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临床试验/NCT04266522
NCT04266522已完成不适用

Medical Physics Direct Patient Care Initiative - Communication Intervention Study Protocol

Barbara Ann Karmanos Cancer Institute2 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2020年1月16日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
45
试验地点
2
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

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jay Burmeister

Principal Investigator

Barbara Ann Karmanos Cancer Institute

研究点 (2)

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