ACTIVE_NOT_RECRUITING

Improving Care After Inherited Cancer Testing

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Conditions

Inherited Cancer SyndromeProstate CancerColorectal CancerEndometrial CancerBreast CancerInherited Cancer GenePathogenic/Likely Pathogenic VariantVariant of Uncertain SignificanceCancer Risk ManagementFamily Sharing

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Improving Care After Inherited Cancer Testing (IMPACT) Study

Quick Facts

Study Start:2022-08-05
Study Completion:2028-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04763915

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * English-speaking men and women aged 18 years or older
  2. * Not adopted (i.e., have information about their biological relatives)
  3. * Have access to internet and a computer, tablet, or smartphone
  4. * 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
  5. * Must meet at least one of the following criteria:
  6. * Intervention A (GeneSHARE) criteria: Have at least one at-risk adult, living relative who either:
  7. * has not been told about the genetic test result by the participant
  8. * has not had their own genetic testing
  9. * 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
  10. * English-speaking men and women aged 18 years or older
  11. * Not adopted (i.e., have information about their biological relatives)
  12. * Have access to internet and a computer, tablet, or smartphone
  13. * Documented VUS in an inherited cancer gene
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Principal Investigator

Tuya Pal, MD
PRINCIPAL_INVESTIGATOR
Vanderbilt-Ingram Cancer Center

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Vanderbilt-Ingram Cancer Center

  • Tuya Pal, MD, PRINCIPAL_INVESTIGATOR, Vanderbilt-Ingram Cancer Center

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 Registration Dates

Study Start Date2022-08-05
Study Completion Date2028-12

Study Record Updates

Study Start Date2022-08-05
Study Completion Date2028-12

Terms related to this study

Keywords Provided by Researchers

  • Inherited Cancer Gene
  • Pathogenic/Likely Pathogenic Variant
  • Variant of Uncertain Significance
  • Cancer Risk Management
  • Family Sharing

Additional Relevant MeSH Terms

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