CHARGE Study: CHoice ARchitecture Genetic tEsting

Hereditary Cancer Clinical Trial

— CHARGE  

Official title:

CHARGE: CHOICE ARCHITECTURE IN GENETIC TESTING

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06284330
• Other study ID #: STU-2023-0881
• Status: Recruiting
• Phase: N/A
• Start date: February 16, 2024
• Est. completion date: August 2025

Study information

• Verified date: April 2024
• Source: University of Texas Southwestern Medical Center
• Contact: Sukh Makhnoon, PhD, MS
• Phone: 214-638-3242
• Email: Chargestudy[@]utsouthwestern.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 260
• Est. completion date: August 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hereditary Cancer

Intervention

Other:
• Enhanced cascade testing
Direct mailed at-home genetic testing kit to probands' relatives.

Locations

Country	Name	City	State
United States	UT Southwestern Medical Center	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of cascade genetic testing	Proportion of at-risk relatives who undergo testing	3-6 months
Secondary	Change in probands' family communication about genetic test results as measured by Proband survey	Frequency and content of family communication will be measured by Proband survey (result sharing, reasons for sharing and not sharing)	Baseline and 4-7 months
Secondary	Proband's and relative's satisfaction with decision about participating in study measured at approximately 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.	Approx. 4-7 months
Secondary	Family functioning as reported by probands and relatives measured by Cancer Family Impact Scale	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.	4-7 months
Secondary	Proband's reaction to intervention materials as measured by proband survey.	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.	4-7 months