{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,25]],"date-time":"2026-06-25T23:58:37Z","timestamp":1782431917103,"version":"3.54.5"},"reference-count":36,"publisher":"BMJ","issue":"6","license":[{"start":{"date-parts":[[2025,6,4]],"date-time":"2025-06-04T00:00:00Z","timestamp":1748995200000},"content-version":"unspecified","delay-in-days":3,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"French Health Ministry","award":["Grant number PHRIP 22-0086"],"award-info":[{"award-number":["Grant number PHRIP 22-0086"]}]},{"name":"SIRIC Montpellier Cancer","award":["Grant INCa-DGOS-INSERM-ITMO Cancer_18004"],"award-info":[{"award-number":["Grant INCa-DGOS-INSERM-ITMO Cancer_18004"]}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2025,5,23]]},"published-print":{"date-parts":[[2025,6]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>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\u2019 experiences with the intervention and UBT.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>This study was approved by the French ethics committee (Comit\u00e9 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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT06263283\">NCT06263283<\/jats:ext-link>\n                      .\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2024-098570","type":"journal-article","created":{"date-parts":[[2025,6,4]],"date-time":"2025-06-04T15:25:45Z","timestamp":1749050745000},"page":"e098570","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":2,"title":["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)"],"prefix":"10.1136","volume":"15","clinical-trial-number":[{"clinical-trial-number":"nct06263283","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct06263283","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-1231-1108","authenticated-orcid":false,"given":"Kerstin","family":"Faravel","sequence":"first","affiliation":[{"name":"Department of Supportive and Palliative Care, Montpellier Cancer Institute, Montpellier, France"},{"name":"University of Montpellier, Montpellier, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sylvain","family":"Demontoy","sequence":"additional","affiliation":[{"name":"University of Montpellier, Montpellier, France"},{"name":"Department of Radiotherapy, Montpellier Cancer Institute, Montpellier, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marta","family":"Jarlier","sequence":"additional","affiliation":[{"name":"University of Montpellier, Montpellier, France"},{"name":"Biometrics Unit, Montpellier Cancer Institute, Montpellier, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mailys","family":"De-Meric-de-Bellefon","sequence":"additional","affiliation":[{"name":"University of Montpellier, Montpellier, France"},{"name":"Department of Radiotherapy, Montpellier Cancer Institute, Montpellier, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marie","family":"Cantaloube","sequence":"additional","affiliation":[{"name":"Department of Radiotherapy, Montpellier Cancer Institute, Montpellier, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Estelle","family":"Laboureur","sequence":"additional","affiliation":[{"name":"Cabinet FAHAM, Saint-Paul, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Laetitia","family":"Meignant","sequence":"additional","affiliation":[{"name":"University of Montpellier, Montpellier, France"},{"name":"Clinical Research and Innovation Department, Montpellier Cancer Institute, Montpellier, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maguy","family":"Del Rio","sequence":"additional","affiliation":[{"name":"University of Montpellier, Montpellier, France"},{"name":"Department of Care Management and Biomedical Services, Montpellier Cancer Institute, Montpellier, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Estelle","family":"Guerdoux","sequence":"additional","affiliation":[{"name":"Department of Supportive and Palliative Care, Montpellier Cancer Institute, Montpellier, France"},{"name":"Desbrest Institute of Epidemiology and Public Health, Montpellier, France"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2025,6,4]]},"reference":[{"key":"2025121221265828000_15.6.e098570.1","unstructured":"Lap\u00f4tre-Ledoux B . Main cancer incidence in metropolitan France in 2023 and trend since 1990. Bulletin \u00c9pid\u00e9miologique Hebdomadaire 2023;188\u2013204."},{"key":"2025121221265828000_15.6.e098570.2","doi-asserted-by":"publisher","DOI":"10.3322\/CAAC.21834"},{"key":"2025121221265828000_15.6.e098570.3","unstructured":"Institut National du Cancer . 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