A Psycho-educational Intervention for Symptom Cluster Management Among Cancer Patients Undergoing Chemotherapy in Vietnam
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Symptom cluster
研究概览
简要总结
The purpose of this study is to develop, implement and undertake a preliminary evaluation of a psychoeducational intervention for managing a cancer-related symptom cluster including pain, fatigue and sleep disturbance experienced by Vietnamese cancer patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Investigator)
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
- •Are diagnosed with any type of cancer
- •Are over 18 years of age
- •Have finished the second chemotherapy cycle
- •Expected prognosis of at least 12 months
- •Karnofsky level of ≥ 60/
- •Report three symptoms: fatigue, pain and sleep disturbance at severity level of equal or above 3 during the past 7 days.
- •Ability to communicate in Vietnamese
排除标准
- •Inability to complete questionnaires or participate in the intervention due to literacy level or communication impairment.
- •Have been diagnosed with major psychiatric morbidity such as suicidal tendencies or schizophrenia.
- •Involved in other clinical trials
研究组 & 干预措施
Control
Participants in the control group received standard treatment from oncologists and nurses at Hanoi Medical University Hospital.
Intervention
In addition to standard care provided by oncologists and nurses at Hanoi Medical University Hospital as described above, participants assigned to the intervention group received the psychoeducational intervention delivered by the nurse researcher.
干预措施: Psycho-educational intervention (Other)
结局指标
主要结局
Symptom cluster
时间窗: 4 weeks
The three-single item Numeric Analogue Scales (fatigue, pain and sleep disturbance) were used at baseline and 4 weeks of the intervention to assess the change of symptom severity at cluster levels. The scales consists of a number of symptoms rated on the 11-point scales, with 0 referring to "not present" and 10 referring to "as bad as you can imagine". The symptom cluster severity was evaluated by averaging symptom summary scores, with a summary higher score indicating greater symptom cluster severity.
Fatigue
时间窗: 4 weeks
The Brief Fatigue Inventory (BFI) was used to assess the change of fatigue from baseline to 4 weeks of the intervention. The BFI consists of nine items assessing severity of fatigue in the past 24 hours (4 items) and its impacts on patients' different aspects of life, such as daily activity, emotional well-being, walking ability, work, and social interactions (5 items) on a 11-point scale. A summary higher score indicating greater fatigue severity and interference.
Pain
时间窗: 4 weeks
The Brief Pain Inventory was used to assess the change of pain from baseline to 4 weeks of the intervention. The Brief Pain Inventory - Short Form (BPI) encompasses a 4-item pain severity subscale and a 7-item pain interference with daily activities subscale. Each item was rated on 11-point numerical rating scales. A summary higher score indicating greater pain severity and interference.
Sleep disturbance
时间窗: 4 weeks
The Pittsburgh Sleep Quality Index (PSQI) was used to assess patients' sleep quality and pattern at baseline and 4 weeks of the intervention. The scale consists of 19 self-reported items categorised in 7 domains, including sleep quality, duration, sleep effectiveness, sleep disturbances, sleep medication, and daytime dysfunction over the last month. Possible scores range from 0 to 21 with a higher score indicating greater sleep disturbance
次要结局
- Performance status(4 weeks)
- Depression and Anxiety(4 weeks)
- Health-related quality of life(4 weeks)
研究者
Ly Nguyen
Principal Investigator
Hanoi Medical University