Video Intervention to Address Pre-Test Patient Education for Tumor Genomic Testing
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 243
- 试验地点
- 7
- 主要终点
- Message-specific knowledge/recall accuracy
研究概览
简要总结
This clinical trial tests whether a video intervention improves patient understanding of tumor genomic testing in patients with cancer that has spread to other parts of the body (metastatic). Measuring how the video intervention affects patient understanding of tumor genomic testing in patients with metastatic cancer may help doctors provide patient-centered care by effectively communicating the importance of tumor genomic testing.
详细描述
PRIMARY OBJECTIVE:
I. To assess change in patient knowledge about tumor next generation sequencing (NGS) following exposure to the video.
SECONDARY OBJECTIVES:
I.To assess changes following exposure to the video, including; Ia. Genomic knowledge via the validated 10 true/false question survey (% correct out of 10).
Ib. 11-item Trust in Physician Survey (TPS) as a single TPS score. Ic. Comparison of results in three patient cohorts: 1) Metastatic breast cancer; 2) lung cancer; 3) metastatic cancer of unspecified type.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Patients must have biopsy-confirmed metastatic cancer
- •Be >= 18 years of age
- •Be undergoing clinical tumor or circulating tumor deoxyribonucleic acid (DNA) NGS
排除标准
- •Exclude patients who are not English- or Spanish-speaking
研究组 & 干预措施
Health services research (video)
Patients participate in a video intervention session and complete questionnaires at baseline, after participating in the video intervention, and after receiving NGS results.
干预措施: Health Education (Behavioral)
Health services research (video)
Patients participate in a video intervention session and complete questionnaires at baseline, after participating in the video intervention, and after receiving NGS results.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Message-specific knowledge/recall accuracy
时间窗: Immediately before and immediately after video intervention
Measured as number correct out of 10 questions. Will have 90% power to detect an effect size of 0.47 in change of recall accuracy from pre- to post- video intervention, using a two-sided Wilcoxon signed-rank test with alpha of 0.05.
Message-specific Knowledge/Recall Accuracy
时间窗: At T1 (baseline), at T2 (within 27-days of baseline, all following video viewing and on the same date as video viewing), and at T3 (Up to 288 days after baseline)
Measured as percentage correct out of 10 questions. Will have 90% power to detect an effect size of 0.47 in change of recall accuracy from pre- to post- video intervention, using a two-sided Wilcoxon signed-rank test with alpha of 0.05.
次要结局
- Change in patient trust of physician/provider in MBC versus MLC patients(Immediately before and immediately after video intervention)
- Change in patient trust of physician/provider(Immediately before and immediately after video intervention)
- Change in patient genomic knowledge(Immediately before and immediately after video intervention)
- Change in patient genomic knowledge in metastatic breast cancer (MBC) versus metastatic lung cancer (MLC) patients(Immediately before and immediately after video intervention)
- Patient Genomic Knowledge(At T1 (baseline), at T2 (within 27-days of baseline, all following video viewing and on the same date as video viewing), and at T3 (Up to 288 days after baseline))
- Patient Trust of Physician/Provider(At T1 (baseline), at T2 (within 27-days of baseline, all following video viewing and on the same date as video viewing), and at T3 (Up to 288 days after baseline))
- Change in Patient Genomic Knowledge in Metastatic Breast Cancer (MBC) Versus Metastatic Lung Cancer (MLC) Patients(At T1 (baseline), at T2 (within 27-days of baseline, all following video viewing and on the same date as video viewing), and at T3 (Up to 288 days after baseline))
- Change in Patient Trust of Physician/Provider in MBC Versus MLC Patients(At T1 (baseline), at T2 (within 27-days of baseline, all following video viewing and on the same date as video viewing), and at T3 (Up to 288 days after baseline))
研究者
Daniel Stover
Principal Investigator
Ohio State University Comprehensive Cancer Center