Godiveau Mélanie, Passildas Judith, Thivat Emilie, Casile Mélanie, Pinard Céleste, Giro Alexia, Mouret-Reynier Marie-Ange, Molnar Ioana, Abrial Catherine, Bouvier Claude-Eugène, Bignon Yves-Jean, Durando Xavier
Division de la Recherche Clinique, Centre Jean PERRIN, 58 rue Montalembert, Clermont-Ferrand, 63011, France.
Collège des Economistes de la Santé, Villejuif, France.
BMC Cancer. 2025 Jan 29;25(1):174. doi: 10.1186/s12885-025-13524-2.
Over the past twenty years, the post-cancer rehabilitation has been developed, usually in a hospital setting. Although this allows better care organization and improved security, it is perceived as stressful and restrictive by the "cancer survivor". Therefore, the transfer of benefits to everyday life is more difficult, or even uncertain. Staying in a thermal resort seemed to offer a good compromise: the security and structure of centralized reception in a thermal resort for treatment and medical supervision, and accommodation in a hotel with full dietary board. It combines institutional quality and security with the freedom of real life and the dynamics of a group formed under innovative conditions. This rehabilitation procedure was tested with the program PACThe (Program of Accompanying women after breast Cancer treatment completion in Thermal resorts) which was evaluated at one year in a randomized controlled trial involving 251 patients [1] and at five years in another study [2]. The results shown a significative improvement in many areas such as quality of life, functional abilities and sleep. The aim of this study is therefore to confirm the benefits of the PACThe program at six months for breast cancer women in complete remission in real-life conditions.
The project PACThe Real-Life conditions is an observational trial in which 400 breast cancer women in complete remission will be sent to a 3 week thermal "post-cancer rehabilitation" program. Primary objective is to assess the quality of life until 12 months. The outcome will be measured with the self-questionnaire SF-36 [3] at five timepoints (inclusion visit, end of thermal resort, 6 months post-cure, 12 months post-cure and 18 months post-cure). The duration of patient participation in the study will therefore be 18 months. The main analysis will consist of comparing the SF-36 global score at 6 months with the baseline.
This study aims to investigate the improvements in quality of life of 3 weeks stay at thermal resort for breast cancer women in complete remission. The comprehensive overview of the program PACThe will likely contribute to enhancing thermal therapy post-cancer rehabilitation in this population in real life conditions.
The PACThe Real-Life conditions trial is a prospective observational study registered at the ANSM registry (2022-A00171-42) on March 1, 2022. This study has been registered on ClinicalTrials.gov: NCT05433077.
version 4, 22 December 2022.
在过去二十年中，癌症后康复治疗得到了发展，通常是在医院环境中进行。虽然这有助于更好地组织护理并提高安全性，但“癌症幸存者”认为这具有压力且受到限制。因此，将治疗效果转化到日常生活中更加困难，甚至不确定。在温泉度假区进行康复似乎是一个不错的折衷方案：在温泉度假区集中接待进行治疗和医疗监督，同时在提供全食宿的酒店住宿。它将机构的质量和安全性与现实生活的自由以及在创新条件下形成的群体活力结合起来。这种康复程序通过PACThe（乳腺癌治疗完成后在温泉度假区陪伴女性的项目）进行了测试，该项目在一项涉及251名患者的随机对照试验中进行了一年的评估[1]，并在另一项研究中进行了五年的评估[2]。结果显示在许多方面都有显著改善，如生活质量、功能能力和睡眠。因此，本研究的目的是在现实生活条件下，确认PACThe项目对完全缓解的乳腺癌女性在六个月时的益处。
PACThe现实生活条件项目是一项观察性试验，400名完全缓解的乳腺癌女性将被送去参加为期3周的温泉“癌症后康复”项目。主要目标是评估直到12个月时的生活质量。结果将在五个时间点（入组访视、温泉度假区结束时、治愈后6个月、治愈后12个月和治愈后18个月）使用自我问卷SF - 36[3]进行测量。因此，患者参与研究的持续时间将为18个月。主要分析将包括比较6个月时的SF - 36总体得分与基线得分。
本研究旨在调查完全缓解的乳腺癌女性在温泉度假区停留3周后生活质量的改善情况。对PACThe项目的全面概述可能有助于在现实生活条件下增强该人群的温泉疗法癌症后康复效果。
PACThe现实生活条件试验是一项前瞻性观察性研究，于2022年3月1日在法国国家药品安全局（ANSM）注册（2022 - A00171 - 42）。本研究已在ClinicalTrials.gov上注册：NCT05433077。
版本4，2022年12月22日
