Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
NA
720 participants
INTERVENTIONAL
2022-08-05
2028-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Developing New Educational Materials About Genetic Testing for a Diverse Group of Cancer Patients
NCT04751435
Genetic Epidemiology Risk Assessment Program or Usual Care in Colorectal Cancer Screening for Healthy Participants
NCT00478309
Family Communications After Genetic Testing
NCT07143487
Colorectal Cancer Screening Intervention for Family Members of Colorectal Cancer Patients
NCT00582829
Genetic and Environmental Risk Assessment for Colorectal Cancer in Healthy Participants
NCT00087360
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
GeneSHARE
Access to GeneSHARE, a web-based toolkit including interactive and narrative components to enhance FC of genetic test results.
Correlative Studies (Survey)
Administer surveys
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
GeneSHARE
Access to GeneSHARE, a web-based toolkit which includes interactive and narrative components to enhance FC of genetic test results.
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.
Correlative Studies (Survey)
Administer surveys
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
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.
Standard-of-care
Receive standard-of-care from their treating healthcare provider.
Correlative Studies (Survey)
Administer surveys
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
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.
Variants of Uncertain Significance (VUS) Pilot Study
Participants are provided access to VUS educational resources including video and written education and assistance for speaking with family members.
Correlative Studies (Survey)
Administer surveys
Access to Education Materials
Receive access to VUS educational materials
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Correlative Studies (Survey)
Administer surveys
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
GeneSHARE
Access to GeneSHARE, a web-based toolkit which includes interactive and narrative components to enhance FC of genetic test results.
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.
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.
Access to Education Materials
Receive access to VUS educational materials
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Cancer Institute (NCI)
NIH
University of South Florida
OTHER
Vanderbilt-Ingram Cancer Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Tuya Pal
Associate Director for Cancer Health Disparities
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Tuya Pal, MD
Role: PRINCIPAL_INVESTIGATOR
Vanderbilt-Ingram Cancer Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Informed Consent Form
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
VICC SUPP 2112
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.