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CHARGE is a hybrid type I feasibility study to compare a choice architecture intervention for cascade genetic testing to usual care.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enhanced cascade testing | Other | Direct mailed at-home genetic testing kit to probands' relatives. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of cascade genetic testing | Proportion of at-risk relatives who undergo testing | 3-6 months |
| 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 |
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Proband Inclusion Criteria:
Proband Exclusion Criteria:
Relative Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sukh Makhnoon, PhD, MS | University of Texas Southwestern Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UT Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40482962 | Derived | 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. |
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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 |