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NCT06284330 | RECRUITING | Hereditary Cancer

CHARGE Study: CHoice ARchitecture Genetic tEsting
Sponsor:

University of Texas Southwestern Medical Center

Information provided by (Responsible Party):

Happiness

Brief Summary:

CHARGE is a hybrid type I feasibility study to compare a choice architecture intervention for cascade genetic testing to usual care.

Condition or disease

Hereditary Cancer

Intervention/treatment

Enhanced cascade testing

Phase

NA

Detailed Description:

CHARGE study contains two arms: Arm 1) Usual care, comprising of standard genetic counseling and education to probands regarding cascade testing; and Arm 2) Direct mailing of a home genetic testing kit to probands' at-risk relatives that can be returned directly to a commercial genetic testing laboratory, including educational information on the importance and cost of cascade testing

Study Type : INTERVENTIONAL
Estimated Enrollment : 260 participants
Masking : NONE
Primary Purpose : HEALTH_SERVICES_RESEARCH
Official Title : CHARGE: CHOICE ARCHITECTURE IN GENETIC TESTING
Actual Study Start Date : 2024-02-16
Estimated Primary Completion Date : 2025-07-31
Estimated Study Completion Date : 2025-07-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
Criteria
Proband Inclusion Criteria
  • * Have a newly reported pathogenic or likely pathogenic variant in one or more of the following genes: APC, ATM, BRCA1, BRCA2, CDH1, CHEK2, PALB2, MLH1, MSH2, MSH6, PMS2, PTEN, TP53
  • * 18 years of age or older
  • * English fluency
  • * Have at least 1 adult living genetically related relative who resides in Texas
  • Proband Exclusion Criteria
    • * Referred for genetic testing by a relative with a pathogenic variant
    • * Unwilling to be randomized to a study arm
    • Relative Inclusion Criteria
      • * 18 years of age or older
      • * English fluency
      • * Residing in Texas
CHARGE Study: CHoice ARchitecture Genetic tEsting

Location Details

NCT06284330

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Texas

UT Southwestern Medical Center

Dallas, Texas, United States, 75390