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
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 94
- 试验地点
- 2
- 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
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
Zeynep KARAKUŞ
Research Assistant
Akdeniz University
研究点 (2)
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