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

Institut du Cancer de Montpellier - Val d'Aurelle

Status: Active, not recruiting

Conditions: Brachytherapy; Cervical Cancer

Treatments: Other: session of Kine-Yoga

Study type: Interventional

Funder types: Other

Identifiers

NCT06263283

PROICM 2023-04 KYO

Details and patient eligibility

About

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.

Enrollment: 98 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

98 participants in 2 patient groups

Control Group

No Intervention group

Description:

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

Experimental group

Description:

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.

Treatment:

Other: session of Kine-Yoga