Changes in Patient Reported Constipation Among Advanced Cancer Patients After Receiving an Educational Intervention
研究概览
详细说明
If participant agrees to take part in the study, information about them (such as their age, gender, ethnicity, religion, diagnosis, and drugs they are currently taking) will be collected from their medical record.
Participant will also complete 1 questionnaire about constipation. It should take about 1-3 minutes to complete the questionnaire.
After completing the questionnaire, participant will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups. This is done because no one knows if one study group is better, the same, or worse than the other group. Participant will have an equal chance of being in either group.
- If participant is assigned to Group 1, they will watch a short educational video.
- If participant is assigned to Group 2, they will read a fact sheet.
Both the video and the fact sheet describe symptoms of constipation and the importance of regular bowel movements. They should take about 3 minutes each to complete.
After participant has viewed the educational material, they will complete 3 questionnaires about constipation and how helpful they think the video or fact sheet was in educating them about constipation. It should take about 10 minutes total to complete these questionnaires. Participant will watch the video/read the fact sheet and complete the questionnaires in their room at the Supportive Care Clinic.
Length of Study:
Patient's participation on this study will be over after they have completed the last 3 questionnaires.
This is an investigational study.
Up to 200 participants will be enrolled in the study. All will take part at MD Anderson.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Texas
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Houston、Texas、美国、77030
- University of Texas MD Anderson Cancer Center
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Patients with diagnosis of advanced cancer, including recurrent, locally advanced, or metastatic cancer
- Age >/= 18 years old
- Patients must be able to understand, read, write, and speak English
- Patients must have no clinical evidence of cognitive impairment as determined by the palliative care physician (Memorial Delirium Assessment Score >/= 7)
- Patients must sign an informed consent
Exclusion Criteria:
- Patients with a diagnosis of inflammatory bowel disease, i.e. Crohn's disease or ulcerative colitis
- Patients with complete or partial bowel obstruction as determined by the palliative care physician
- Patients with a bowel ostomy
学习计划
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：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Educational Video
Participants complete self-administered numerical rating scale (NRS) constipation questionnaire at baseline.
Participants watch a 3-minute educational video describing symptoms of constipation and importance of regular bowel movements.
Participants then complete three self-administered questionnaires, post-educational material, Modified Rome III questionnaire, and Overall satisfaction of the educational material.
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Participants complete questionnaires at baseline and after intervention.
其他名称：
Participants watch a 3-minute educational video describing symptoms of constipation and importance of regular bowel movements.
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实验性的：Fact Sheet
Participants complete self-administered numerical rating scale (NRS) constipation questionnaire at baseline.
Participants read educational material describing symptoms of constipation and importance of regular bowel movements.
Participants then complete three self-administered questionnaires, post-educational material, Modified Rome III questionnaire, and Overall satisfaction of the educational material.
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Participants complete questionnaires at baseline and after intervention.
其他名称：
Participants read educational material describing symptoms of constipation and importance of regular bowel movements.
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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 |
|---|---|---|
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Patient-Reported Perception of Constipation
大体时间：1 day
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Primary objective is to examine effect of educational intervention on the patient-reported perception of constipation (PRC, by a 0-10 numeric rating score) among advanced cancer patients.
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1 day
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合作者和调查者
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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