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临床试验/NCT06183164
NCT06183164已完成不适用

The Effect of Awareness-Based Stress Reduction Program Applied to Breast Cancer Patients Receiving Chemotherapy on Symptom Management Psychological Resilience and Quality of Life

Firat University2 个研究点 分布在 2 个国家目标入组 60 人开始时间: 2023年10月29日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
2
主要终点
ESTO SYMPTOM DIAGNOSIS SCALE

研究概览

简要总结

Implementation of awareness-based stress reduction program in breast cancer patients receiving chemotherapy and examining its effects on psychological resilience, symptom management and quality of life.

详细描述

The conscious awareness-based stress reduction program is a program that lasts eight weeks, each session lasting 2-2.5 hours and including a 6-hour silence day. In order to apply the mindfulness stress reduction program to the experimental group, the 'Conscious Awareness Stress Reduction Program day and time were determined for 30 breast cancer patients receiving chemotherapy who met the inclusion criteria and were sampled. It was applied to the patients in the experimental group, once a week for 150 minutes, lasting 8 weeks, and consisting of 8 times in total. Then, an intermediate test was applied to the patients. After the interim test, patients were asked to repeat the It applications individually for 8 weeks (between weeks 8-16). In addition, after It was applied to the patients in the experimental group by the researcher, the 'Conscious Awareness Stress Reduction Program booklet prepared by the researcher was given to the patients in order to provide a guide for the patients in the experimental group. During the implementation of the research, no intervention was applied to the control group.

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
Single (Participant)

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

  • Being over 18 years of age
  • Ability to communicate adequately
  • No psychiatric problems
  • Implementation of the Awareness-Based Stress Reduction Program is an obstacle
  • Volunteering to participate in the research

排除标准

  • Those who have communication problems
  • Those with psychiatric problems
  • Not agreeing to participate in the study.

结局指标

主要结局

ESTO SYMPTOM DIAGNOSIS SCALE

时间窗: At the end of Sessions 16 ( each Session 1 days a week)

The scale includes problems such as pain, fatigue, nausea, sadness, anxiety, insomnia, loss of appetite, feeling of well-being and shortness of breath. The severity of each symptom is evaluated with numerical scores from 0 to 10. The most important rule in evaluating the symptom is that the patient marks the number indicating the severity of the symptom according to his/her own statement. The patient is asked to match the symptoms he/she experiences with a number between 0-10 that he/she thinks best fits him/her. A score of 0 on the scale indicates that there is no symptom, while a score of 10 indicates that the symptom is experienced very severely.

Brief Psychological Resilience Scale

时间窗: At the end of Sessions 16 ( each Session 1 days a week)

It is a 5-point Likert type, 6-item, self-report measurement tool. It has an answer key of "Not at all appropriate" (1), "Not Applicable" (2), "Somewhat Appropriate" (3), "Appropriate" (4), "Completely Appropriate". Items 2, 4, and 6 in the scale are reverse coded. High scores obtained after translating the reverse coded items indicate a high level of psychological resilience.

EORTC QLQ-C 30 Quality of Life Scale

时间窗: At the end of Sessions 16 ( each Session 1 days a week)

It consists of 30 questions with three subscales: general well-being (questions 29, 30), functional difficulties (questions 1-7, 20-27) and symptom control (questions 8-19 and 28). The first 28 items in the scale are four-point Likert. Not at all: 1, A little: 2, Quite a bit: 3, A lot: 4 points. These items are questions regarding symptoms and functional domain. Low scores on these items indicate high quality of life, while high scores indicate low quality of life.

次要结局

未报告次要终点

研究者

发起方
Firat University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Gülcan Bahçecioğlu Turan

Principal Investigator

Firat University

研究点 (2)

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