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Not yet recruiting NCT07652060

EVALUATION OF THE BENEFITS OF SOPHROLOGY FOR PATIENTS UNDERGOING RADIOTHERAPY

No phase Interventional Radiation Therapy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Sophrology.
Who it may be relevant to
Registry conditions: Radiation Therapy. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Behavioral Sophrology
    Here 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

Primary outcome measures

  • Anxiety measurement [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 radiotherapy]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • Patients undergoing treatment other than radiation therapy alone
  • Patients already attending sophrology sessions elsewhere
  • Patients under protective measures
  • Patients receiving psychiatric care
  • Pregnant or breastfeeding patients
  • Patients not covered by social security

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Supportive care

Study locations

France · 1 center
  • Clinique Pasteur Lanroze — Brest

Identifiers

NCT: NCT07652060 · 2025-45-CPL

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗