Improving Care After Inherited Cancer Testing

Not Applicable

Recruiting

• Conditions: Inherited Cancer Syndrome; Prostate Cancer; Endometrial Cancer; Colorectal Cancer; Breast Cancer
• Interventions: Other: Correlative Studies (Survey); Other: Correlative Studies (Interview); Other: Access to Education Materials; Behavioral: Standard-of-care & Adaptive Intervention; Behavioral: GeneSHARE; Behavioral: LivingLabReport

• Registration Number: NCT04763915
• Lead Sponsor: Vanderbilt-Ingram Cancer Center

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.

Study Timeline

• Study First Submitted: 2021-02-15
• Study First Submitted QC: 2021-02-18
• Study First Posted: 2021-02-21
• Study Start: 2022-08-05
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-31
• Last Update Posted: 2025-04-01
• Primary Completion: 2027-12
• Study Completion: 2028-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 720

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GeneSHARE	Correlative Studies (Interview)	Access to GeneSHARE, a web-based toolkit including interactive and narrative components to enhance FC of genetic test results.
LivingLabReport	Correlative Studies (Survey)	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	Correlative Studies (Survey)	Receive standard-of-care from their treating healthcare provider.
Standard-of-care	Correlative Studies (Interview)	Receive standard-of-care from their treating healthcare provider.
Standard-of-care	Standard-of-care & Adaptive Intervention	Receive standard-of-care from their treating healthcare provider.
GeneSHARE	Correlative Studies (Survey)	Access to GeneSHARE, a web-based toolkit including interactive and narrative components to enhance FC of genetic test results.
GeneSHARE	GeneSHARE	Access to GeneSHARE, a web-based toolkit including interactive and narrative components to enhance FC of genetic test results.
LivingLabReport	Correlative Studies (Interview)	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.
Variants of Uncertain Significance (VUS) Pilot Study	Correlative Studies (Survey)	Participants are provided access to VUS educational resources including video and written education and assistance for speaking with family members.
LivingLabReport	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.
Variants of Uncertain Significance (VUS) Pilot Study	Access to Education Materials	Participants are provided access to VUS educational resources including video and written education and assistance for speaking with family members.

Primary Outcome Measures

Name	Time	Method
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.
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 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

Trial Locations

Locations (1)

Vanderbilt-Ingram Cancer Center; 🇺🇸 Nashville, Tennessee, United States