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临床试验/NCT04427215
NCT04427215Unknown1 期

Effects of Complementary and Alternative Medicine on Mental Health in Breast Cancer Patients and Their Family Caregivers

Klaipėda University2 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2020年7月1日最近更新:
适应症

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

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

发起方
Klaipėda University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Cesar Agostinis-Sobrinho

Principal Investigator

Klaipėda University

研究点 (2)

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