NCT07283627

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).

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
8mo left

Started Dec 2025

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress40%
Dec 2025Jan 2027

Study Start

First participant enrolled

December 1, 2025

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

December 4, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 16, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

December 24, 2025

Status Verified

December 1, 2025

Enrollment Period

1.1 years

First QC Date

December 4, 2025

Last Update Submit

December 17, 2025

Conditions

Keywords

CancerSupportive carePatient-reported outcomesEmotional distressMind-body therapiesQuality of lifeMindfulnessLaughter yogaArt therapyIntegrative oncology

Outcome Measures

Primary Outcomes (1)

  • 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.

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

Secondary Outcomes (1)

  • Emotional distress

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

Study Arms (1)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

La Tour Hospital

Meyrin, Canton of Geneva, 1217, Switzerland

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Anthony Pernoud, MSc

    La Tour Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Project Manager

Study Record Dates

First Submitted

December 4, 2025

First Posted

December 16, 2025

Study Start

December 1, 2025

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Last Updated

December 24, 2025

Record last verified: 2025-12

Locations