Kerstin Faravel

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 .

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

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.