Improving Care After Inherited Cancer Testing (IMPACT)

Vanderbilt University Medical Center

Status: Active, not recruiting

Conditions: Endometrial Cancer; Breast Cancer; Prostate Cancer; Inherited Cancer Syndrome; Colorectal Cancer

Treatments: Behavioral: LivingLabReport; Behavioral: Standard-of-care & Adaptive Intervention; Other: Correlative Studies (Survey); Behavioral: GeneSHARE; Other: Access to Education Materials; Other: Correlative Studies (Interview)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04763915

VICC SUPP 2112

U01CA254832 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 720 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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720 participants in 4 patient groups

GeneSHARE

Experimental group

Description:

Access to GeneSHARE, a web-based toolkit including interactive and narrative components to enhance FC of genetic test results.

Treatment:

Other: Correlative Studies (Interview)

Behavioral: GeneSHARE

Other: Correlative Studies (Survey)

LivingLabReport

Experimental group

Description:

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.

Treatment:

Other: Correlative Studies (Interview)

Other: Correlative Studies (Survey)

Behavioral: LivingLabReport

Standard-of-care

Active Comparator group

Description:

Receive standard-of-care from their treating healthcare provider.

Treatment:

Other: Correlative Studies (Interview)

Other: Correlative Studies (Survey)

Behavioral: Standard-of-care & Adaptive Intervention

Variants of Uncertain Significance (VUS) Pilot Study

Experimental group

Description:

Participants are provided access to VUS educational resources including video and written education and assistance for speaking with family members.

Treatment:

Other: Access to Education Materials

Other: Correlative Studies (Survey)