A Randomized Controlled Trial Comparing a Genetic Counseling Patient Preference Intervention vs. Conventional Genetic Counseling for Women at Elevated Risk for Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 874
- 试验地点
- 2
- 主要终点
- Adherence to NCCN guidelines of having an annual mammogram (and breast magnetic resonance imaging [MRI] with contrast if recommended)
研究概览
简要总结
This stage I clinical trial compares a genetic counseling patient preference (GCPP) intervention via EHR MyChart patient portal to conventional genetic counseling for women at elevated risk for breast cancer. Women at elevated breast cancer risk may be offered genetic counseling and genetic testing to further define whether they are at high risk (e.g. hereditary risk; BRCA mutation positive); moderate risk (e.g. risk based largely on family history and/or polygenic risk score) or average risk (e.g. general population). Genetic counseling may improve basic genetic knowledge, produce more accurate risk perceptions and tailor recommendations for greater perceived personal control regarding breast cancer risk. A single approach to genetic counseling may not fit the needs for all patients, and genetic counseling models that increase access to genetic testing and are more patient-centered may better serve patients. This trial may help researchers determine if a GCPP intervention can take the place of conventional genetic counseling, while being non-inferior in terms of adherence to screening recommendations, breast cancer genetic knowledge, accurate perception of risk, breast cancer-specific worry, and satisfaction with counseling compared to conventional genetic counseling. Study results will provide the efficacy for using a novel cancer genetic counseling approach via EHR MyChart patient portal that will be readily adaptable to other health care systems in the future, inform best practices, and reduce workforce burden.
详细描述
PRIMARY OBJECTIVE:
I. Determine the efficacy of genetic counseling patient preference (GCPP) compared to conventional genetic counseling for adherence to National Comprehensive Cancer Network (NCCN) guidelines for having: 1) a clinical encounter every 6-12 months; and 2) an annual mammogram (and breast magnetic resonance imaging [MRI] with contrast if recommended).
II. Determine the efficacy of the GCPP compared to conventional genetic counseling for adherence to other NCCN recommended cancer screening (e.g. colorectal cancer screening).
III. Determine the efficacy of the GCPP compared to conventional genetic counseling on breast cancer genetic knowledge, the accurate perception of breast cancer risk, breast cancer-specific worry, post-test/counseling distress, and satisfaction with counseling.
EXPLORATORY OBJECTIVE:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 64 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Being female.
- •Being an Ohio State University (OSU) patient who uses MyChart.
- •Undergoing routine screening mammography.
- •Normal BI-RADS
- •At elevated breast cancer risk by the Cancer Risk Assessment (CRA) tool.
- •Able to read and speak English.
- •Provide consent.
排除标准
- •Previous genetic counseling.
- •Previous genetic testing for cancer risk or known mutation in a breast cancer gene: ATM, BARD1, BRCA1, BRCA2, CDH1, CHEK2, NBN, PALB2, PTEN, TP
- •Previous diagnosis of breast or ovarian cancer or personal history of lobular carcinoma in situ (LCIS) or breast hyperplasia (with or without atypia).
- •Being a member of a focus group that assisted with the development of the intervention.
研究组 & 干预措施
Arm I (GCPP intervention)
Patients receive GCPP intervention consisting of a series of educational videos on pre-genetic test information.
干预措施: Educational Intervention (Other)
Arm I (GCPP intervention)
Patients receive GCPP intervention consisting of a series of educational videos on pre-genetic test information.
干预措施: Survey Administration (Other)
Arm II (conventional genetic counseling)
Patients receive conventional genetic counseling.
干预措施: Genetic Counseling (Other)
Arm II (conventional genetic counseling)
Patients receive conventional genetic counseling.
干预措施: Survey Administration (Other)
结局指标
主要结局
Adherence to NCCN guidelines of having an annual mammogram (and breast magnetic resonance imaging [MRI] with contrast if recommended)
时间窗: Up to 14 months
Non-inferiority will be assessed by constructing a one-sided 95% confidence interval for the effect of GCCP versus conventional counseling and comparing the bound to a non-inferiority margin. Will use mixed effects logistic regression with adherence as the outcome, random intercept effects for genetic counselors, and fixed effects for study arm, breast cancer knowledge, breast cancer worry, post-test/counseling distress, and perception of breast cancer risk.
Adherence to National Comprehensive Cancer Network (NCCN) guidelines of having a clinical encounter every 6-12 months
时间窗: Up to 14 months
Non-inferiority will be assessed by constructing a one-sided 95% confidence interval for the effect of genetic counseling patient preference (GCCP) versus conventional counseling and comparing the bound to a non-inferiority margin. Will use mixed effects logistic regression with adherence as the outcome, random intercept effects for genetic counselors, and fixed effects for study arm, breast cancer knowledge, breast cancer worry, post-test/counseling distress, and perception of breast cancer risk.
Risk perception
时间窗: Up to 14 months
Determine the efficacy of the GCPP compared to conventional genetic counseling on breast cancer genetic knowledge, the accurate perception of breast cancer risk, breast cancer-specific worry, post-test/counseling distress, and satisfaction with counseling. Non-inferiority will be assessed by constructing a one-sided 95% confidence interval for the effect of GCCP versus conventional counseling and comparing the bound to a non-inferiority margin.
Breast cancer-specific worry
时间窗: Up to 14 months
Determine the efficacy of the GCPP compared to conventional genetic counseling on breast cancer genetic knowledge, the accurate perception of breast cancer risk, breast cancer-specific worry, post-test/counseling distress, and satisfaction with counseling. Non-inferiority will be assessed by constructing a one-sided 95% confidence interval for the effect of GCCP versus conventional counseling and comparing the bound to a non-inferiority margin.
Post-test/counseling distress
时间窗: Up to 14 months
Determine the efficacy of the GCPP compared to conventional genetic counseling on breast cancer genetic knowledge, the accurate perception of breast cancer risk, breast cancer-specific worry, post-test/counseling distress, and satisfaction with counseling. Non-inferiority will be assessed by constructing a one-sided 95% confidence interval for the effect of GCCP versus conventional counseling and comparing the bound to a non-inferiority margin.
Satisfaction with counseling
时间窗: Up to 14 months
Determine the efficacy of the GCPP compared to conventional genetic counseling on breast cancer genetic knowledge, the accurate perception of breast cancer risk, breast cancer-specific worry, post-test/counseling distress, and satisfaction with counseling. Non-inferiority will be assessed by constructing a one-sided 95% confidence interval for the effect of GCCP versus conventional counseling and comparing the bound to a non-inferiority margin.
次要结局
- Adherence to other National Comprehensive Cancer Network (NCCN) recommended cancer screening (e.g. colorectal cancer screening)(Up to 14 months)
研究者
Kevin Sweet
Principal Investigator
Ohio State University Comprehensive Cancer Center