Improving Care After Inherited Cancer Testing
Status
RECRUITING
Phase
NA
Age
≥ 18 Years
Enrollments
720Conditions
Inherited Cancer Syndrome, Prostate Cancer, Colorectal Cancer, Endometrial Cancer, Breast CancerSummary
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.
Locations
1 location Found with status Recruiting
Status
- RECRUITING
Contact Person
- Anne Weidner, MPH
- 615-875-2444
Principal Investigator
- Tuya Pal, MD
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
Study Plan
GeneSHARE
EXPERIMENTAL
Access to GeneSHARE, a web-based toolkit including interactive and narrative components to enhance FC of genetic test results.
OTHER:
Correlative Studies (Survey)Description:
Administer surveysOTHER:
Correlative Studies (Interview)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 interventionBEHAVIORAL:
GeneSHAREDescription:
Access to GeneSHARE, a web-based toolkit which includes interactive and narrative components to enhance FC of genetic test results.
LivingLabReport
EXPERIMENTAL
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)Description:
Administer surveysOTHER:
Correlative Studies (Interview)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 interventionBEHAVIORAL:
LivingLabReportDescription:
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
ACTIVE_COMPARATOR
Receive standard-of-care from their treating healthcare provider.
OTHER:
Correlative Studies (Survey)Description:
Administer surveysOTHER:
Correlative Studies (Interview)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 interventionBEHAVIORAL:
Standard-of-care & Adaptive InterventionDescription:
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.
Variants of Uncertain Significance (VUS) Pilot Study
EXPERIMENTAL
Participants are provided access to VUS educational resources including video and written education and assistance for speaking with family members.
OTHER:
Correlative Studies (Survey)Description:
Administer surveysOTHER:
Access to Education MaterialsDescription:
Receive access to VUS educational materials
Outcome Measures
Primary Outcome Measures
Change in FC of genetic test results (if P/LP variant result) or family history of cancer (if VUS result)
Change in CRM
Timeline
Last Updated
February 13, 2024Start Date
February 21, 2021Today
January 16, 2025Completion Date ( Estimated )
December 1, 2028
Sponsors of this trial
Lead Sponsor
Vanderbilt-Ingram Cancer CenterCollaborating Sponsors
National Cancer Institute (NCI), University of South Florida
RECRUITING 
21 - 64 Years