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Genetic Counseling Interventions for Cancer Risk Management (IMPACT Trial)
N/A
Recruiting
Led By Tuya Pal, MD
Research Sponsored by Vanderbilt-Ingram Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Must have a 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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
IMPACT Trial Summary
This trial is testing whether interventions can improve cancer risk management and communication with family members after getting genetic test results.
Who is the study for?
This trial is for individuals who are not following current cancer screening guidelines or need ongoing screening, know their biological family history, speak English, have internet access and a device. They must have certain genetic variations linked to cancer and at least one relative unaware of these risks.Check my eligibility
What is being tested?
The IMPACT Study tests interventions like surveys, interviews, GeneSHARE program, LivingLabReport tool against standard care to see if they improve adherence to cancer risk management guidelines and communication about genetic test results within families.See study design
What are the potential side effects?
Since the study involves non-medical interventions such as surveys and educational tools rather than drugs or medical procedures, traditional side effects are not expected. Participants may experience discomfort discussing personal health information.
IMPACT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a genetic mutation linked to cancer, as per NCCN guidelines.
IMPACT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in CRM
Change in FC of genetic test results (if P/LP variant result) or family history of cancer (if VUS result)
IMPACT Trial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: Variants of Uncertain Significance (VUS) Pilot StudyExperimental Treatment2 Interventions
Participants are provided access to VUS educational resources including video and written education and assistance for speaking with family members.
Group II: LivingLabReportExperimental Treatment3 Interventions
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.
Group III: GeneSHAREExperimental Treatment3 Interventions
Access to GeneSHARE, a web-based toolkit including interactive and narrative components to enhance FC of genetic test results.
Group IV: Standard-of-careActive Control3 Interventions
Receive standard-of-care from their treating healthcare provider.
Find a Location
Who is running the clinical trial?
Vanderbilt-Ingram Cancer CenterLead Sponsor
213 Previous Clinical Trials
60,213 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,665 Previous Clinical Trials
40,925,045 Total Patients Enrolled
University of South FloridaOTHER
412 Previous Clinical Trials
186,339 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a relative at risk who hasn't been informed about my genetic test results or our family's cancer history.I have a genetic mutation linked to cancer, as per NCCN guidelines.I am not following one of the cancer treatment guidelines or need ongoing cancer screening.You cannot be adopted or have no information about your biological relatives.
Research Study Groups:
This trial has the following groups:- Group 1: Variants of Uncertain Significance (VUS) Pilot Study
- Group 2: GeneSHARE
- Group 3: LivingLabReport
- Group 4: Standard-of-care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any predetermined parameters for enrolling subjects in this clinical experiment?
"Affirmative, clinicaltrials.gov's records demonstrate that this study is open for recruitment at present. It was initially posted on August 5th 2022 and has been most recently updated on October 3rd 2022. This trial requires 720 patients to be enrolled in a single site."
Answered by AI
Are there any available spots to join this research study?
"Per records on clinicaltrials.gov, this trial is currently recruiting participants as of October 3rd 2022; it was initially unveiled on August 5th 2022."
Answered by AI
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