Impact of an Educational Physiotherapy-Yoga Intervention on Perceived Stress in Women Treated With Brachytherapy for Cervical Cancer
- Conditions
- Cervical CancerBrachytherapy
- Interventions
- Other: session of Kine-Yoga
- Registration Number
- NCT06263283
- Lead Sponsor
- Institut du Cancer de Montpellier - Val d'Aurelle
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 80
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental Group session of Kine-Yoga 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.
- Primary Outcome Measures
Name Time Method 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 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.
- Secondary Outcome Measures
Name Time Method 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 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
assessment in the experimental group: safety and patient compliance at the Kine-Yoga-PEP intervention 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
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. 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.
Evaluation of the evolution of fatigue during uterovaginal brachytherapy During the uterovaginal brachytherapy. Fatigue score obtained on Visual Analogue Scale (VAS) during uterovaginal brachytherapy
assessment of the psychological distress at inclusion and 15 days after the uterovaginal brachytherapy 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
Description of the use of anxiolytics by group (experimental vs control) 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
Trial Locations
- Locations (3)
ICM
🇫🇷Montpellier, France
Centre Eugène Marquis
🇫🇷Rennes, France
Oncopole Claudius Regaud
🇫🇷Toulouse, France