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Improving Care After Inherited Cancer Testing (IMPACT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04763915
Recruitment Status : Recruiting
First Posted : February 21, 2021
Last Update Posted : March 2, 2022
Sponsor:
Collaborators:
National Cancer Institute (NCI)
University of South Florida
Information provided by (Responsible Party):
Tuya Pal, Vanderbilt-Ingram Cancer Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Inherited Cancer Syndrome Prostate Cancer Colorectal Cancer Endometrial Cancer Breast Cancer Other: Correlative Studies (Survey) Other: Correlative Studies (Interview) Behavioral: GeneSHARE Behavioral: LivingLabReport Behavioral: Standard-of-care & Adaptive Intervention Not Applicable

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
  3. Create and pilot an adaptive intervention to tailor resources to promote CRM and FC
  4. Document and compare multiple implementation outcomes across the different interventions to maximize their effectiveness and improve reach to underserved populations
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 720 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Improving Care After Inherited Cancer Testing (IMPACT) Study
Estimated Study Start Date : April 2022
Estimated Primary Completion Date : December 2027
Estimated Study Completion Date : December 2028
Arms and Interventions
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Arm Intervention/treatment
Experimental: GeneSHARE
Access to GeneSHARE, a web-based toolkit including interactive and narrative components to enhance FC of genetic test results.
 Other: Correlative Studies (Survey)
Administer surveys

Other: Correlative Studies (Interview)
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

Behavioral: GeneSHARE
Access to GeneSHARE, a web-based toolkit which includes interactive and narrative components to enhance FC of genetic test results.
Experimental: 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.
 Other: Correlative Studies (Survey)
Administer surveys

Other: Correlative Studies (Interview)
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

Behavioral: 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.
Active Comparator: Standard-of-care
Receive standard-of-care from their treating healthcare provider.
 Other: Correlative Studies (Survey)
Administer surveys

Other: Correlative Studies (Interview)
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

Behavioral: Standard-of-care & Adaptive Intervention
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.


Outcome Measures
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Primary Outcome Measures :
  1. Change in FC of genetic test results (if P/LP variant result) or family history of cancer (if VUS result) [ Time Frame: 12 months ]
    Having at least one additional at-risk, adult, living relative who has either been told about the test result or family history of cancer by the participant or has undergone genetic testing of their own.

  2. Change in CRM [ Time Frame: 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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04763915


Contacts
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Contact: Anne Weidner, MPH 615-875-2444 IMPACT@vumc.org

Locations
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United States, Tennessee
Vanderbilt-Ingram Cancer Center Recruiting
Nashville, Tennessee, United States, 37212
Contact: Anne Weidner, MPH    615-875-2444      
Principal Investigator: Tuya Pal, MD         
Sponsors and Collaborators
Vanderbilt-Ingram Cancer Center
National Cancer Institute (NCI)
University of South Florida
Investigators
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Principal Investigator: Tuya Pal, MD Vanderbilt-Ingram Cancer Center
  Study Documents (Full-Text)

Documents provided by Tuya Pal, Vanderbilt-Ingram Cancer Center:
Informed Consent Form  [PDF] November 18, 2020

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Tuya Pal, Associate Director for Cancer Health Disparities, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier: NCT04763915    
Other Study ID Numbers: VICC SUPP 2112
U01CA254832 ( U.S. NIH Grant/Contract )
First Posted: February 21, 2021    Key Record Dates
Last Update Posted: March 2, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tuya Pal, Vanderbilt-Ingram Cancer Center:
Inherited Cancer Gene
Pathogenic/Likely Pathogenic Variant
Variant of Uncertain Significance
Cancer Risk Management
Family Sharing
Additional relevant MeSH terms:
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Endometrial Neoplasms
Neoplastic Syndromes, Hereditary
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
 Uterine Neoplasms
Genital Neoplasms, Female
Uterine Diseases
Genetic Diseases, Inborn