Interest of Medical Hypnosis in Anxious Patients Treated by Radiotherapy (NCT04513444) | Clinical Trial Compass
RecruitingPhase 2
Interest of Medical Hypnosis in Anxious Patients Treated by Radiotherapy
France45 participantsStarted 2020-12-07
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Rate of patients with at least a 10-point decrease in anxiety score (evolution between the baseline and the 6th and last radiotherapy session)
. 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 criteria
. 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).