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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06284330
Other study ID # STU-2023-0881
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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