Effects of Complementary and Alternative Medicine on Mental Health in Breast Cancer Patients and Their Family Caregivers
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- Mental Health
研究概览
简要总结
During cancer treatment, several patient experience substantial psychological distress, mainly depression and anxiety, which can persist over years after completion of treatment.
Complementary and alternative medicine (CAM) has been in use among cancer patients for a long time and several types of CAM that are practiced in various parts of the world.
However, the effectiveness of different CAM therapies on mental health is still limited.
Therefore, the investigators want to assess the effectiveness of complementary and alternative medicine (CAM) (Dance/movement therapy, Art Therapy, Music Therapy, Bibliotherapy and Physical Activity) on mental health of cancer patients as well as their caregiver
详细描述
During cancer treatment, several patient experience substantial psychological distress, mainly depression and anxiety, which can persist over years after completion of treatment. These psychological impairments can aggravate symptom burden and can seriously affect health-related quality of life. Likewise, the diagnosis of cancer has not only a significant impact on the affected patients, but also on their families, and may cause emotional responses of shock, doubt, anxiety, and depression.
Complementary and alternative medicine (CAM) has been in use among cancer patients for a long time and several types of CAM that are practiced in various parts of the world. In the general among Lithuanian adult population, the use of CAM begins to seem common and the country claim for guidelines researches and to test the effectiveness of this practice to support the use of some CAM therapies on mental health of patients as well as their families.
In the St. Francis Oncology Center in Klaipeda some CAM have been applied aimed to increase the recovery and quality of life in the patients and their families. The effectiveness of different CAM therapies (Dance/movement therapy, Art Therapy, Music Therapy, Bibliotherapy and Physical Activity ) on mental health and recovery of cancer patients as well as on caregiving experiences and mental health of partners of cancer patients, it will be of great value to improve and provide a more effective service and the quality of caring in this patient as well as the continuing work of the Francis Oncology Center in Klaipeda and partners, with more higher scientific excellence and quality .
Objectives
· To assess the effectiveness of complementary and alternative medicine (CAM) (Dance/movement therapy, Art Therapy, Music Therapy, Bibliotherapy and Physical Activity) on mental health of cancer patients as well as their caregiver.
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
- Triple (Care Provider, Investigator, Outcomes Assessor)
盲法说明
The participants will be randomized
入排标准
- 年龄范围
- 18 Years 至 99 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- All adult woman with breast cancer diagnoses and their primary family caregiver
排除标准
- •Insufficient physical capacity
- •Severe mental disorder
- •Inability ti give informed consent
结局指标
主要结局
Mental Health
时间窗: Mental health (score)changes over 4 weeks intervention
Questionnaire to assess mental health
Quality of Life
时间窗: Quality of life changes (score) over 4 weeks intervention
Questionnaire to assess quality of life
次要结局
未报告次要终点
研究者
Cesar Agostinis-Sobrinho
Principal Investigator
Klaipėda University
