The Immediate Effect of Mindfulness-Based Supportive Therapy (MBST) vs Supportive Listening on Palliating Suffering in Palliative Care Cancer Patients: A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 68
- 试验地点
- 2
- 主要终点
- Patient's perception of practitioner empathic engagement measured with the Jefferson Scale of Patient's Perceptions of Physician Empathy
研究概览
简要总结
The was a parallel group, single-blinded, randomized controlled trial comparing the effectiveness of 30-minute mindfulness-based supportive therapy versus supportive listening in reducing suffering among patients with cancer. This study was conducted in the University Malaya Medical Centre, from 1st august 2020 to 31 December 2020.
详细描述
This study was conducted in the University Malaya Medical Centre. The study design was a parallel-group, single-blinded, randomized controlled trial. The trial will be registered at the Clinical Trials registry and was conducted in accordance to the Declaration of Helsinki. The investigators recruited patients by screening patients under the care of the palliative care team at University Malaya Medical Centre. Patients fulfilling the inclusion and exclusion criteria will be approached and included in the study if give informed consent to participate.
Inclusion criteria:
- Stage III and IV cancer patients aged 18 years and above
- The overall suffering score of 4/10 and above based on The Suffering Pictogram
Exclusion criteria:
- Patients who are confused based on The Confusion Assessment scoring
- Patients who are non-communicative verbally
- Patients with psychiatric illness
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stage III and IV cancer patients aged 18 years and above
- •The overall suffering score of 4/10 and above based on The Suffering Pictogram
排除标准
- •Patients who are confused based on The Confusion Assessment scoring (CAM)
- •Patients who are non-communicative verbally
- •Patients with psychiatric illness
结局指标
主要结局
Patient's perception of practitioner empathic engagement measured with the Jefferson Scale of Patient's Perceptions of Physician Empathy
时间窗: 30-minute
Jefferson Scale of Patient's Perceptions of Physician Empathy is a 5-item instrument (range from 1 to 5, with higher scores reflecting a greater degree of physician's empathy).
Psychological distress examined using the Hospital Anxiety and Depression Scale.
时间窗: 30-minute
Hospital Anxiety and Depression Scale consists of 14 items rated on a Likert scale yielding a score of total score (0-42), an anxiety score (0-21) and a depression score (0-21), with higher score reflecting higher distress.
Suffering measured using the Suffering Pictogram.
时间窗: 30-minute
Suffering pictogram is in numerical scale of 0 to 10 (0 = no suffering, 10 = worst possible suffering). The pictogram contains eight items rated on a Likert scale - discomfort, worry, fear, anger, sadness, hopelessness, difficulty in acceptance and emptiness. The total suffering score of the eight items ranges from 0 to 32, with higher score reflecting more suffering.
Quality of life assessed by the Functional Assessment of Chronic Illness Therapy.
时间窗: 30-minute
Functional Assessment of Chronic Illness Therapy, contains 39 items (range from 0 to 4, with higher scores reflecting higher quality of life) forming an overall total score and five subscales scores: physical, social, emotional, functional and spiritual.
次要结局
- Perception of stress measured by Perceived Stress Scale(30-minute)
- Mindfulness measured by Frieburg Mindfulness Inventory(30-minute)