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临床试验/CTRI/2019/06/019519
CTRI/2019/06/019519已完成不适用

A study to assess the effectiveness of information booklet on prevention of hand foot syndrome in breast cancer patients receiving fluorouracil and capecitabine

No sponser1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2014年2月6日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
80
试验地点
1
主要终点
Prevention of Hand foot syndrome

研究概览

简要总结

Aim of the study: To assess the effectiveness of information booklet on improving knowledge and prevention of hand and foot syndrome in Cancer patients receiving fluorouracil and Capecitabine.

Materials and methods: This prospective randomized control trial included 81 patients from Day care unit and outpatient department, IRCH AIIMS, New Delhi during the period of June to December 2014.  All the patients meeting inclusion criteria were randomly assigned to experimental group (n=40) and control group (n=41). The demographic and clinical profile of patients were collected from both the groups. The pre –test was done before intervention with knowledge questionnaire to assess knowledge and checklist to assess the sign and symptoms of Hand foot syndrome. Patients in experimental group received information booklet along with short discussion on the content of the Booklet. Control group received standard routine care. Post-test was collected on 22nd day using the same tools for both the groups. Data was analyzed using STATA 12.1. All the patients recruited in the study were analyzed at the end and intention to treat analysis was done. Parametric test were applied for the test.

Results: A total of 81 patients participated in the study with 40 patients in experimental and 41 in the control group and 31patients from each group completed the study. The two groups were comparable at baseline regarding demographic variables and clinical profile except in duration of treatment which was >6 months in control group as compared to experimental group. Most of the subjects (59.3%) had poor knowledge regarding Hand foot syndrome at baseline (pre-test). There was statistically significant increase in knowledge from pre-test to post-test in both the groups but knowledge gain in experimental group  was higher as compared to control group at (p<0.001). Hand foot syndrome grades (grade 0, 1) in experimental and control group were comparable at baseline. Majority of patients 95% in experimental and 92% in control group hand foot syndrome grades remained unchanged from pre-test to post-test and both the groups were comparable at p>0.05. There was no statistically significant association between knowledge with selected demographic and clinical variables. However, there was statistically significant association of knowledge with hand foot syndrome grades. Patients with grade 1 hand foot syndrome had higher knowledge as compared to those without symptoms (grade 0) at (p=0.003).

Conclusion: Administration of Information booklet significantly increase the knowledge regarding HFS whereas there was no change with regard to prevention of Hand foot syndrome in cancer patients receiving fluorouracil and capecitabine. However, effectiveness of information booklet in prevention of hand foot syndrome can to be tested on larger sample size with repeated follow up.

研究设计

研究类型
Interventional
分配方式
Random Number Table
盲法
Not Applicable

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • Adult male or female diagnosed with cancer and were recieving 5FU or capecitabine Who could read Hindi or english.

排除标准

  • Who were not willing to participate in the study.
  • Who cannot read Hindi or English.

结局指标

主要结局

Prevention of Hand foot syndrome

时间窗: 3 weeks after intervention

Increase in knowledge

时间窗: 3 weeks after intervention

次要结局

  • Association of knowledge with hand foot syndrome(at baseline and 21 days after intervention)

研究者

发起方
No sponser
申办方类型
Other [No sponser]

研究点 (1)

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