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Completed

NCT Number: NCT06284330

CHARGE Study: CHoice ARchitecture Genetic tEsting

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

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Key information

Conditions

Hereditary Cancer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Enhanced cascade testing

Other

Direct mailed at-home genetic testing kit to probands' relatives.

Primary outcomes

  1. Rate of cascade genetic testing

    Time frame: 3-6 months

    Proportion of at-risk relatives who undergo testing

Secondary outcomes

  1. Change in probands' family communication about genetic test results as measured by Proband survey

    Time frame: 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)

  2. Proband's and relative's satisfaction with decision about participating in study measured at approximately 4- 7 months

    Time frame: 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.

  3. Family functioning as reported by probands and relatives measured by Cancer Family Impact Scale

    Time frame: 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.

  4. Proband's reaction to intervention materials as measured by proband survey.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Registry information

Official study title

CHARGE: CHOICE ARCHITECTURE IN GENETIC TESTING

Acronym: CHARGE

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 28, 2024
Registry last updated
Sep 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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