Clinical trial NCT04763915: Improving Care After Inherited Cancer Testing
Official title: Improving Care After Inherited Cancer Testing (IMPACT) Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Inherited Cancer Syndrome
Prostate Cancer
Colorectal Cancer
Endometrial Cancer
Breast Cancer
Keywords: Inherited Cancer Gene
Pathogenic/Likely Pathogenic Variant
Variant of Uncertain Significance
Cancer Risk Management
Family Sharing
Lead sponsor: Vanderbilt-Ingram Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: University of South Florida
First posted: 2021-02-21
Enrollment: 720
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 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.

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 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.

Eligibility 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

Primary outcomes:
measure: Change in FC of genetic test results (if P/LP variant result) or family history of cancer (if VUS result)
timeFrame: 12 months
measure: Change in CRM
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center
state: Tennessee
Study officials:
affiliation: Vanderbilt-Ingram Cancer Center
name: Tuya Pal, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cragun D, Beckstead J, Farmer M, Hooker G, Dean M, Matloff E, Reid S, Tezak A, Weidner A, Whisenant JG, Pal T. IMProving care After inherited Cancer Testing (IMPACT) study: protocol of a randomized trial evaluating the efficacy of two interventions designed to improve cancer risk management and family communication of genetic test results. BMC Cancer. 2021 Oct 13;21(1):1099. doi: 10.1186/s12885-021-08822-4.