CHARGE Study: CHoice ARchitecture Genetic tEsting

Not Applicable

Recruiting

• Conditions: Hereditary Cancer
• Interventions: Other: Enhanced cascade testing

• Registration Number: NCT06284330
• Lead Sponsor: University of Texas Southwestern Medical Center

Brief Summary

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

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 Timeline

• Study First Submitted: 2024-02-01
• Study Start: 2024-02-16
• Study First Submitted QC: 2024-02-27
• Study First Posted: 2024-02-28
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-05
• Last Update Posted: 2025-05-08
• Primary Completion: 2025-07-31
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 260

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Choice architecture cascade testing	Enhanced cascade testing	Direct mailed genetic testing kit to probands' relatives.

Primary Outcome Measures

Name	Time	Method
Rate of cascade genetic testing	3-6 months	Proportion of at-risk relatives who undergo testing

Secondary Outcome Measures

Name	Time	Method
Change in probands' family communication about genetic test results as measured by Proband survey	Baseline and 4-7 months	Frequency and content of family communication will be measured by Proband survey (result sharing, reasons for sharing and not sharing)
Family functioning as reported by probands and relatives measured by Cancer Family Impact Scale	4-7 months	Relatives' and probands' family functioning will be measured by a survey that includes the adapted Cancer Family Impact Scale. Participants responses to the 18 items of CFIS on a 5-point Likert scale are summed for scoring. Higher summed scores indicated a greater communication and flow of about cancer information within family and therefore better family functioning.
Proband's and relative's satisfaction with decision about participating in study measured at approximately 4- 7 months	Approx. 4-7 months	Probands' and relative's satisfaction with decision about participating in study will be measured at approximately 4- 7 months using surveys (intervention arm). This is measured using the satisfaction with decision scale.
Proband's reaction to intervention materials as measured by proband survey.	4-7 months	Proband survey will include adapted versions of usability questions, commonly used in usability tests of eHealth tools that assess satisfaction, liking, ease of use, and preference. Possible scores range from 0-5 where lower score indicates better outcome.

Trial Locations

Locations (1)

UT Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States