Improving Care After Inherited Cancer Testing

Study Overview
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Brief Summary
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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.

Detailed Description
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Through recruitment of a racially, geographically, and socioeconomically diverse sample of patients, we will achieve the following aims: Evaluate factors associated with access to genetic risk assessment, counseling, and testing services Conduct a randomized controlled trial to assess the effectiveness of interventions on improving guideline-adherent CRM and FC of genetic test results Create and pilot an adaptive intervention to tailor resources to promote CRM and FC Document and compare multiple implementation outcomes across the different interventions to maximize their effectiveness and improve reach to underserved populations

Official Title
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Improving Care After Inherited Cancer Testing (IMPACT) Study

Conditions
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Inherited Cancer Syndrome, Prostate Cancer, Colorectal Cancer, Endometrial Cancer, Breast Cancer

Intervention / Treatment
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* Other: Correlative Studies (Survey)
* Other: Correlative Studies (Interview)
* Behavioral: GeneSHARE
* Behavioral: LivingLabReport
* Behavioral: Standard-of-care & Adaptive Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: English-speaking 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 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 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 (if P/LP variant result) or family history of cancer (if VUS result) by the participant has not had their own genetic testing if the participant has a P/LP variant 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GeneSHARE<br>Access to GeneSHARE, a web-based toolkit including interactive and narrative components to enhance FC of genetic test results. | Other: Correlative Studies (Survey)<br>* Administer surveys<br>Other: Correlative Studies (Interview)<br>* 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<br>Behavioral: GeneSHARE<br>* Access to GeneSHARE, a web-based toolkit which includes interactive and narrative components to enhance FC of genetic test results.<br>|
| Experimental: LivingLabReport<br>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)<br>* Administer surveys<br>Other: Correlative Studies (Interview)<br>* 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<br>Behavioral: LivingLabReport<br>* 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.<br>|
| Active Comparator: Standard-of-care<br>Receive standard-of-care from their treating healthcare provider. | Other: Correlative Studies (Survey)<br>* Administer surveys<br>Other: Correlative Studies (Interview)<br>* 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<br>Behavioral: Standard-of-care & Adaptive Intervention<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Inherited Cancer Gene, Pathogenic/Likely Pathogenic Variant, Variant of Uncertain Significance, Cancer Risk Management, Family Sharing