CHARGE Study: CHoice ARchitecture Genetic tEsting

The University of Texas System (UT)

Status: Enrolling

Conditions: Hereditary Cancer

Treatments: Other: Enhanced cascade testing

Study type: Interventional

Funder types: Other

Identifiers

NCT06284330

STU-2023-0881

Details and patient eligibility

About

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

Full 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

Enrollment: 260 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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260 participants in 2 patient groups

Standard of care cascade testing

No Intervention group

Description:

Standard of care cascade genetic testing

Choice architecture cascade testing

Experimental group

Description:

Direct mailed genetic testing kit to probands' relatives.

Treatment:

Other: Enhanced cascade testing