Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2025-12-26 @ 4:11 AM
Study NCT ID:
NCT07283627
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-12-24
First Post:
2025-12-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Exploring the Evolution of Quality of Life and Emotional Distress Among Cancer Patients Participating in Mind-body Therapies
Sponsor:
La Tour Hospital
Organization:
Study Overview
Official Title:
Exploring the Evolution of Quality of Life and Emotional Distress Among Cancer Patients Participating in Mind-body Therapies
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MBT & cancer
Brief Summary:
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).
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).
Detailed Description:
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.
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.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: