruitment of a racially, geographically, and socioeconomically diverse sample of patients, we will achieve the following aims:
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Evaluate factors associated with access to genetic risk assessment, counseling, and testing services
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Conduct a randomized controlled trial to assess the effectiveness of interventions on improving guideline-adherent CRM and FC of genetic test results
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Create and pilot an adaptive intervention to tailor resources to promote CRM and FC
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Document and compare multiple implementation outcomes across the different interventions to maximize their effectiveness and improve reach to underserved populations
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: GeneSHARE Access to GeneSHARE, a web-based toolkit including interactive and narrative components to enhance FC of genetic test results. |
Other: Correlative Studies (Survey)
Administer surveys
Other: Correlative 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
Behavioral: GeneSHARE
Access to GeneSHARE, a web-based toolkit which includes interactive and narrative components to enhance FC of genetic test results.
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Experimental: LivingLabReport 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. |
Other: Correlative Studies (Survey)
Administer surveys
Other: Correlative 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
Behavioral: LivingLabReport
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.
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Active Comparator: Standard-of-care Receive standard-of-care from their treating healthcare provider. |
Other: Correlative Studies (Survey)
Administer surveys
Other: Correlative 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
Behavioral: Standard-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.
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Outcome Measures
Primary Outcome Measures
- 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 who has either been told about the test result or family history of cancer by the participant or has undergone genetic testing of their own.
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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English-speaking
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Not adopted (i.e., have information about their biological relatives)
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Have an email address with access to internet and a computer, tablet, or smartphone
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Documented pathogenic/likely pathogenic variant or VUS 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
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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
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Have at least one at-risk adult, living relative who either:
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has not been told about the genetic test result (if P/LP variant result) or family history of cancer (if VUS result) by the participant
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has not had their own genetic testing if the participant has a pathogenic/likely pathogenic variant
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Vanderbilt-Ingram Cancer Center | Nashville | Tennessee | United States | 37212 |
Sponsors and Collaborators
- Vanderbilt-Ingram Cancer Center
- National Cancer Institute (NCI)
- University of South Florida
Investigators
- Principal Investigator: Tuya Pal, MD, Vanderbilt-Ingram Cancer Center
Study Documents (Full-Text)
More Information
Publications
None provided.- VICC SUPP 2112
- U01CA254832