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临床试验/NCT02863302
NCT02863302Unknown不适用

Reflexology Treatment for Newly Diagnosed AML Patients, Can it Reduce GI Tract Side Effects, and Improve and Improve Patients Mood.

Rambam Health Care Campus2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2017年1月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
50
试验地点
2
主要终点
Change from baseline in the FACIT-D questionaire.

研究概览

简要总结

The aim of this study is to test a complementary therapy intervention (reflexology) that will assist in improving quality of life (QOL) for patients undergoing chemotherapy for acute myeloid leukemia. within the context of conventional medical care. Quality of life will be assessed via intermediate indicators: 1) physical indicators (greater physical functioning, lower presence of symptoms) 2) emotional indicators (greater spirituality, lower anxiety, and lower depressive symptomology); by a specific questionnaire. 3) chemotherapy side effects associated with the digestive system.

详细描述

The goal of this study is to test a complementary therapy intervention that will assist in improving quality of life (QOL) for patients undergoing chemotherapy for acute myeloid leukemia within the context of conventional medical care. This open study will test a one group design in which participants will continue to receive conventional care. All patients will receive reflexology (a specialized foot therapy) from a certified reflexologist twice weekly from the beginning of chemotherapy treatment.

The specific aims are: 1) to evaluate the effect of reflexology treatment on chemotherapy side effects effecting the digestive system. 2) to evaluate the effect of reflexology treatment on Quality of life. The assessment of the treatment will be executed on the FACIT-D VERSION 3.The influences of the treatment will also be evaluated by the nursing staff, in order to describe the patient's mental health and the condition of his intestinal movement.The side effect before during and after the chemotherapy treatment will be compared using the questionnaire.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
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

入选标准

  • diagnosis of AML
  • chemotherapy treatment
  • signing a consent form.

排除标准

  • Not willing to sign a consent form.

结局指标

主要结局

Change from baseline in the FACIT-D questionaire.

时间窗: Change from baseline in the FACIT-D questionaire at 1,2,3, and 4 weeks from the beginning of chemotherapy treatment.

次要结局

  • To evaluate the effect of reflexology treatment on chemotherapy associated diarrhea(Diarrhea frequency will be recorded daily from the first day of chemotherapy and up to 30 days.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Netanel Horowitz MD

Head of ambulatory unit , hematology division

Rambam Health Care Campus

研究点 (2)

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