EVALUATION OF THE BENEFITS OF SOPHROLOGY FOR PATIENTS UNDERGOING RADIOTHERAPY
ConditionRadiation Therapy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorClinique Pasteur Lanroze
About this trial
Anxiety is a common symptom among patients undergoing radiation therapy, stemming from their cancer diagnosis, anticipation of side effects, and the specific challenges associated with the treatment sessions. The technical nature of the treatment, the medical setting, and the daily repetition of sessions can exacerbate this anxiety. This anxiety is likely to impair quality of life, treatment tolerance, and patient adherence to the care pathway. In this context, managing anxiety during radiation therapy is a major challenge in supportive care. Since 2021, the Finistère Center for Radiation Therapy and Oncology has been offering sophrology sessions to its cancer patients as part of a comprehensive support program aimed at improving their quality of life. The aim of the study is to assess the potential benefits of this approach and better understand its impact on patients' experiences during treatment.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults with cancer requiring radiation therapy lasting at least 3 weeks,
Primary sites: ENT cancers, Thoracic cancers, Breast cancers, Pelvic cancers, Gastrointestinal cancers
WHO performance status 0 or 1
Disqualifiers
Patients undergoing treatment other than radiation therapy alone
Patients already attending sophrology sessions elsewhere
Patients under protective measures
Patients receiving psychiatric care
Trial design
Design model
Single group
Treatments tested in this trial
Sophrology
BehavioralHere is the standard sequence of a sophrology session * Welcome, discussion of the patient's physical and mental state. Presentation of the session's objective * Practice of dynamic relaxation exercises while standing or sitting: gentle body movements combined with breathing to release muscle tension * Practice in a semi-reclined position on a chair: controlled breathing exercises, physical and mental relaxation, and positive visualization during which the patient is guided to imagine soothing images or situations to promote overall relaxation * Winding down and discussion: the patient is invited to express their feelings, without interpretation or analysis
Treatment groups
54 Participants
are divided into 1 treatment groupGroup A: SophrologyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Anxiety measurement
Anxiety level is assessed with STAI questionnaire. The STAI questionnaire is a self-report anxiety questionnaire. It consists of 40 items divided (20-20) into two subscales: "trait" anxiety (which represents the patient's baseline anxiety outside of any specific situation) and "state" anxiety, which corresponds to a given situation. Each subscale ranges from 20 to 80. The trait anxiety scale asks the respondent to assess their level of anxiety in life in general. The respondent indicates their answer using a 1-to-4 Likert scale. The state anxiety scale asks the respondent to assess their level of anxiety at the present moment. The respondent indicates their answer using a 1-to-4 Likert scale.
Time frame
7 days before initiation of radiation therapy - 2 weeks after initiation of radiation therapy - 4 weeks after initiation of radiation therapy - 2 weeks after end of radiotherapySponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: