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Active, Not Recruiting

NCT Number: NCT04763915

Improving Care After Inherited Cancer Testing

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

About this study

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 among individuals with a P/LP variant in an inherited cancer gene.
  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Correlative Studies (Survey)

Other

Administer surveys

Correlative Studies (Interview)

Other

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

GeneSHARE

Behavioral

Access to GeneSHARE, a web-based toolkit which includes interactive and narrative components to enhance FC of genetic test results.

LivingLabReport

Behavioral

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.

Standard-of-care & Adaptive Intervention

Behavioral

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.

Access to Education Materials

Other

Receive access to VUS educational materials

Primary outcomes

  1. 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

  2. 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.

Sponsors and collaborators

Lead sponsor

Vanderbilt-Ingram Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)
  • University of South Florida

Registry information

Official study title

Improving Care After Inherited Cancer Testing (IMPACT) Study

Acronym: IMPACT

Important dates

Study start
2022
Primary completion
2027
Study completion
2028
First posted
Feb 21, 2021
Registry last updated
Sep 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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