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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

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have a genetic mutation linked to cancer, as per NCCN guidelines.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in CRM

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 1Eligibility criteria met