EVALUATION OF THE BENEFITS OF SOPHROLOGY FOR PATIENTS UNDERGOING RADIOTHERAPY

NCT07652060 | Not Yet Recruiting

• 1 other identifier: 2025-45-CPL
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Radiation Therapy

Keywords

radiation therapy; anxiety; sophrology

Outcome Measures

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.

  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

Study Arms (1)

Sophrology

EXPERIMENTAL

Behavioral: Sophrology

Interventions

Sophrology BEHAVIORAL

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

Sophrology

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Clinique Pasteur Lanroze: lead

Study Sites (1)

Clinique Pasteur Lanroze

Brest, 29000, France

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Central Study Contacts

Marion Mandon, PhD

CONTACT

+33 6 78 27 76 72; mmandon@vivalto-sante.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2026
• First Posted: June 16, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): August 31, 2028
• Last Updated: June 16, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)