NCT04513444 Interest of Medical Hypnosis in Anxious Patients Treated by Radiotherapy
| NCT ID | NCT04513444 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Institut Claudius Regaud |
| Condition | Solid Tumor |
| Study Type | INTERVENTIONAL |
| Enrollment | 45 participants |
| Start Date | 2020-12-07 |
| Primary Completion | 2027-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 45 participants in total. It began in 2020-12-07 with a primary completion date of 2027-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 anxious during their radiotherapy treatment. 45 patients will be randomized into the following arms: * Arm A (standard): relaxation with music listening during radiotherapy treatment * Arm B (experimental): relaxation with music listening and hypnosis during radiotherapy treatment For the study each patient will be followed during 2 months.
Eligibility Criteria
Inclusion Criteria: 1. Age ≥ 18 years at the time of enrollment into the study. 2. Patient with localized or metastatic solid malignant tumor. 3. 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). 4. Patient for whom radiotherapy treatment includes at least 15 sessions of radiation therapy. 5. Patient defined as moderately anxious, anxious or very anxious after completing the STAI-Y self-assessment questionnaire (i.e. ≥ 46 score at inclusion). 6. ECOG patient ≤ 2. 7. Patient who signed informed consent prior to inclusion in the study and prior to any specific study procedures. 8. Patient affiliated to a Social Health Insurance in France. Exclusion Criteria: 1. Patient doesn't understand the French language. 2. Patient with psychiatric disorders requiring antidepressant or antipsychotic treatment. 3. Patient with hearing problems. 4. Pregnant or breastfeeding women. 5. Any psychological, family, geographical or sociological condition that prevents compliance with the medical follow-up and/or procedures of the study protocol. 6. Patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice).
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04513444 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Solid Tumor. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04513444 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT04513444 currently recruiting?
Yes, NCT04513444 is actively recruiting participants. Contact the research team at ducassou.anne@iuct-oncopole.fr for enrollment information.
Where is the NCT04513444 trial being conducted?
This trial is being conducted at Toulouse, France.
Who is sponsoring the NCT04513444 clinical trial?
NCT04513444 is sponsored by Institut Claudius Regaud. The trial plans to enroll 45 participants.