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临床试验/NCT04822220
NCT04822220已完成不适用

The Effect of Self-Management Program Based on the Individual and Family Self-management Theory on Fatigue, Daily Life Activities and Wellness on Cancer Patients

Akdeniz University1 个研究点 分布在 1 个国家目标入组 94 人开始时间: 2020年11月15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
94
试验地点
1
主要终点
Change From Baseline in fatigue on the Brief Fatigue Inventory at week 8

研究概览

简要总结

The purpose of this study is to evaluate the effect of Self-Management Program based on the Individual and Family Self-management Theory on fatigue, daily living activities and well-being of cancer patients.

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
否

入选标准

  • •Inpatients for symptom management or supportive care in oncology wards
  • •Patients who were at first two days of hospitalization
  • •Patients who had score of 3≤ or ≤7 in Fatigue Visual Analogue Scale (VAS)
  • •Patients who had score of ≤5 in Pain Analog Visual Scale (VAS)
  • •Patients who had score of ≤5 The Modified Borg Scale
  • •Patients who had score of 0, 1, 2 or 3 in ECOG Performance scale
  • •Patients who had metastases
  • •Patients who were over 18 years of age
  • •Patients who had orientation of person, place and time
  • •Patients who had no communication barriers
  • •Patients who agreed to participate in the study

排除标准

  • •Patients who had hospitalized for the purpose of receiving chemotherapy
  • •Patients whose Hb value was ≤8 g / dl
  • •Patients whose body temperature ≥ 38.5 ° C within the last 24 hours
  • •Patients who had diarrhea in the last 24 hours (frequency of defecation ≥ 3 / day)
  • •Patients who had a score of ≤ 16 kg / m2 in Body Mass Index (BMI)
  • •Patients who had advanced heart failure
  • •Patients who had untreated hypothyroidism
  • •Patients who diagnosed with major depression and / or treated for depression
  • •Patients who had no family member involved in their care

研究组 & 干预措施

Experimental

Experimental

Fatigue Self-management Programme

干预措施: Fatigue Self-management Programme (Other)

Controlled

No Intervention

The control group received routine treatment and nursing care

结局指标

主要结局

Change From Baseline in fatigue on the Brief Fatigue Inventory at week 8

时间窗: Baseline, 2 week, 4 week, 8 week

The Brief Fatigue Inventory is a validated, self reported instrument assessing average fatigue.

次要结局

  • Change From Baseline in daily living activities on the Katz Index of Independence at week 8(Baseline, 2 week, 4 week, 8 week)
  • Change From Baseline in well-being on Well-Being Questionnaire (22 items) (W-BQ22) at week 8(Baseline, 2 week, 4 week, 8 week)

研究者

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

Zeynep KARAKUŞ

Research Assistant

Akdeniz University

研究点 (1)

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