Vanderbilt Clinical Trials

Improving Care After Inherited Cancer Testing

Purpose

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.

Conditions

Inherited Cancer Syndrome
Prostate Cancer
Colorectal Cancer
Endometrial Cancer
Breast Cancer

Eligibility

Eligible Ages: Over 18 Years
Eligible Genders: All
Accepts Healthy Volunteers: Yes

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

Study Design

Phase: N/A
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Prevention
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
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.
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.
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.
Experimental Variants of Uncertain Significance (VUS) Pilot Study	Participants are provided access to VUS educational resources including video and written education and assistance for speaking with family members.	Other: Correlative Studies (Survey) Administer surveys Other: Access to Education Materials Receive access to VUS educational materials

Recruiting Locations

Vanderbilt-Ingram Cancer Center
Nashville, Tennessee 37212

Contact:
Anne Weidner, MPH
615-875-2444

More Details

Status: Recruiting
Sponsor: Vanderbilt-Ingram Cancer Center

Study Contact

Anne Weidner, MPH
615-875-2444
IMPACT@vumc.org

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.