Clinical trial NCT06263283: Impact of an Educational Physiotherapy-Yoga Intervention on Perceived Stress in Women Treated With Brachytherapy for Cervical Cancer
Official title: Impact of an Educational Physiotherapy-Yoga Intervention on Perceived Stress in Women Treated With Brachytherapy for Cervical Cancer: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cervical Cancer
Brachytherapy
Keywords: cervical cancer
uterovaginal brachytherapy
stress
Prolonged immobilization
yoga
Lead sponsor: Institut du Cancer de Montpellier - Val d'Aurelle
Sponsor class: OTHER
First posted: 2024-02-16
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 Group: Standard support with Daily realization of a session of Kine-Yoga supervised by a physiotherapist at J2, J3 and J4 of uterovaginal brachytherapy.
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: Time from the randomization to 15 days after uterovaginal brachytherapy
Secondary outcomes:
measure: assessment in the experimental group: safety and patient compliance at the Kine-Yoga-PEP intervention
timeFrame: Time from the randomization to 15 days after uterovaginal brachytherapy
measure: 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.
timeFrame: During the uterovaginal brachytherapy.
measure: Evaluation of the evolution of fatigue during uterovaginal brachytherapy
timeFrame: During the uterovaginal brachytherapy.
measure: assessment of the psychological distress at inclusion and 15 days after the uterovaginal brachytherapy
timeFrame: Time from the baseline to 15 days after uterovaginal brachytherapy
measure: Description of the use of anxiolytics by group (experimental vs control)
timeFrame: Time from the baseline to 15 days after uterovaginal brachytherapy
measure: 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
timeFrame: Between 7 or 12 days after the uterovaginal brachytherapy
Other outcomes:
Locations:
city: Montpellier
country: France
facility: ICM
city: Rennes
country: France
facility: Centre Eugène Marquis
city: Toulouse
country: France
facility: Oncopole Claudius Regaud
Study officials:
affiliation: INSTITUT REGIONAL DU CANCER DE MONTPELLIER Cancer de Montpellier
name: Aurore MOUSSION
role: STUDY_DIRECTOR
affiliation: INSTITUT REGIONAL DU CANCER DE MONTPELLIER Cancer de Montpellier
name: Kerstin FARAVEL
role: PRINCIPAL_INVESTIGATOR
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