Clinical Effectiveness Assessment of Integrated Chinese and Western Therapy for Cancer-Related Fatigue
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Change in Cancer-Related Fatigue (CRF) Score (0-10)
研究概览
简要总结
Cancer-related fatigue (CRF) is a common and debilitating symptom in patients with cancer. Evidence-based non-pharmacological approaches include sleep hygiene, physical activity, nutritional management, and traditional Chinese medicine (TCM). This study evaluates the clinical effectiveness of an interdisciplinary holistic program integrating Chinese and Western therapies for CRF among hospitalized cancer patients receiving integrated care. Approximately 100 participants will be enrolled and followed for up to 3 months.
详细描述
Eligible hospitalized cancer patients receiving integrated Chinese and Western care will be enrolled after providing informed consent. Participants will complete a CRF questionnaire and receive a non-invasive holistic integrative care program, including patient education, sleep hygiene, exercise guidance, nutritional assessment/intervention, and TCM-related care. The primary endpoint is change in CRF score. Secondary endpoints include TCM constitution assessment, vital signs, anthropometrics, complete blood count, and liver/renal function tests. Participants will be followed for 3 months from enrollment.
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
- 20 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion Criteria:
- •Signed informed consent form.
- •Age 20 to 95 years.
- •Receiving integrated Chinese and Western holistic care.
- •Agree to provide clinically relevant data for this study.
排除标准
- •Refuse to continue participation during the study period, or the family requests discontinuation (withdrawal).
- •Psychiatric disorder that makes the participant unable to cooperate.
- •Exclusion Criteria:
研究组 & 干预措施
Integrated Chinese and Western Holistic Care
All participants receive an integrated Chinese and Western holistic care program during hospitalization for cancer-related fatigue management. The program includes routine fatigue assessment and individualized supportive care measures (education, sleep hygiene, exercise encouragement, aromatherapy and/or massage, nutrition consultation, and shared decision-making). Traditional Chinese Medicine consultation (e.g., acupuncture and/or Chinese herbal medicine) may be provided when clinically indicated.
干预措施: Integrated Chinese and Western Holistic Care Program (Other)
结局指标
主要结局
Change in Cancer-Related Fatigue (CRF) Score (0-10)
时间窗: From admission (baseline) through discharge (last in-hospital assessment; up to 30 days)
CRF is assessed using the Taiwan Society of Cancer Palliative Medicine fatigue scale (0-10) during hospitalization. Peak CRF score is defined as the maximum recorded CRF score from admission to discharge. Discharge CRF score is defined as the last in-hospital CRF assessment prior to discharge. The primary outcome is the within-participant change in CRF score from peak to discharge.
次要结局
- Proportion of Participants With Moderate-to-Profound CRF at Discharge (CRF Score ≥4)(At discharge (last in-hospital assessment; up to 30 days after admission))
- Distribution of CRF Severity Categories at Discharge (0, 1-3, 4-6, 7-8, 9-10)(At discharge (last in-hospital assessment; up to 30 days after admission))
研究者
Chia-Ying Chuang
Attending Physician
Taichung Tzu Chi Hospital