A Randomized Clinical Trial to Study the Utility of Visually Inspired Patient Education Material on Willingness to Pursue Radiation Therapy in American Indian and Alaska Native Individuals (VIEW Study)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Mayo Clinic
- 入组人数
- 51
- 试验地点
- 2
- 主要终点
- Change in patient anxiety
研究概览
简要总结
This research study is being done in order to better understand and identify American Indian/Alaskan Native (AI/AN) cancer patients' attitudes and beliefs towards radiation therapy treatment plans and their willingness to pursue them.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •Patient at least 18 years of age with cancer diagnosis.
- •Radiation therapy is recommended for their cancer treatment as a next step in their cancer care.
- •Cognitive capacity to complete a paper-and-pencil survey.
- •Ability to communicate and understand English with proficiency to provide informed consent and complete a paper-and-pencil survey.
排除标准
- •Patient < 18 years of age.
- •Patient does not have a cancer diagnosis.
结局指标
主要结局
Change in patient anxiety
时间窗: Baseline, day 14
Measured using self-reported Hospital Anxiety and Depression Scale (HADS) Survey to ascertain any anxiety and/or depression that they may be experiencing with respect to their diagnosis and treatment. Questionnaire total score reported on a scale of 0-7 = normal, 8-10 borderline abnormal (borderline case), 11-21 abnormal (case)
Radiotherapy completion rates in the AI/AN community
时间窗: 90 days
Number of participates to complete radiation therapy as prescribed
Change in patient perception of information received
时间窗: Baseline, day 14
Measured by the EORTC QLQ - INFO25 survey, which is a validated instrument that will gauge their satisfaction with the information they received regarding their diagnosis and treatment plan. Questionnaire of 24 questions regarding information received during treatment using a scale of 1 (not at all) to 4 (very much).
次要结局
未报告次要终点