The Effect of Progressive Relaxation Exercise on Caregiver Burden, Fatigue and Quality of Life in Caregivers of Patients With Advanced Cancer: Randomized Controlled Clinical Study
试验速览
- 阶段
- 不适用
- 入组人数
- 64
- 主要终点
- Change in fatigue severity
研究概览
简要总结
Caregivers of patients with advanced cancer will be entered. Participants will be randomized to one of two study arms: Arm 1: Progressive muscle relaxation; Arm 2: Attention matched control. Hypothesis: Progressive muscle relaxation will decrease caregiving burden and severity of fatigue and improve quality of life.
详细描述
Previous reports have revealed that progressive muscle relaxation to use to decrease symptom burden associated with cancer. However, there have been limited studies that directly focus on supporting caregivers of advanced cancer patients who face serious problems in diagnosis and treatment process, at least as much as cancer patients. Besides, till date, no study has been conducted to determine the effects of progressive relaxation exercise on caregiver burden, fatigue and quality of life in those providing care for patients with advanced cancer. The present study investigates the effects of progressive muscle relaxation in a single-site, 2-arm, randomized, controlled study of 64 caregivers of patients with advanced cancer. Arm 1: relaxation; Arm 2: Attention matched control. The investigators hypothesize that progressive muscle relaxation will decrease severity of caregiver burden and fatigue and improve quality of life.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Providing care for advanced cancer patients (stage III-IV) for at least 6 months
- •Primary caregiver (caring for the longest time)
- •No communication problem
- •Not using any other non-pharmacological approach during the study period
排除标准
- •Providing care for individuals with early-stage (Stage I-II) cancer
- •Caregivers who providing care services for a fee
- •Having a history of psychiatric disorder (major depression, etc.)
- •Not willing to participate in the study
结局指标
主要结局
Change in fatigue severity
时间窗: Baseline measurements, at the end of 8th week and two weeks after the completion of the interventions
Fatigue severity will be measured based on patient report by the Fatigue Severity Scale. Minimum scores indicate better level of fatigue.
Change in Quality of life status
时间窗: Baseline measurements, at the end of 8th week and two weeks after the completion of the interventions
Quality of life will be measured by the Caregiver's Quality of Life Index-Cancer Scale. Maximum scores indicate better quality of life.
Change in caregiver burden severity
时间窗: Baseline measurements, at the end of 8th week and two weeks after the completion of the interventions
Caregiver burden severity will be measured based on patient report by Experience-Based Caregiver Burden Scale in Advanced Cancer. Maximum scores indicate worse caregiver burden.
次要结局
未报告次要终点
研究者
Merve Gulbahar
Research Assistant
Hacettepe University