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

NCT06263283Active, Not RecruitingNAINTERVENTIONAL

Summary

Key Facts

Lead Sponsor

Institut du Cancer de Montpellier - Val d'Aurelle

Enrollment

98

Start Date

2024-06-03

Completion Date

2026-08-01

Study Type

INTERVENTIONAL

Official Title

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

Interventions

session of Kine-Yoga

Conditions

Cervical CancerBrachytherapy

Eligibility

Age Range

18 Years+

Sex

FEMALE

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

Outcome Measures

Primary Outcomes

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.

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 frame: Time from the randomization to 15 days after uterovaginal brachytherapy

Secondary Outcomes

assessment in the experimental group: safety and patient compliance at the Kine-Yoga-PEP intervention

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 frame: 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.

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.

Time frame: During the uterovaginal brachytherapy.

Evaluation of the evolution of fatigue during uterovaginal brachytherapy

Fatigue score obtained on Visual Analogue Scale (VAS) during uterovaginal brachytherapy

Time frame: During the uterovaginal brachytherapy.

assessment of the psychological distress at inclusion and 15 days after the 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 frame: Time from the baseline to 15 days after uterovaginal brachytherapy

Description of the use of anxiolytics by group (experimental vs control)

The use of anxiolytic treatments will be described in the logbooks filled out by the patients

Time frame: 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

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

Time frame: Between 7 or 12 days after the uterovaginal brachytherapy

Locations

ICM, Montpellier, France

Centre Eugène Marquis, Rennes, France

Oncopole Claudius Regaud, Toulouse, France

Linked Papers

2025-06-04

Impact of an educational physiotherapy-yoga intervention on perceived stress in women treated with brachytherapy for cervical cancer: a randomised controlled mixed study protocol (KYOCOL)

Introduction Cervical cancer is a major global health issue. The standard treatment for locally advanced disease involves radiochemotherapy followed by uterovaginal brachytherapy (UBT). UBT requires several days of hospitalisation and strict bed rest. UBT often induces pain, anxiety, stress, distress and a decline in physical capacity during and after treatment. Previous research suggests that non-pharmacological interventions, such as yoga, may help alleviate these issues. However, few studies have specifically evaluated their effectiveness in reducing stress during UBT. Furthermore, patient education has been shown to facilitate autonomous practice and to improve patient empowerment. This study aims to evaluate the impact of the KYOCOL protocol, which integrates both a physiotherapy-yoga intervention and an educational programme, on perceived stress and its correlates in patients undergoing UBT. Methods and analysis KYOCOL is an ongoing randomised, prospective trial carried out in three French comprehensive cancer centres, using a quantitative approach complemented by a qualitative component. Eighty patients are planned to be randomised (1:1) into a control arm (standard care) or an intervention arm. In the intervention arm, patients will be educated and supervised by a trained physiotherapist in a physiotherapy-yoga programme and will then perform daily autonomous sessions during UBT and for up to 15 days post-treatment. The primary objective is to assess the impact of the KYOCOL intervention compared with standard care during UBT, on perceived stress 15 days post-UBT, using the 10-item Perceived Stress Scale. Secondary objectives include evaluating the safety of the intervention, its effects on stress, pain and fatigue during UBT, and patient adherence to the programme. Qualitative analyses based on semistructured interview surveys will be conducted to gather valuable information and analyse in depth patients’ experiences with the intervention and UBT. Ethics and dissemination This study was approved by the French ethics committee (Comité de Protection des Personnes Ouest V, reference number 2023-A01491-44) on 22 February 2024 and will be carried out in accordance with the good clinical practice guidelines and the Declaration of Helsinki. The results will be shared with patients and healthcare professionals and published in a peer-reviewed journal. Trial registration number NCT06263283 .

The Symptom Experience and Self-management Strategies of Women Undergoing Cervical Cancer Treatment

Background Cervical cancer treatment modalities, such as surgery, chemotherapy, radiation, and brachytherapy, often result in short- and long-term adverse effects such as nausea, fatigue, and sexual dysfunction. Chemotherapy and radiation are typically provided on an outpatient basis, requiring women to be more active in self-managing their symptoms at home. Objective The aim of this study was to explore how women with cervical cancer experience symptoms and manage daily life during treatment. Methods Individual interviews with 10 women diagnosed with cervical cancer and undergoing curative concurrent chemotherapy and radiation were carried out. Data analysis was conducted using a phenomenological-hermeneutic perspective, inspired by Ricoeur. Results Three themes were identified based on the interviews: (1) new life perspectives, (2) suffering in silence, and (3) enhanced symptom self-management strategies. Conclusion Diagnosis and treatment create an opportunity for the women to critically reflect on their lives and to develop new life perspectives. During treatment, a mental transformation involving the use of various individual social, mental, and physical coping strategies allowed the women to manage their daily lives. This enabled self-management strategies, resulting in maintaining a sense of normalcy, trying to defy the adverse effects, and prioritizing themselves, their families, and the treatment. Implications for Practice Women with cervical cancer undergoing oncological treatment need more specific and detailed information about the course of treatment, symptom management, adverse effects, and psychological reactions to better manage their daily lives. Healthcare professionals play a crucial role in supporting and guiding the women and in ensuring optimal symptom management.

Linked Investigators