Helping Oncology Patients Explore-Genomics (HOPE-Genomics) Web Tool Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 465
- 试验地点
- 1
- 主要终点
- Recall Rates of Personal Genomic Results
研究概览
简要总结
This clinical trial studies the effectiveness of a web-based cancer education tool called Helping Oncology Patients Explore Genomics (HOPE-Genomics) in improving patient knowledge of personal genomic testing results and cancer and genomics in general. HOPE-Genomics is a web-based education tool that teaches cancer/leukemia patients, and patients who may be at high-risk for developing cancer, about genomic testing and provide patients with information about their own genomic test results. The HOPE-Genomics tool may improve patient's genomic knowledge and quality of patient-centered care. In addition, it may also improve education and care quality for future patients.
详细描述
PRIMARY OBJECTIVES:
I. Test the efficacy of the HOPE-Genomics intervention in improving patient knowledge of genomics.
II. Test the efficacy of the HOPE-Genomics intervention in improving patient receipt of guideline-concordant care.
OUTLINE: Patients are randomized to 1 of 3 arms.
ARM I (USUAL CARE): Patients receive education pamphlet about whole-genome sequencing (WES) and have their genomics test results returned by their clinician in a typical manner.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •Are enrolled in City of Hope (COH) Institutional Review Board (IRB) 07047
- •Have a diagnosis of lung, breast, colorectal, pancreatic, ovarian or prostate cancer
- •Having somatic, germline or paired somatic/germline sequencing
- •Are fluent in English
- •Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- •Are >= 18 years old
排除标准
- •Are unable to provide informed consent
研究组 & 干预措施
Arm I (usual care)
Patients receive education pamphlet about WES and have their genomics test results returned by their clinician in a typical manner.
干预措施: Best Practice (Other)
Arm I (usual care)
Patients receive education pamphlet about WES and have their genomics test results returned by their clinician in a typical manner.
干预措施: Survey Administration (Other)
Arm II (genomics test results, HOPE-Genomics)
Patients receive their genomics test results both from their clinician and from the HOPE-Genomics tool. Patients then view HOPE-Genomics tool over 15-20 minutes after their results are available.
干预措施: Educational Intervention (Other)
Arm II (genomics test results, HOPE-Genomics)
Patients receive their genomics test results both from their clinician and from the HOPE-Genomics tool. Patients then view HOPE-Genomics tool over 15-20 minutes after their results are available.
干预措施: Genomic Profile (Procedure)
Arm II (genomics test results, HOPE-Genomics)
Patients receive their genomics test results both from their clinician and from the HOPE-Genomics tool. Patients then view HOPE-Genomics tool over 15-20 minutes after their results are available.
干预措施: Survey Administration (Other)
Arm III (HOPE-Genomics, genomics test results)
Patients view HOPE-Genomics tool (containing educational content) over 15-20 minutes before their sequencing results are available. Patients also receive their genomics test results both from their clinician and from the HOPE-Genomics tool.
干预措施: Educational Intervention (Other)
Arm III (HOPE-Genomics, genomics test results)
Patients view HOPE-Genomics tool (containing educational content) over 15-20 minutes before their sequencing results are available. Patients also receive their genomics test results both from their clinician and from the HOPE-Genomics tool.
干预措施: Survey Administration (Other)
结局指标
主要结局
Recall Rates of Personal Genomic Results
时间窗: Up to 3 months
Recall rate refers to the proportion of patients who accurately remembered whether they had undergone genetic testing, as reported in the 10-day follow-up survey. If a patient's response at the 10-day mark was unavailable, their answer from the 3-month survey was used as a substitute. This metric helps assess how well patients retained and understood information about their genetic testing experience shortly after receiving their results.
次要结局
- Operationalization of Contextual Guideline Concordant Care(Up to 12-month period after results disclosure)