跳至主要内容
临床试验/NCT07283627
NCT07283627Enrolling By Invitation不适用

Exploring the Evolution of Quality of Life and Emotional Distress Among Cancer Patients Participating in Mind-body Therapies

La Tour Hospital1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2025年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
150
试验地点
1
主要终点
Quality of life

研究概览

简要总结

Cancer incidence is increasing worldwide, and although survival rates have improved thanks to advances in treatment and early detection, many patients continue to experience reduced quality of life (QoL), anxiety, depression, and distress. Mind-body therapies (MBTs)-including mindfulness, laughter yoga, and art therapy-are increasingly integrated into supportive oncology care. Evidence suggests these therapies may improve psychosocial well-being; however, existing research often suffers from methodological limitations, small samples, and limited generalizability.

The OTIUM centers in Geneva and Meyrin offer structured MBT programs to cancer patients. This project aims to evaluate the evolution of QoL and emotional distress in patients participating in one of these therapies, using validated patient-reported outcome measures (PROMs).

详细描述

Cancer is one of the leading causes of disease burden, morbidity, and mortality worldwide. With both the aging and growth of the population, combined with overall socioeconomic development, the prominence of cancer is increasing, with an estimated annual incidence of 35 million cases projected by 2050. Advancements in early detection and treatments have improved survival rates and life expectancy, allowing individuals to live with cancer for longer periods of time. However, this life-threatening disease and its treatments may lead to a reduced quality of life (QoL), heightened anxiety, distress and depression. Patients with diagnosed cancer are 28% more likely to experience any mental disorder within a 12-month period compared to the general population (odds ratio: 1.28, 95% confidence interval (CI), 1.14-1.45). The somatic symptoms of cancer such as fatigue, pain, and loss of appetite along with the associated mental health burden, have consistently been associated with higher mortality rates.

Improved cancer survival rates have shifted attention toward the patient's symptom burden, encompassing both physical and mental aspects. Over the past two decades, this has led to the emergence of a holistic care approach. Integrative oncology, defined by the Society of Integrative Oncology, comprises mind and body therapies (MBTs), natural products, and/or lifestyle modifications. MBTs are defined as practices that "focus on the interactions among the brain, mind, body, and behavior, with the intent to use the mind to affect physical functioning and promote health", and have recently been recommended by the Society of Integrative Oncology and American Society of Clinical Oncology guidelines. Such practices comprise, among other, techniques like mindfulness, yoga, art therapy, relaxation or taichi. In this project, the investigators aim to specifically investigate three MBTs: (i) Mindfulness, (ii) Laughter Yoga, and (iii) Art therapy.

  • Mindfulness is defined as non-judgmental attention to experiences of the present moment, including thoughts, emotions, and bodily sensations.
  • Laughter yoga combines unconditional laughter with yoga breathing practices and yoga stretching poses so that patients laugh different from jokes or humor programs.
  • Art therapy is defined as "a form of psychotherapy that uses art media as its primary mode of communication".

To better understand the benefits of therapy for patients, standardized patient-reported outcome measures (PROMs) are increasingly utilized in cancer research. These tools offer valuable insights from the patient's perspective, capturing information on quality of life (QoL) as well as the status of physical, mental, and social health domains. Among the most widely used PROMs in cancer research are the Core Quality of Life Questionnaire developed by the European Organisation for Research and Treatment of Cancer (EORTC QLQ-C30) and the Hospital Anxiety and Depression Scale (HADS), although many other tools are also available. Mindfulness, Laughter Yoga and Art therapy have each proven effective in alleviating depression, anxiety, pain and other symptoms. Adoption of these practices, however, remains limited, likely due to the lack of robustness and diversity of the studies. Indeed, most studies involved a small sample size, with methodological differences in the intervention, with the bulk of the research focusing on women with breast cancer.

Therefore, the purpose of our pragmatic research is to explore and describe the evolution of quality of life and emotional distress in cancer patients participating in one of three mind-body therapies (MBTs), as measured by the EORTC QLQ-C30 and HADS.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient diagnosed with cancer
  • Acceptance and signature of an informed consent form
  • Age of majority
  • Completion of one of the therapies concerned.

排除标准

  • Withdrawal of the signed informed consent form
  • Metastatic cancer
  • Cancer recurrence
  • Drugs use against stress
  • Memory disorders
  • History or current use of a MBT

结局指标

主要结局

Quality of life

时间窗: From enrollment to the end of treatment at (approximately) 8 weeks

The primary variable of interest is the total score on the EORTC QLQ-C30, measured at baseline and at the end of treatment, on average 8 weeks after start of treatment. The EORTC QLQ-C30 is scored on a 0 to 100 scale, with higher scores indicating better quality of life for the global health status/quality of life scale. This outcome was selected because it is the most widely used PROM, which facilitates interpretation and comparison with existing literature, and enables us to better assess the quality of care we provide.

次要结局

  • Emotional distress(From enrollment to the end of treatment at (approximately) 8 weeks)

研究者

发起方
La Tour Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Anthony Pernoud

Clinical Project Manager

La Tour Hospital

研究点 (1)

Loading locations...

相似试验