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Improving Care After Inherited Cancer Testing (IMPACT)

Primary Purpose

Inherited Cancer Syndrome, Prostate Cancer, Colorectal Cancer

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Correlative Studies (Survey)

Correlative Studies (Interview)

GeneSHARE

LivingLabReport

Standard-of-care & Adaptive Intervention

About this trial

This is an interventional prevention trial for Inherited Cancer Syndrome focused on measuring Inherited Cancer Gene, Pathogenic/Likely Pathogenic Variant, Variant of Uncertain Significance, Cancer Risk Management, Family Sharing

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

English-speaking
Not adopted (i.e., have information about their biological relatives)
Have an email address with access to internet and a computer, tablet, or smartphone
Documented pathogenic/likely pathogenic variant or VUS 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
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
Have at least one at-risk adult, living relative who either:
- has not been told about the genetic test result (if P/LP variant result) or family history of cancer (if VUS result) by the participant
- has not had their own genetic testing if the participant has a pathogenic/likely pathogenic variant

Sites / Locations

Vanderbilt-Ingram Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

GeneSHARE

LivingLabReport

Standard-of-care

Arm Description

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

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.

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

Outcomes

Primary Outcome Measures

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

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT04763915

First Posted

February 15, 2021

Last Updated

August 30, 2023

Sponsor

Vanderbilt-Ingram Cancer Center

Collaborators

National Cancer Institute (NCI), University of South Florida

1. Study Identification

Unique Protocol Identification Number

NCT04763915

Brief Title

Improving Care After Inherited Cancer Testing

Acronym

IMPACT

Official Title

Improving Care After Inherited Cancer Testing (IMPACT) Study

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Recruiting

Study Start Date

August 5, 2022 (Actual)

Primary Completion Date

December 2027 (Anticipated)

Study Completion Date

December 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Vanderbilt-Ingram Cancer Center

Collaborators

National Cancer Institute (NCI), University of South Florida

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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. These interventions will be delivered to individuals with a documented pathogenic/likely pathogenic (P/LP) variant or 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: Evaluate factors associated with access to genetic risk assessment, counseling, and testing services Conduct a randomized controlled trial to assess the effectiveness of interventions on improving guideline-adherent CRM and FC of genetic test results Create and pilot an adaptive intervention to tailor resources to promote CRM and FC Document and compare multiple implementation outcomes across the different interventions to maximize their effectiveness and improve reach to underserved populations

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

720 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

GeneSHARE

Arm Type

Experimental

Arm Description

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

Arm Title

LivingLabReport

Arm Type

Experimental

Arm Description

Arm Title

Standard-of-care

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Correlative Studies (Survey)

Intervention Description

Administer surveys

Intervention Type

Other

Intervention Name(s)

Correlative Studies (Interview)

Intervention Description

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

Intervention Type

Behavioral

Intervention Name(s)

GeneSHARE

Intervention Description

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

Intervention Type

Behavioral

Intervention Name(s)

LivingLabReport

Intervention Description

Intervention Type

Behavioral

Intervention Name(s)

Standard-of-care & Adaptive Intervention

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in FC of genetic test results (if P/LP variant result) or family history of cancer (if VUS result)

Description

Time Frame

12 months

Title

Change in CRM

Description

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: English-speaking 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 or VUS 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 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 (if P/LP variant result) or family history of cancer (if VUS result) by the participant has not had their own genetic testing if the participant has a P/LP variant 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Anne Weidner, MPH

Phone

615-875-2444

IMPACT@vumc.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tuya Pal, MD

Organizational Affiliation

Vanderbilt-Ingram Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Vanderbilt-Ingram Cancer Center

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37212

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Anne Weidner, MPH

Phone

615-875-2444

First Name & Middle Initial & Last Name & Degree

Tuya Pal, MD

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

34645413

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.

Results Reference

derived

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Improving Care After Inherited Cancer Testing

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