跳至主要内容
临床试验/CTRI/2021/06/034218
CTRI/2021/06/034218已完成不适用

Effectiveness of a multicomponent intervention on symptom burden duringchemotherapy

MIMS College of Nursing1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2021年6月14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
32
试验地点
1
主要终点
Symptom burden

研究概览

简要总结

The aim of the study is to assess the effectiveness of a Multicomponent intervention on symptom burden in cancer patients receiving chemotherapy. Based on randomization ,intervention  group will get multicomponent intervention(Progressive muscle relaxation , guided imagery and Information Booklet) and control group will receive usual care. Informed consent will be obtained before data collection .Baseline assessment of symptom burden will be done using Edmonton  Symptom Assessment Scale at day 1 of 1st cycle of chemotherapy and intervention group will get intervention.3rd week and 6th week reassessment of symptom burden will be done. Data will be analyzed by descriptive and inferential statistics.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 85.00 Year(s)(—)
性别
All

入选标准

  • Aged 18 years or older.
  • Diagnosed with stage 1 to stage 3 of Breast and Colorectal cancer Starting their first treatment with IV chemotherapy requiring outpatient hospital visits Willing to participate in the study and give voluntary consent.
  • Able to speak, read and write in Malayalam.

排除标准

  • Metastatic cases Undergoing concurrent radiation and hormonal treatment.
  • Having severe cognitive/emotional issues as determined by the patient’s treating oncologist.
  • Already received chemotherapy for their malignancy.

结局指标

主要结局

Symptom burden

时间窗: 3 time points | Baseline (day 1 of 1st Cycle) | 3rd week of chemotherapy | 6th week of chemotherapy

次要结局

未报告次要终点

研究者

发起方
MIMS College of Nursing
申办方类型
Research institution

研究点 (1)

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