Visually Enhanced Education About Prostate Cancer (VEEP-C): A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Decision-Regret - based on Ottawa scale
研究概览
简要总结
This randomized clinical trial studies how well visually enhanced education works in improving prostate cancer and treatment knowledge in patients with prostate cancer that has not spread to other places in the body. Visually enhanced education includes pictures, drawings, and photos, may help doctors better convey information about radiation and prostate cancer to patients.
详细描述
PRIMARY OBJECTIVES:
I. Our goal is to conduct a randomized controlled trial to determine the impact of a visual presentation in the context of a radiation oncologist's discussion with patient during consultation on patient satisfaction at end of consultation visit and at end of treatment, on anxiety at start of treatment, on decision regret following treatment, and on perception of side effects following treatment. Of note, the attending radiation oncologist will be responsible for reviewing the Powerpoint presentation with the patient, taking time to answer any questions that the patient has
OUTLINE: Patients are randomized into 1 of 2 arms.
ARM A (STANDARD EDUCATION): Patients receive a standard prostate cancer radiation oncology consultation.
ARM B (VISUAL ENHANCED EDUCATION): Patients receive a visually enhanced prostate cancer educational Powerpoint presentation including prostate anatomy, pathologic results, surgical options, radiation therapy, and prognosis with pictographs during radiation oncology consultation.
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
- Male
- 接受健康志愿者
- 否
入选标准
- •Patient must have non-metastatic, biopsy proven prostate cancer
- •Must be referred to radiation oncology clinic
排除标准
- •Prior surgery or radiation therapy for prostate cancer
- •Patients who are blind are excluded
结局指标
主要结局
Decision-Regret - based on Ottawa scale
时间窗: Up to 12 weeks
Sample size was determined based on this primary outcome - with estimated mean of 16 in Arm A and mean of 8 in Arm B, with standard deviation of 15, with 80% power and alpha of 0.05.
次要结局
- Satisfaction - SCA(baseline, end of treatment, and long-term follow-up)
- Symptoms based on EPIC-26 short form(baseline, end of treatment, and long-term follow-up)
- Anxiety - Memorial MAX-PC scale(1 week)
研究者
Austin Kirschner
Principal Investigator
Vanderbilt-Ingram Cancer Center