Hereditary CancerCHARGENCT06284330
CHARGE Study: CHoice ARchitecture Genetic tEsting
A study testing Enhanced cascade testing in people with Hereditary Cancer, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
CHARGE is a hybrid type I feasibility study to compare a choice architecture intervention for cascade genetic testing to usual care. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hereditary Cancer
- What is being tested?
- Enhanced cascade testing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Feb 2024to 31 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Conditions
- Hereditary Cancer
- Being tested
- Enhanced cascade testing
- Keywords
- cascade genetic testing, hybrid type I, feasibility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced cascade testingOther
Direct mailed at-home genetic testing kit to probands' relatives.
| Study group | Role | What they receive |
|---|---|---|
| Standard of care cascade testing | No intervention | Standard of care cascade genetic testing |
| Choice architecture cascade testing | Experimental | Direct mailed genetic testing kit to probands' relatives. Receives: Other: Enhanced cascade testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of cascade genetic testing
Proportion of at-risk relatives who undergo testing
Measured: 3-6 months
Secondary outcomes (4)
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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 4-7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start16 Feb 2024
- Primary completion31 Jul 2025
- Study completion31 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hereditary CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sukh Makhnoon, University of Texas Southwestern Medical Center
- Investigators
- Sukh Makhnoon, PhD, MS, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06284330
- Sponsor's protocol ID
- STU-2023-0881
- Acronym
- CHARGE
- Status last verified
- Aug 2025
- First submitted
- 1 Feb 2024
- Last updated
- 5 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40482962
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CHARGE: CHOICE ARCHITECTURE IN GENETIC TESTING
- ClinicalTrials.gov ID
- NCT06284330
- Acronym / sponsor ID
- CHARGE / STU-2023-0881
- Conditions
- Hereditary Cancer
- Keywords
- cascade genetic testing, hybrid type I, feasibility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 16 Feb 2024 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 28 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of care cascade testing | No intervention | –Standard of care cascade genetic testing |
| Choice architecture cascade testing | Experimental | Other: Enhanced cascade testingDirect mailed genetic testing kit to probands' relatives. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enhanced cascade testingDirect mailed at-home genetic testing kit to probands' relatives. | Other | Choice architecture cascade testing |
Primary outcome
Rate of cascade genetic testing
Time frame: 3-6 months
Proportion of at-risk relatives who undergo testing
4 secondary outcomes
Change in probands' family communication about genetic test results as measured by Proband survey
Time frame: Baseline and 4-7 months
Proband's and relative's satisfaction with decision about participating in study measured at approximately 4- 7 months
Time frame: Approx. 4-7 months
Family functioning as reported by probands and relatives measured by Cancer Family Impact Scale
Time frame: 4-7 months
Proband's reaction to intervention materials as measured by proband survey.
Time frame: 4-7 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2025.
- Derived from this study: PubMed 40482962Makhnoon 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sukh Makhnoon, PhD, MS principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced cascade testing in people with Hereditary Cancer, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of cascade genetic testing (time frame: 3-6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06284330, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2025; AzTrials last refreshed its copy on 30 Oct 2026.