Improving Care After Inherited Cancer Testing

Breast Cancer Clinical Trial

— IMPACT  

Official title:

Improving Care After Inherited Cancer Testing (IMPACT) Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04763915
• Other study ID #: VICC SUPP 2112
• Secondary ID: U01CA254832
• Status: Recruiting
• Phase: N/A
• Start date: August 5, 2022
• Est. completion date: December 2028

Study information

• Verified date: February 2024
• Source: Vanderbilt-Ingram Cancer Center
• Contact: Anne Weidner, MPH
• Phone: 615-875-2444
• Email: IMPACT[@]vumc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 720
• Est. completion date: December 2028
• Est. primary completion date: December 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Colorectal Cancer
• Endometrial Cancer
• Endometrial Neoplasms
• Inherited Cancer Syndrome
• Neoplastic Syndromes, Hereditary
• Prostate Cancer

Intervention

Other:
• Correlative Studies (Survey)
Administer surveys
• 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.
• 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.
• 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

Locations

Country	Name	City	State
United States	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee

Sponsors (3)

Lead Sponsor	Collaborator
Vanderbilt-Ingram Cancer Center	National Cancer Institute (NCI), University of South Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in FC of genetic test results (if P/LP variant result) or family history of cancer (if VUS result)	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
Primary	Change in CRM	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