La Tour Hospital
Meyrin, Canton of Geneva, 1217, Switzerland
NCT Number: NCT07283627
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).
Interested in participating?
Request Info18 year and older
All sexes
Observational
Meyrin, Canton of Geneva, 1217, Switzerland
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.
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.
According to Art.7 HRO this research project falls under Risk Category A, as the only procedure deviating from routine practice is the collection of standardized PROMs.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 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.
Time frame: From enrollment to the end of treatment at (approximately) 8 weeks
The secondary variable of interest is the HADS total score, also measured at the start and end of treatment. The HADS total score ranges from 0 to 42, with higher scores indicating greater psychological distress. Similarly, this outcome was chosen as it is widely used in cancer research and its accuracy has been proven.
La Tour Hospital
Other
Acronym: MBT & cancer
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