Improving cancer risk management and family communication after genetic testing
Improving Care After Inherited Cancer Testing (IMPACT) Study
This study is testing ways to help people with inherited cancer gene variants better manage their cancer risk and communicate important genetic test results with their families.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 720 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Vanderbilt-Ingram Cancer Center Academic / other |
| Locations | 1 site (Nashville, Tennessee) |
| Trial ID | NCT04763915 on ClinicalTrials.gov |
What this trial studies
The IMPACT Study aims to enhance cancer risk management and family communication regarding genetic test results for individuals with inherited cancer gene variants. It involves a randomized controlled trial to evaluate interventions that promote adherence to cancer risk management guidelines and improve communication about family cancer history. The study will recruit a diverse group of participants and assess various factors influencing access to genetic services. Additionally, it will pilot adaptive interventions tailored to individual needs to maximize effectiveness, particularly for underserved populations.
Who should consider this trial
Good fit: Ideal candidates include English-speaking adults aged 18 and older with a documented pathogenic or likely pathogenic variant in an inherited cancer gene.
Not a fit: Patients who are adopted and lack information about their biological relatives may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved cancer risk management and better communication of genetic information among families, ultimately enhancing patient outcomes.
How similar studies have performed: Other studies have shown success in improving genetic counseling and risk management, indicating that this approach has potential based on previous findings.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Nashville, Tennessee
- Vanderbilt-Ingram Cancer Center — Nashville, Tennessee, United States (Recruiting)
Study contacts
- Principal investigator: Tuya Pal, MD — Vanderbilt-Ingram Cancer Center
- Study coordinator: Anne Weidner, MPH
- Email: IMPACT@vumc.org
- Phone: 615-875-2444
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.