CHARGE Study: CHoice ARchitecture Genetic tEsting
CHARGE
CHARGE: CHOICE ARCHITECTURE IN GENETIC TESTING
1 other identifier
interventional
108
1 country
1
Brief Summary
CHARGE is a hybrid type I feasibility study to compare a choice architecture intervention for cascade genetic testing to usual care.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 1, 2024
CompletedStudy Start
First participant enrolled
February 16, 2024
CompletedFirst Posted
Study publicly available on registry
February 28, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2025
CompletedSeptember 5, 2025
August 1, 2025
1.5 years
February 1, 2024
August 28, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rate of cascade genetic testing
Proportion of at-risk relatives who undergo testing
3-6 months
Secondary Outcomes (4)
Change in probands' family communication about genetic test results as measured by Proband survey
Baseline and 4-7 months
Proband's and relative's satisfaction with decision about participating in study measured at approximately 4- 7 months
Approx. 4-7 months
Family functioning as reported by probands and relatives measured by Cancer Family Impact Scale
4-7 months
Proband's reaction to intervention materials as measured by proband survey.
4-7 months
Study Arms (2)
Standard of care cascade testing
NO INTERVENTIONStandard of care cascade genetic testing
Choice architecture cascade testing
EXPERIMENTALDirect mailed genetic testing kit to probands' relatives.
Interventions
Direct mailed at-home genetic testing kit to probands' relatives.
Eligibility Criteria
You may qualify if:
- 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
- years of age or older
- English fluency
- Have at least 1 adult living genetically related relative who resides in Texas
You may not qualify if:
- Referred for genetic testing by a relative with a pathogenic variant
- Unwilling to be randomized to a study arm
- years of age or older
- English fluency
- Residing in Texas
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UT Southwestern Medical Center
Dallas, Texas, 75390, United States
Related Publications (1)
Makhnoon S, Getchell G, Rodriguez Y, Pena L, Rodriguez J, Ibidapo T, Henrikson NB, Lee M, Wu S, Pirzadeh-Miller S. Choice architecture in cascade genetic testing (CHARGE study) for hereditary cancer: Design of a hybrid type I randomized feasibility trial. Contemp Clin Trials. 2025 Aug;155:107979. doi: 10.1016/j.cct.2025.107979. Epub 2025 Jun 5.
PMID: 40482962DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Sukh Makhnoon, PhD, MS
University of Texas Southwestern Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
February 1, 2024
First Posted
February 28, 2024
Study Start
February 16, 2024
Primary Completion
July 31, 2025
Study Completion
July 31, 2025
Last Updated
September 5, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share