Washington University Participant Engagement and Cancer Genomic Sequencing Center (WU-PE-CGS)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 990
- 试验地点
- 2
- 主要终点
- Participant knowledge of clinical genetic testing
研究概览
简要总结
The overall goal of the WU-PE-CGS is to build a rigorous, scientific evidence base for approaches that direct engagement of cancer patients and post-treatment cancer survivors as participants in cancer research, and to investigate the impact of directly engaging participants in decisions regarding returning of genomic results on participants' health and satisfaction. Participants in this study will be presented with the choice of types of genomic results to receive, and the Engagement Optimization Unit (EOU) will investigate the impact of this intervention on participant knowledge, expectations of benefit, personal utility, and decisional conflict.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligibility Criteria:
- •Patients with cholangiocarcinoma, multiple myeloma, or early onset colon or rectal cancer.
- •If diagnosed with multiple myeloma, must be African-American.
- •If diagnosed with colon or rectal cancer, must be African-American AND must be no older than 65 years old at the time of diagnosis.
- •At least 18 years old
- •Able to understand and willing to sign an IRB-approved written informed consent document
排除标准
- 未提供
研究组 & 干预措施
No Return of Genetic Results
Participants will undergo germline genomic sequencing as part of consenting to the WU-PE-CGS program.
Participants will be given the option to receive the results from the genomic sequencing. After they consent to the study, the types of results available to them will be explained by research staff. Participants will be able to choose to receive: (1) no results, or any combination of (2) biomarker information from cancer cells, (3) inherited mutations related to cancer, and (4) inherited mutations related to other medical issues. These choices will be presented to them via a discussion with study staff with accompanying paper information
Return of Genetic Results
Participants will undergo germline genomic sequencing as part of consenting to the WU-PE-CGS program.
Participants will be given the option to receive the results from the genomic sequencing. After they consent to the study, the types of results available to them will be explained by research staff. Participants will be able to choose to receive: (1) no results, or any combination of (2) biomarker information from cancer cells, (3) inherited mutations related to cancer, and (4) inherited mutations related to other medical issues. These choices will be presented to them via a discussion with study staff with accompanying paper information
干预措施: Return of Genetic Results: Biomarker information from cancer cells (Other)
Return of Genetic Results
Participants will undergo germline genomic sequencing as part of consenting to the WU-PE-CGS program.
Participants will be given the option to receive the results from the genomic sequencing. After they consent to the study, the types of results available to them will be explained by research staff. Participants will be able to choose to receive: (1) no results, or any combination of (2) biomarker information from cancer cells, (3) inherited mutations related to cancer, and (4) inherited mutations related to other medical issues. These choices will be presented to them via a discussion with study staff with accompanying paper information
干预措施: Return of Genetic Results: Inherited mutations related to cancer (Other)
Return of Genetic Results
Participants will undergo germline genomic sequencing as part of consenting to the WU-PE-CGS program.
Participants will be given the option to receive the results from the genomic sequencing. After they consent to the study, the types of results available to them will be explained by research staff. Participants will be able to choose to receive: (1) no results, or any combination of (2) biomarker information from cancer cells, (3) inherited mutations related to cancer, and (4) inherited mutations related to other medical issues. These choices will be presented to them via a discussion with study staff with accompanying paper information
干预措施: Return of Genetic Results: Inherited mutations related to other medical issues (Other)
结局指标
主要结局
Participant knowledge of clinical genetic testing
时间窗: Through completion of follow-up (estimated to be 5 years)
11-item, Likert scale. This scale has 5 points ranging from strongly agree to strongly disagree. 1=Strongly Agree, 2=Agree, 3=Neither Agree nor Disagree, 4=Disagree, 5=Strongly Disagree for items (4, 6-11) are scored such that 'strong disagree' reflects a correct response and 'somewhat disagree' reflects a less confident correct response in the correct direction. Negatively worded items (items 1, 2, 3, and 5) are reverse scored so that 'strongly agree' reflects a correct response and 'somewhat agree' reflect a less confident response in the correct direction. This will be scored by adding up the numbers for each of the 11 items regarding participant knowledge of clinical genetic testing. The total score ranges from 5 to 55. A higher score for the participant represents higher participant knowledge.
Participant expectations of benefit
时间窗: Through completion of follow-up (estimated to be 5 years)
Participants will rate their expectation for 6 potential benefits of cancer genomic sequencing on a 4-point scale ranging from extremely unlikely to extremely likely. . 1=Strongly Agree, 2=Agree, 3=Disagree, 4=Strongly Disagree. This will be scored by adding up the numbers for each of the 8 items regarding participant expectations of benefit. The total score ranges from 6 to 24. A higher score for the participant represents higher levels of expectations.
Participant personal utility
时间窗: Through completion of follow-up (estimated to be 5 years)
Participant personal utility will be measured on a 7-point scale ranging from not at all useful to extremely useful. 1=Not at all useful, 2=A little useful, 3=Somewhat useful, 4=Neutral, 5=Useful, 6=Very useful, 7=Extremely useful. This will be scored by adding up the numbers for each of the 14 items regarding participant personal utility. The total score ranges from 14 to 98. A higher score for the participant represents higher personal utility.
次要结局
- Participant satisfaction(Through completion of follow-up (estimated to be 5 years))
- Participant anxiety(Through completion of follow-up (estimated to be 5 years))