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临床试验/NCT04362306
NCT04362306已完成不适用

Radiation Oncology Patient Medical Physics Intervention Study

The University of Texas Health Science Center at San Antonio1 个研究点 分布在 1 个国家目标入组 89 人开始时间: 2020年3月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
89
试验地点
1
主要终点
Patient Satisfaction

研究概览

简要总结

This investigation is designed to be a two-arm, non-randomized prospective phase 2 study evaluating the impact of medical physicist patient intervention on the anxiety level and patient satisfaction of patients undergoing a course of radiation therapy. The goal is to demonstrate that these interventions will have a significantly positive impact on the overall well-being of the oncology patients.

研究设计

研究类型
Interventional
分配方式
Non 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

  • •Age >/= 18 years
  • •Patients receiving treatment in the outpatient setting.
  • •Patients with an Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0, 1, or 2.

排除标准

  • •Patients receiving a single fraction of treatment.
  • •History of Prior Radiation.

研究组 & 干预措施

Planned Intervention

Experimental

Patients will be scheduled for CT (computed tomography ) simulation for radiation treatment planning. Prior to simulation, patients will be asked to complete anxiety and patient satisfaction questionnaires. Following completion of the questionnaires, each patient will receive the first intervention with a member of the medical physics team to review the process of simulation, treatment planning, and subsequent treatment. This meeting will last approximately 15 minutes and at this time, the team member will explain that they are the primary resource for all the technical aspects related to the patient's treatment. Additionally, they will identify and address any concerns that patients or their caregivers have with radiation treatment and the patient will be shown the simulation infographic. The patient will then be asked to complete a second set of anxiety and patient satisfaction questionnaires and will then undergo the planned simulation.

干预措施: Planned Intervention (Behavioral)

No Planned Intervention

Active Comparator

After patients are enrolled into this study, they will be scheduled for CT simulation for radiation treatment planning. Prior to simulation, patients will receive anxiety and patient satisfaction questionnaires to complete

干预措施: No planned intervention (Behavioral)

结局指标

主要结局

Patient Satisfaction

时间窗: Baseline to last treatment (up to 9 weeks)

Change in mean Function Assessment of Chronic Illness Therapy Treatment Satisfaction Patient Satisfaction score for the control and intervention groups will be compared.

Anxiety Inventory

时间窗: Baseline to last treatment (up to 9 weeks)

The change in score from 6 questions in the validated short-form of the Spielberger State-Trait Anxiety Inventory (STAI).10 The mean medical physics intervention cohort anxiety score will be calculated at each of the 4 time points and compare to the same time points for the control cohort.

次要结局

  • Medical competency/health literacy of Spanish speaking patients(Prior to CT simulation)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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