Hereditary Cancer
Conditions
Keywords
cascade genetic testing, hybrid type I, feasibility
Brief summary
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
Interventions
OTHEREnhanced cascade testing
Direct mailed at-home genetic testing kit to probands' relatives.
Sponsors
University of Texas Southwestern Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of cascade genetic testing | 3-6 months | Proportion of at-risk relatives who undergo testing |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in probands' family communication about genetic test results as measured by Proband survey | Baseline and 4-7 months | Frequency and content of family communication will be measured by Proband survey (result sharing, reasons for sharing and not sharing) |
| Proband's and relative's satisfaction with decision about participating in study measured at approximately 4- 7 months | Approx. 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. |
| Family functioning as reported by probands and relatives measured by Cancer Family Impact Scale | 4-7 months | 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. |
| Proband's reaction to intervention materials as measured by proband survey. | 4-7 months | 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. |
Countries
United States
Outcome results
None listed