CHARGE Study: CHoice ARchitecture Genetic tEsting (CHARGE)

CHARGE: CHOICE ARCHITECTURE IN GENETIC TESTING

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

Study Overview

• Status: Recruiting
• Conditions: Hereditary Cancer
• Intervention / Treatment: Other: Enhanced cascade testing

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
• Enrollment (Estimated): 260
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sukh Makhnoon, PhD, MS; Phone Number: 214-638-3242; Email: Chargestudy@utsouthwestern.edu

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75390
      • Recruiting
      • UT Southwestern Medical Center
      • Principal Investigator: Sukh Makhnoon, PhD, MS
      • Contact: Sukh Makhnoon, PhD, MS; Phone Number: 214-648-3242; Email: Chargestudy@utsouthwestern.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard of care cascade testing; Standard of care cascade genetic testing
Experimental: Choice architecture cascade testing; Direct mailed genetic testing kit to probands' relatives.	Other: Enhanced cascade testing; Direct mailed at-home genetic testing kit to probands' relatives.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of cascade genetic testing	Proportion of at-risk relatives who undergo testing	3-6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: University of Texas Southwestern Medical Center
• Investigators: Principal Investigator: Sukh Makhnoon, PhD, MS, UT Southwestern Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): February 16, 2024
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: February 1, 2024
• First Submitted That Met QC Criteria: February 27, 2024
• First Posted (Actual): February 28, 2024

Study Record Updates

• Last Update Posted (Actual): April 5, 2024
• Last Update Submitted That Met QC Criteria: April 3, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: feasibility; cascade genetic testing; hybrid type I
• Other Study ID Numbers: STU-2023-0881

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No