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Impact on Instructional Video on Patients' Compliance With Preparation During CT Planning for Prostate Cancer

2016年12月28日 更新者:Krista Dawdy、Sunnybrook Health Sciences Centre

Empowering Patients Through Education- Online, Written, and Personal Education Resource for Prostate Cancer Patients Who Need Radiation Therapy to Ensure Patient Preparedness (Compliance and Understanding) for Their Simulation and Treatment

Rectal toxicity limits dose escalated intensity modulated radiotherapy (IMRT) for prostate cancer. The dose volume constraints that predict for rectal toxicity require minimizing prostate motion and rectum and bladder filling of IMRT .5-15 . The volumetric changes and internal organ motion during prostate IMRT increases risk of PSA failure in patients with large rectums at the planning CT scans. Patient preparation for IMRT planning is crucial .The literature is limited regarding the effectiveness of educational intervention with behavioral reinforcement for patients, and a gap if exists literacy level is considered. Patients often cannot comprehend verbal or written instructions and have difficulties following through with recommended regimens.23 Using multimedia such as Internet, audio-visual media such as DVD and even the telephone can enhance patients' knowledge and understanding about importance of preparation for IMRT for prostate ca. Thomas's study showed that in patients undergoing radiotherapy and chemotherapy, the video group had lower anxiety scores compared with the non video group. At SOCC patients have been provided with verbal information about bladder and rectum preparation for prostate planning CT scan and IMRT. Patients should have a "fullish" bladder and empty rectum at the time of CT simulation. If the rectal diameter is > 4cm, the patient will be asked to empty his stool/gas and re-scanned. The 3- months review of patients preparedness for prostate IMRT showed that only 13/55 patients were adequately prepared but 42/55 (76%) of patients needed to be re-scanned due to inadequate bladder (21/42, 50%) or rectum filling 28/42, 67%) . Also, 2/13 (15%) patients were still not prepared at the second resimulation despite that they received a phone call with the instructions. The investigators plan to investigate if a multimedia education strategy will decrease costly resimulation rate for patients with prostate cancer.

研究概览

地位

完全的

详细说明

An estimated 23,600 men will be diagnosed with prostate cancer in Canada in 2014. This represents 24% of all new cancer cases in men in 2014. The SOCC treats 1000 patients with prostate cancer annually. Patients who fail to follow instructions for the initial prostate planning CT scan need to return to be rescanned at a later date. Additional CTs can increase patients' parking and transportation costs and may increase their anxiety. Rescanning may also cause stress to radiation therapists due to unsuccessful planning, increase costs to the cancer centre for the additional time of radiation therapists and increase the planning CT wait time for other patients. Thus improving patients' preparedness for the prostate planning CT scan will reduce costs for patients and the hospital, reduce anxiety and stress for both patients and practitioners, reduce CT scan wait times, maximize the accuracy of prostate IMRT. In a study of 220 patients receiving chemotherapy or radiotherapy, Thomas used video education and the Hospital Anxiety and Depression Scale (HAD) and found a significant correlation between satisfaction and reduced overall treatment related anxiety in the video group22.

Purpose To determine the effectiveness of the introduction of a video on patient preparedness for patients receiving a CT Scan for radiotherapy to the prostate.

Methods The project will consist of three phases: video production, experiment and data collection, and analysis and dissemination.

  1. Video production - The investigators will produce the instructional video, test the video, and revise based on initial feedback. Christopher Townsend and Sunnybrook Media will produce the video using the script written by Agnes Ryzynski, with input from team members. The script will highlight the importance of rectal and bladder preparation prior and during the planning CT scans. Images will be presented showing both normal and abnormal preparation examples, instructing patients how to prepare for the planning CT scan. The video will be tested by patients and radiation oncologists, nurses and radiation therapists prior to launch.
  2. Experiment and data collection - The investigators will use a control experimental group design. The RA will recruit sixty participants at their pre-planning appointment date or via telephone. The RA will present the study rationale; those who agree to participate will sign the study consent, and be assigned a study entry number. Participants will be randomly assigned to either the control group or the experimental group. The sample size was calculated based on the observed proportion of patients needed to be rescanned: 0.76 (42/55). To have a treatment group with a proportion of 0.38 who needed to be rescanned, a 50% decrease, the investigators will need at least 25 patients in each group to have a power of 0.8, given a 0.05 significance level. To account for study attrition (no more than 20% loss of participants), the investigators will require 30 subjects per group to observe a large treatment effect (e.g. 50% decreases in the proportion of rescanning).
  3. Data analysis and dissemination - A statistical analysis will be conducted on the patient preparedness data. The investigators will conduct quantitative analysis of the evaluations form using a Likert scale. Patients' evaluations will also contain open ended questions to capture patients' comments about their experiences during the study. The investigators will analyze the details about patients' and radiation therapists' satisfaction and patients' knowledge about the video content.

Confidentiality Patient confidentiality will be assured. All patients will have assigned a study number and their names will not be disclosed at any time. All study data will be kept in a locked cabinet, that only the investigators have access to.

研究类型

介入性

注册 (实际的)

58

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Ontario
      • Toronto、Ontario、加拿大、M4K 3M8
        • Odette Cancer Centre, Sunnybrook Health Sciences Centre

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

男性

描述

Inclusion Criteria:

  1. 18 years of age or older
  2. All patients who are referred for planning simulation for prostate cancer IMRT will be invited to participate
  3. Patients who speak and read English will be invited to participate.
  4. Have the ability to complete the questionnaire.

Exclusion Criteria:

  1. Non- English speaking patients.
  2. Patients who refuse consent.
  3. Patients who are confused or who are cognitively unable to complete the questionnaire.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:支持治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:Experimental group
Patients will receive the standard are to prepare them for their planning CT scan. They will be presented with the flyer that will be developed based on information about the importance of rectal and bladder preparation that is currently provided to patients and will also watch a youtube video on how to prepare for their CT simulation appointment. A few days before the CT planning appointment, patients in this group will be called by the radiation therapist or RA, reminding them about the rectal preparation for the appointment. Each patient will also be reminded to watch the instructional video on YouTube. Patients will be asked not to share the video link with other patients during the study.
Patients in the control group will receive standard patient education Patients in the experimental group will receive standard education and an educational video
无干预:Control group
Patients in this group will receive the standard care to prepare them for their planning CT scan. They will be presented with the flyer at the consultation. A few days before the CT appointment, patients in this group will also be called and reminded about the required preparations, but will not be told about the video. In addition to the statistics about patient preparedness collected by the radiation therapist conducting the CT scan and stored and secured in an OCC Pinnacle planning system, we will also evaluate: patients' satisfaction with the preparation instructions, their knowledge (knowledge questionnaire) about the video content and importance of understanding the rectal emptying procedures, and radiation therapists' satisfaction with patients' rectal preparation.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Number of Participants Whom Had Proper Preparation After Education Intervention
大体时间:1 month (patients will be followed until their treatment is complete)
patients will receive a questionnaire to assess their satisfaction of their appointment. CT scans will be assessed for compliance of preparation based on departmental guidelines and rescans required.
1 month (patients will be followed until their treatment is complete)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Ewa Szumacher, FRCP(C), Med、Sunnybrook Health Sciences Centre

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2015年7月1日

初级完成 (实际的)

2016年3月1日

研究完成 (实际的)

2016年6月1日

研究注册日期

首次提交

2015年3月30日

首先提交符合 QC 标准的

2015年4月1日

首次发布 (估计)

2015年4月7日

研究记录更新

最后更新发布 (实际的)

2017年2月20日

上次提交的符合 QC 标准的更新

2016年12月28日

最后验证

2016年12月1日

更多信息

与本研究相关的术语

其他研究编号

  • Sunnybrook ID 123

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

在美国制造并从美国出口的产品

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