IMPACT: Improving Care After Inherited Cancer Testing

Sponsor
Vanderbilt-Ingram Cancer Center (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04763915
Collaborator
National Cancer Institute (NCI) (NIH), University of South Florida (Other)
720
Enrollment
1
Location
3
Arms
84
Anticipated Duration (Months)
8.6
Patients Per Site Per Month

Study Details

Study Description

Brief 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. These interventions will be delivered to individuals with a documented pathogenic/likely pathogenic (P/LP) variant or variant of uncertain significance (VUS) in an inherited cancer gene.

Condition or DiseaseIntervention/TreatmentPhase
  • Other: Correlative Studies (Survey)
  • Other: Correlative Studies (Interview)
  • Behavioral: GeneSHARE
  • Behavioral: LivingLabReport
  • Behavioral: Standard-of-care & Adaptive Intervention
N/A

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

  3. Create and pilot an adaptive intervention to tailor resources to promote CRM and FC

  4. Document and compare multiple implementation outcomes across the different interventions to maximize their effectiveness and improve reach to underserved populations

Study Design

Study Type:
Interventional
Anticipated Enrollment :
720 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Improving Care After Inherited Cancer Testing (IMPACT) Study
Anticipated Study Start Date :
Dec 1, 2021
Anticipated Primary Completion Date :
Dec 1, 2027
Anticipated Study Completion Date :
Dec 1, 2028

Arms and Interventions

ArmIntervention/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.

Outcome Measures

Primary Outcome Measures

  1. Change in FC of genetic test results (if P/LP variant result) or family history of cancer (if VUS result) [12 months]

    Having at least one additional at-risk, adult, living relative who has either been told about the test result or family history of cancer by the participant or has undergone genetic testing of their own.

  2. Change in CRM [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • English-speaking

  • Not adopted (i.e., have information about their biological relatives)

  • Have an email address with access to internet and a computer, tablet, or smartphone

  • Documented pathogenic/likely pathogenic variant or VUS 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

  • 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

  • Have at least one at-risk adult, living relative who either:

  • has not been told about the genetic test result (if P/LP variant result) or family history of cancer (if VUS result) by the participant

  • has not had their own genetic testing if the participant has a pathogenic/likely pathogenic variant

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Vanderbilt-Ingram Cancer CenterNashvilleTennesseeUnited States37212

Sponsors and Collaborators

  • Vanderbilt-Ingram Cancer Center
  • National Cancer Institute (NCI)
  • University of South Florida

Investigators

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

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Tuya Pal, Associate Director for Cancer Health Disparities, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier:
NCT04763915
Other Study ID Numbers:
  • VICC SUPP 2112
  • U01CA254832
First Posted:
Feb 21, 2021
Last Update Posted:
Nov 17, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Tuya Pal, Associate Director for Cancer Health Disparities, Vanderbilt-Ingram Cancer Center
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 17, 2021