Impact of an Educational Physiotherapy-Yoga Intervention on Perceived Stress in Women Treated With Brachytherapy for Cervical Cancer (KYOCOL)

February 23, 2026 updated by: Institut du Cancer de Montpellier - Val d'Aurelle

Impact of an Educational Physiotherapy-Yoga Intervention on Perceived Stress in Women Treated With Brachytherapy for Cervical Cancer: a Randomized Controlled Trial

Every year in France, nearly 3,000 women develop a cervical cancer. The average age of women diagnosed is 51. Uterovaginal brachytherapy is one of the reference treatments.

To allow this treatment, an applicator is first placed under general anaesthesia in the vaginal zone. Then, the pulsed Dose Rate (PDR) or high dose rate (HDR) uterovaginal brachytherapy requires 2-5 days hospitalization in an isolated room. Uterovaginal brachytherapy requires strict bed rest without movements allowed for the pelvic area until the applicator is removed.

Prolonged immobilization, the context of the illness and the intimacy of the area to be treated are all recognized sources of anxiety. According to a study, 40% of patients have post-traumatic stress at 3 months of treatment. A Danish team highlights the significant decrease in physical capacity during and after treatment.

Thus, as a recent literature review concludes, there is a real need to develop Non-Pharmacological-Interventions (NPI) to limit the aftereffects. It also seems important to provide support for self-management of symptoms.

Among NPI of interest, Yoga is a mind-body practice that can decrease perceived stress. A systematic review confirms that yoga can reduce stress during cancer treatment. This underlines the importance of proposing this practice for patients treated for all types of cancers and further evaluations on the effects of respiratory and meditation exercises. Another team showed the feasibility of respiratory exercise intervention in patients undergoing chemotherapy while also talking about mental health benefits. Finally, a reduction in perceived stress was achieved in women treated with radiotherapy for breast cancer through yoga intervention. A lot of work has been done with promising results without the result of a consensus applicable to all care situations.

Moreover, educational requirements are high in women treated to gynecological cancer.

Meeting these needs helps to improve quality of life, pain management and drug use.

Integrating Patient Educational Project (PEP) therefore seems relevant as an additional tool in patient empowerment. In addition, the fact that a combined Physiotherapy-Yoga-PEP intervention is feasible in women treated for breast cancer allows us to offer adjusted version in patients with brachytherapy.

The literature review thus invites us to propose the educational intervention Kine-Yoga-PEP in the very particular context of brachytherapy.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

98

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Montpellier, France, 34298
        • ICM
      • Rennes, France, 35000
        • Centre Eugene Marquis
      • Toulouse, France, 21059
        • Oncopole Claudius Regaud

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Woman 18 ≥ years old, no age limit
  • Patient treated for cervical cancer (histologically proven) by uterovaginal brachytherapy
  • Patient with stress level ≥ 3 on VAS from 0 to 10
  • Patient´s signed written informed consent
  • Affiliation to a French Social Security System

Exclusion Criteria:

  • Physical alteration not allowing the practice of Yoga,
  • Patient does not understand and does not speak French
  • Patient whose regular follow-up is initially impossible for psychological, family, social or geographical reasons,
  • Patient under guardianship or safeguard of justice

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Group
Standard care according to the modalities of each center (concomitant treatment prescription, psychological support, physiotherapy or dietetic are supports that can be proposed if needed)
Experimental: Experimental Group

Standard support with Daily realization of a session of Kine-Yoga supervised by a physiotherapist at J2, J3 and J4 of uterovaginal brachytherapy.

Possibility for the patient to practice this session in autonomy (using PEP tools given to the Shared Educational Check-up) according to her wish during the duration of the treatment and up to 15 days post treatment.
Other: session of Kine-Yoga

Daily performance of a Kine-Yoga-PEP intervention supervised by a physiotherapist of the department trained in the Kine-Yoga-PEP intervention at J2, J3 and J4 of uterovaginal brachytherapy.

Possibility for the patient to practice this session in autonomy (using PEP tools given to the Shared Educational Check-up) according to her wish during the duration of the treatment and up to 15 days post treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of the Kine-Yoga-PEP intervention to standard care during the uterovaginal brachytherapy on perceived stress at 15 days of treatment initiation in patients treated for cervical cancer.
Time Frame: Time from the randomization to 15 days after uterovaginal brachytherapy
The Perceived Stress Score will be assessed by the 10-item Perceived Stress Scale (PSS) self-assessment 15 days after the start of the uterovaginal brachytherapy.
Time from the randomization to 15 days after uterovaginal brachytherapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
assessment in the experimental group: safety and patient compliance at the Kine-Yoga-PEP intervention
Time Frame: Time from the randomization to 15 days after uterovaginal brachytherapy
The safety will be evaluated by Number of treatment interruptions due to applicator displacement and/or source friction following Kine-Yoga-PEP intervention. Patient compliance will be evaluated by the number of sessions performed (supervised and independent) collected on the logbooks filled out by the patients
Time from the randomization to 15 days after uterovaginal brachytherapy
Evaluation of the immediate effect of the Kine-Yoga-PEP intervention in the experimental group on perceived stress, pain (overall and due to immobility) and the evolution of these parameters during brachytherapy.
Time Frame: During the uterovaginal brachytherapy.
Scores obtained at the Visual Analog Scales (VAS) of stress and EVA of pain (global and immobility-related), before and after Kine-Yoga-PEP intervention and during uterovaginal brachytherapy.
During the uterovaginal brachytherapy.
Evaluation of the evolution of fatigue during uterovaginal brachytherapy
Time Frame: During the uterovaginal brachytherapy.
Fatigue score obtained on Visual Analogue Scale (VAS) during uterovaginal brachytherapy
During the uterovaginal brachytherapy.
assessment of the psychological distress at inclusion and 15 days after the uterovaginal brachytherapy
Time Frame: Time from the baseline to 15 days after uterovaginal brachytherapy
Anxiety-Depressive Distress Score measured by the Hospital Anxiety and Depression Scale (HADS) Questionnaire for uterovaginal Brachytherapy at inclusion and 15 days after the uterovaginal brachytherapy
Time from the baseline to 15 days after uterovaginal brachytherapy
Description of the use of anxiolytics by group (experimental vs control)
Time Frame: Time from the baseline to 15 days after uterovaginal brachytherapy
The use of anxiolytic treatments will be described in the logbooks filled out by the patients
Time from the baseline to 15 days after uterovaginal brachytherapy
Description of the experiences of patients treated for cervical cancer during uterovaginal brachytherapy receiving a Kine-Yoga-PEP intervention (approximately 20 patients in the experimental group
Time Frame: Between 7 or 12 days after the uterovaginal brachytherapy
The diversity of verbatim and semantic themes collected by a 40 - 60 minute semi-directional interview (qualitative analysis) in the week following the removal of the applicator from patients until data saturation (approximately 20 patients in the experimental group
Between 7 or 12 days after the uterovaginal brachytherapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut du Cancer de Montpellier - Val d'Aurelle

Investigators

  • Study Director: Aurore MOUSSION, INSTITUT REGIONAL DU CANCER DE MONTPELLIER Cancer de Montpellier
  • Principal Investigator: Kerstin FARAVEL, INSTITUT REGIONAL DU CANCER DE MONTPELLIER Cancer de Montpellier

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 3, 2024

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2026

Study Registration Dates

First Submitted

February 9, 2024

First Submitted That Met QC Criteria

February 9, 2024

First Posted (Actual)

February 16, 2024

Study Record Updates

Last Update Posted (Actual)

February 24, 2026

Last Update Submitted That Met QC Criteria

February 23, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PROICM 2023-04 KYO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual Participant Data will not be shared at an individual level. Those data will be part of the study database including all enrolled patients All participant data collected during the trial, after encoding with an inclusion number, 1st letter of the name and surname may be shared.

The data of the participants will be available upon request and with the completion of a contract between the promoter and the applicant.

The study protocol, the statistical analysis plan (PAS) and the analytical code may also be subject to data sharing as part of a transfer contract (RGPD)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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