Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 4:02 PM
Ignite Modification Date:
2025-12-26 @ 4:02 PM
NCT ID:
NCT04999306
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18 years
* World Health Organization (WHO) status ≤ 2
* Colorectal adenocarcinoma in progression after first line metastatic chemotherapy
* Able to understand and read French
* Visual Analog Scale (VAS) fatigue ≥ 4
* Patient starting a second or third line of metastatic chemotherapy
* Patient having signed the informed consent
* Patient subscribing to a French Social Security system
Exclusion Criteria:
* Patients without phones or devices for sessions at home
* Bradycardia (\< 50 beats/minute) with β-blockers
* Known severe heart failure with ventricular ejection fraction \< 40%.
* Presence of known or symptomatic brain metastases
* Chronic pain evolving for more than three months and using morphine
* Patient used to and having a regular and habitual practice of relaxation techniques such as yoga, hypnosis, sophrology, meditation.
* Medical (neurological, psychiatric, etc.) or psychological conditions that do not allow participation in the protocol (filling out the questionnaires, the booklet, as well as following the sessions)
* Hearing-impaired patient without hearing aids
* Patient under guardianship or legal protection
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04999306
Study Brief:
Protocol Section:
NCT04999306