Status:
RECRUITING
Interest of Medical Hypnosis in Anxious Patients Treated by Radiotherapy
Lead Sponsor:
Institut Claudius Regaud
Conditions:
Solid Tumor
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This phase II, randomized, non-comparative and monocentric study aims to evaluate the interest of medical hypnosis in the management of anxiety in patients who are moderately anxious, anxious or very ...
Eligibility Criteria
Inclusion
- Age ≥ 18 years at the time of enrollment into the study.
- Patient with localized or metastatic solid malignant tumor.
- Patient being followed for the cancer pathology at IUCT-O and to receive, for the first time in the follow-up, treatment by radiotherapy (radiotherapy treatment should not have been initiated prior to inclusion in the study).
- Patient for whom radiotherapy treatment includes at least 15 sessions of radiation therapy.
- Patient defined as moderately anxious, anxious or very anxious after completing the STAI-Y self-assessment questionnaire (i.e. ≥ 46 score at inclusion).
- ECOG patient ≤ 2.
- Patient who signed informed consent prior to inclusion in the study and prior to any specific study procedures.
- Patient affiliated to a Social Health Insurance in France.
Exclusion
- Patient doesn't understand the French language.
- Patient with psychiatric disorders requiring antidepressant or antipsychotic treatment.
- Patient with hearing problems.
- Pregnant or breastfeeding women.
- Any psychological, family, geographical or sociological condition that prevents compliance with the medical follow-up and/or procedures of the study protocol.
- Patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice).
Key Trial Info
Start Date :
December 7 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2026
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT04513444
Start Date
December 7 2020
End Date
February 1 2026
Last Update
April 4 2025
Active Locations (1)
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1
Institut Universitaire du Cancer de Toulouse - Oncopole
Toulouse, France, 31059