Improving Care After Inherited Cancer Testing

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.

Conditions

• Inherited Cancer Syndrome
• Prostate Cancer
• Colorectal Cancer
• Endometrial Cancer
• Breast Cancer

Interventions

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.

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.

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.

OTHER

Access to Education Materials

Receive access to VUS educational materials

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• University of South Florida

  collaborator OTHER

• Vanderbilt-Ingram Cancer Center

  lead OTHER

Principal Investigators

• Tuya Pal, MD · Vanderbilt-Ingram Cancer Center

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-08-05

Primary Completion

2027-12-31

Completion

2028-12-31

Countries

• United States

Study Locations