NCT01228773Unknown2 期
The Efficacy of Web-based, Tailored Program(Health Navigation®) for the Management of Cancer-Related Fatigue in Cancer Survivors
适应症
试验速览
- 阶段
- 2 期
- 入组人数
- 266
- 试验地点
- 1
- 主要终点
- Score of fatigue Severity
研究概览
简要总结
The objective of this study is
- to develop a web-based, tailored program for Cancer-related fatigue in cancer survivors, which is comprehensive and evidence-based,
- to evaluate the efficacy for cancer-related fatigue as a result of participating in the Web based, tailored program(Health Navigation®) for 12 weeks
- to evaluate the efficacy for quality of life, fatigue-related behavior, satisfaction with the treatment as a result of participating in the Web based, tailored program(health navigation®) for 12 weeks
- to assess the efficacy of such intervention compared with usual care in cancer survivors
详细描述
*** Background
Cancer-related fatigue (CRF) and its impact on patients' quality of life has been increasing subject of research. Especially, cancer survivors who are complaining of fatigue (moderate - severe) should be cared.
Multidimensional characteristics of CRF were addressed in the NCCN guideline for CRF, and NCCN guideline points out the importance of behavioral approaches in managing of CRF.
NCCN guideline in 2008 suggests that 6 strategic areas (1) Energy Conservation, 2) Pain 3) Sleep disturbance 4) Distress 5) exercise, 6) Nutrition) are important issues in caring CRF in addition to the medical treatment caring chronic disease or co morbidity.
Behavioral strategy can lead those 6 areas to be effective.
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
- None
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult (≥20, ≤65)
- •moderate to severe fatigue (fatigue VAS ≥4), which persists at least 1 week in the Average Fatigue or the the Worst Fatigue
- •Stage I-III
- •Within 24 months of completion of primary treatment with curative intent (Surgery, radiotherapy, chemotherapy)
- •Cancer survivors who are familiar with the high-speed internet and mobile phone, or cancer survivors who can participate in the web-based program with their supporter's assistance.
排除标准
- •patients undergoing or planning surgery, radiation therapy or chemotherapy
- •Major health problem which might cause fatigue or in which exercise/nutrition intervention is contraindicated at the discretion of clinician; from PAR-Q and ACSM test, cardiovascular disease(congestive heart failure, angina), pulmonary disease(chronic obstructive pulmonary disease, restrictive pulmonary disease), uncontrolled hypertension, poorly controlled diabetes and severe musculoskeletal disease and so on
- •Sign of infection (body temperature ≥ 37.2℃, WBC≥11,000)
- •Thrombocytopenia (platelet count ≤ 100,000/mcl)
- •Anemia (Hb ≤ 10g/dL)
- •SGOT or SGPT > 40 IU/L
- •Creatinine > 1.4 mg/dL
- •severe psychiatric disorders (psychotic disorder, major depression and so on) or suicidal tendencies
- •evidence of metastasis and recurrence
- •ECOG(Eastern Cooperative Oncology Group) performance status of 3-4
- •Not Korean speaking
- •Not understanding of the study purpose and not written informed consent
结局指标
主要结局
Score of fatigue Severity
时间窗: 24 weeks
BFI and FSS
次要结局
- Mean scores of symptom scores(24 weeks)
- Scores of EORTC QLQ-C30(24 weeks)
- stage of readiness(24 weeks)
研究者
研究点 (1)
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