Medical Physics Direct Patient Care Initiative - Communication Intervention Study Protocol
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Anxiety
研究概览
简要总结
This phase II trial studies how well medical physics direct patient care works in improving patients' understanding of their cancer treatment. Providing direct physicist-patient interactions and answering patients' questions about their cancer treatment may help patients to understand the care and therefore reduce anxiety and distress during treatment.
详细描述
PRIMARY OBJECTIVE:
I. To evaluate whether the Medical Physics Direct Patient Care Initiative (MPDPCI) improves anxiety/distress.
SECONDARY OBJECTIVE:
II. To assess whether the MPDPCI improves patient treatment adherence and overall satisfaction.
OUTLINE: Patients are randomized to 1 of 2 arms.
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
- 是
入选标准
- •Medical physicists will be eligible if they care for patients within the Gershenson Radiation Oncology Center within the Karmanos Cancer Institute and have completed the patient communication training
- •Are able to read and write in English
- •Are scheduled for curative radiation therapy at the Gershenson Radiation Oncology Center
排除标准
- 未提供
研究组 & 干预措施
Arm I (printed materials)
Patients receive printed materials describing the technical aspects of their treatment.
干预措施: Informational Intervention (Other)
Arm I (printed materials)
Patients receive printed materials describing the technical aspects of their treatment.
干预措施: Questionnaire Administration (Other)
Arm II (printed materials, physicist interaction)
Patients receive printed materials as in Arm I. Patients also receive a minimum of 2 direct physicist interactions to describe the technical aspects of their treatment either immediately prior to or immediately after treatment simulation.
干预措施: Informational Intervention (Other)
Arm II (printed materials, physicist interaction)
Patients receive printed materials as in Arm I. Patients also receive a minimum of 2 direct physicist interactions to describe the technical aspects of their treatment either immediately prior to or immediately after treatment simulation.
干预措施: Counseling (Other)
Arm II (printed materials, physicist interaction)
Patients receive printed materials as in Arm I. Patients also receive a minimum of 2 direct physicist interactions to describe the technical aspects of their treatment either immediately prior to or immediately after treatment simulation.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Anxiety
时间窗: 4 months
Will be assessed using linear mixed-effects models. These objectives will be evaluated based on the difference between groups across three time points (i.e., group-effect) using the baseline corrected measurements. Each patient will be considered as random-effects along with the repeated measurements at three time points. The repeated measurements at three time points will be handled by autocorrelated residuals within groups.
Distress
时间窗: 4 months
Will be assessed using linear mixed-effects models. These objectives will be evaluated based on the difference between groups across three time points (i.e., group-effect) using the baseline corrected measurements. Each patient will be considered as random-effects along with the repeated measurements at three time points. The repeated measurements at three time points will be handled by autocorrelated residuals within groups.
次要结局
- Patient treatment adherence(4 months)
研究者
Jay Burmeister
Principal Investigator
Barbara Ann Karmanos Cancer Institute