CClinicalTrials.gg
Not yet recruitingNCT07652060SORA-RTUpdated Jun 16, 2026

EVALUATION OF THE BENEFITS OF SOPHROLOGY FOR PATIENTS UNDERGOING RADIOTHERAPY

An interventional study of Sophrology in Radiation Therapy, sponsored by Clinique Pasteur Lanroze. Not yet recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-16.

Sponsored by Clinique Pasteur Lanroze · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
54
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Radiation Therapy

Browse trials for

Keywords

  • radiation therapy
  • anxiety
  • sophrology
03

In context

Anxiety Disorders

4,864 studies on the registry are indexed under Anxiety Disorders; 1,388 are open to participants now.

This study's planned enrollment of 54 is below the median of 80 across 4,170 interventional studies indexed under Anxiety Disorders.

Browse Anxiety Disorders studies →

Lead sponsor

Clinique Pasteur Lanroze is the lead sponsor of 3 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
54 participants (estimated)

Study arms

  • Experimental
    Sophrology

    Behavioral: Sophrology

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

06

What researchers measure

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 radiotherapy

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07652060
Lead sponsor
Clinique Pasteur Lanroze
Responsible party
Sponsor
First posted
Jun 16, 2026
Start date
Jul 1, 2026 (estimated)
Primary completion
Jul 31, 2028 (estimated)
Completion
Aug 31, 2028 (estimated)
Last update
Jun 16, 2026

Study contacts

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

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion