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临床试验/NCT02422329
NCT02422329已完成不适用

Changes in Patient Reported Constipation Among Advanced Cancer Patients After Receiving an Educational Intervention

M.D. Anderson Cancer Center1 个研究点 分布在 1 个国家目标入组 59 人开始时间: 2015年4月30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
59
试验地点
1
主要终点
Patient-Reported Perception of Constipation

研究概览

简要总结

The goal of this research study is to learn how patients' think about constipation before and after receiving education about the subject.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
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

  • •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

排除标准

  • •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

研究组 & 干预措施

Educational Video

Experimental

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.

干预措施: Questionnaires (Behavioral)

Educational Video

Experimental

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.

干预措施: Video (Behavioral)

Fact Sheet

Experimental

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.

干预措施: Questionnaires (Behavioral)

Fact Sheet

Experimental

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.

干预措施: Fact Sheet (Behavioral)

结局指标

主要结局

Patient-Reported Perception of Constipation

时间窗: 1 day

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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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