CancerMBT & cancerNCT07283627
Exploring the Evolution of Quality of Life and Emotional Distress Among Cancer Patients Participating in Mind-body Therapies
An observational study of Cancer and Mind-Body Therapies, run by La Tour Hospital at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Mind-Body Therapies
- How many people
- 150 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Dec 2025to 1 Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study participants will be selected from individuals receiving supportive oncology services at the OTIUM Centers located in Geneva and Meyrin, Switzerland. These centers provide mind-body therapies as part of routine integrative care for adults living with or recovering from cancer. Patients typically come from the greater Geneva region and may be referred by oncologists at Hôpital de La Tour or may self-present to the centers to participate in non-pharmacological supportive programs. The study population therefore reflects a real-world clinical population engaged in mind-body therapies within an outpatient supportive care setting.
Who may be able to join
- Patient diagnosed with cancer
- Acceptance and signature of an informed consent form
- Age of majority
- Completion of one of the therapies concerned.
Who cannot join
- Withdrawal of the signed informed consent form
- Metastatic cancer
- Cancer recurrence
- Drugs use against stress
- Memory disorders
- History or current use of a MBT
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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).
Read the 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.
- Conditions
- Cancer, Mind-Body Therapies
- Keywords
- Cancer, Supportive care, Patient-reported outcomes, Emotional distress, Mind-body therapies, Quality of life, Mindfulness, Laughter yoga, Art therapy, Integrative oncology
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| OTIUM Minb-body therapy cohort | This cohort includes adult cancer patients participating in one specific mind-body therapy (MBT) offered at the OTIUM Centers in Geneva and Meyrin. Eligible participants take part in a structured program-mindfulness, laughter yoga, or art therapy-delivered in a group format over approximately 8 to 10 weeks. The cohort is designed to evaluate changes in quality of life and emotional distress associated with participation in the selected MBT. All participants complete standardized patient-reported outcome measures (EORTC QLQ-C30 and HADS) before and after the therapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life
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.
Measured: From enrollment to the end of treatment at (approximately) 8 weeks
Secondary outcomes (1)
Emotional distress
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.
Measured: From enrollment to the end of treatment at (approximately) 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2025
- Study start1 Dec 2025
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- La Tour Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- OTIUM foundation
- Responsible party
- Principal investigator, Anthony Pernoud, La Tour Hospital
- Investigators
- Anthony Pernoud, MSc, Study chair, La Tour Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07283627
- Sponsor's protocol ID
- 2025-00543
- Other IDs
- 2025
- Acronym
- MBT & cancer
- Status last verified
- Dec 2025
- First submitted
- 4 Dec 2025
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Evolution of Quality of Life and Emotional Distress Among Cancer Patients Participating in Mind-body Therapies
- ClinicalTrials.gov ID
- NCT07283627
- Acronym / sponsor ID
- MBT & cancer / 2025-00543
- Conditions
- Cancer, Mind-Body Therapies
- Keywords
- Cancer, Supportive care, Patient-reported outcomes, Emotional distress, Mind-body therapies, Quality of life, Mindfulness, Laughter yoga
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- La Tour HospitalUniversity, hospital or other
- Collaborators
- OTIUM foundation
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 16 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OTIUM Minb-body therapy cohort | – | –This cohort includes adult cancer patients participating in one specific mind-body therapy (MBT) offered at the OTIUM Centers in Geneva and Meyrin. Eligible participants take part in a structured program-mindfulness, laughter yoga, or art therapy-delivered in a group format over approximately 8 to 10 weeks. The cohort is designed to evaluate changes in quality of life and emotional distress associated with participation in the selected MBT. All participants complete standardized patient-reported outcome measures (EORTC QLQ-C30 and HADS) before and after the therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study participants will be selected from individuals receiving supportive oncology services at the OTIUM Centers located in Geneva and Meyrin, Switzerland. These centers provide mind-body therapies as part of routine integrative care for adults living with or recovering from cancer. Patients typically come from the greater Geneva region and may be referred by oncologists at Hôpital de La Tour or may self-present to the centers to participate in non-pharmacological supportive programs. The study population therefore reflects a real-world clinical population engaged in mind-body therapies within an outpatient supportive care setting.
Key inclusion criteria (4 listed)
- Patient diagnosed with cancer
- Acceptance and signature of an informed consent form
- Age of majority
- Completion of one of the therapies concerned.
Key exclusion criteria (6 listed)
- Withdrawal of the signed informed consent form
- Metastatic cancer
- Cancer recurrence
- Drugs use against stress
- Memory disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Quality of life
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.
1 secondary outcome
Emotional distress
Time frame: From enrollment to the end of treatment at (approximately) 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anthony Pernoud, MSc study chair
La Tour Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Mind-Body Therapies, run by La Tour Hospital at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life (time frame: From enrollment to the end of treatment at (approximately) 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2025.