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EVALUATION OF THE BENEFITS OF SOPHROLOGY FOR PATIENTS UNDERGOING RADIOTHERAPY

EVALUATION OF THE BENEFITS OF SOPHROLOGY FOR PATIENTS UNDERGOING RADIOTHERAPY

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07652060
Acronym
SORA-RT
Enrollment
54
Registered
2026-06-16
Start date
2026-07-01
Completion date
2028-08-31
Last updated
2026-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Radiation Therapy

Keywords

radiation therapy, anxiety, sophrology

Brief summary

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

BEHAVIORALSophrology

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 images or situations to promote overall relaxation * Winding down and discussion: the patient is invited to express their feelings, without interpretation or analysis

Sponsors

Clinique Pasteur Lanroze
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Anxiety measurement7 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 radiotherapyAnxiety 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.

Countries

France

Contacts

CONTACTMarion Mandon, PhD
mmandon@vivalto-sante.com+33 6 78 27 76 72

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 17, 2026