Improving Care After Inherited Cancer Testing (IMPACT)

September 15, 2025 updated by: Tuya Pal, Vanderbilt-Ingram Cancer Center

Improving Care After Inherited Cancer Testing (IMPACT) Study

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

720

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37212
        • Vanderbilt-Ingram Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in CRM
Time Frame: 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.
12 months
Change in FC of genetic test results (if P/LP variant result) or family history of cancer (if VUS result)
Time Frame: 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
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanderbilt-Ingram Cancer Center

Collaborators

National Cancer Institute (NCI)
University of South Florida

Investigators

  • Principal Investigator: Tuya Pal, MD, Vanderbilt-Ingram Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 5, 2022

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

February 15, 2021

First Submitted That Met QC Criteria

February 18, 2021

First Posted (Actual)

February 21, 2021

Study Record Updates

Last Update Posted (Estimated)

September 19, 2025

Last Update Submitted That Met QC Criteria

September 15, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VICC SUPP 2112
  • U01CA254832 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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