Search

Background: 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., Methods: 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., Discussion: 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., Trial Registration: 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., Protocol: version 4, 22 December 2022., Competing Interests: Declarations. Ethics approval and consent to participate: The study protocol and its amendments obtained approval from the French Ethics Committee (Comité de protection des personnes Ile de France VII) (ref 22.00242.000081) in March 2022. The study is conducted in accordance with the Declaration of Helsinki and General Data Protection Regulation (GDPR). Written non-opposition will be obtained from each patient by the investigator before any study-related assessment starts. Competing interests: The authors declare no competing interests., (© 2025. The Author(s).)

Background: Most breast cancers are detected at an early stage in which case conservative surgery is indicated. An accurate preoperative localization technique is essential for conservative surgery of non-palpable breast lesions. Currently, the gold standard technique is wire localization (WL). However, this technique has well-known drawbacks. Several wire-free techniques have been developed to overcome these drawbacks; one technique is localisation by Radiofrequency Identification (RFID). The purpose of this clinical trial was to assess the superiority of RFID tags (HOLOGIC) in terms of patient satisfaction, over wire localization of non-palpable breast lesions., Methods: This was a single-centre, prospective, controlled and non-interventional trial. Patients were followed from their inclusion at the time of the preoperative consultation to the postoperative consultation, one month after surgery. Data on anxiety and satisfaction was collected from patients and clinicians using questionnaires, and clinical data was collected from the medical files. The primary outcome was the patients' satisfaction scores, assessed using a visual analogue scale., Results: Eighty patients were sequentially enrolled in two groups: the wire group (n = 40) and the RFID group (n = 40). One patient from the RFID group was excluded from the analysis because of a substantial migration during deployment. On a 10-point Visual Analogue Scale, the patients' median satisfaction score was 9.8 (IQR = 1.32) for the wire group and 10 (IQR = 0.07) for the RFID group (p < 0.001). A reduction in pain between device insertion and surgery was observed in the RFID group (p = 0.009). The median placement time was shorter in the RFID group (15 min, IQR = 6) than in the wire group (20 min, IQR = 30) (p = 0.01)., Conclusion: Our results show a statistically significant difference in median patient satisfaction score with the localization of non-palpable breast cancer lesions using RFID tags compared to the use of the WL. Although our results did not show clinically significant outcomes in terms of satisfaction, RFID tags are a reliable alternative to WL and simplify the organization of patients' healthcare trajectories., Trial Registration: ClinicalTrials.gov ID; NCT04750889 registered on February 11, 2021. https://clinicaltrials.gov/ct2/show/NCT04750889?term=rfid&draw=2&rank=1., Competing Interests: Declarations. Ethics approval and consent to participate: The RFID trial was approved by the ethics committee (Ile de France XI) (ID-RCB number: 2021-A00281-40). Patients who agreed to participate in this study provided oral consent for enrolment and the investigator signed a document stating that the patient had been informed and had agreed to participate. Competing interests: The authors declare no competing interests., (© 2025. The Author(s).)

Background: Breast cancer is the most frequently diagnosed cancer and the leading cause of cancer death in women. Approximately 50% of breast cancers are discovered at an early stage in patients for whom conservative surgery is indicated. Intraoperative localization of non-palpable breast lesions is generally accomplished using a hook wire to mark the area of concern under ultrasound or stereotactic localization. But this technique has several drawbacks (painful, stressful…). We propose the use of a wire-free breast lesion system using miniature radiofrequency identification (RFID) tags. This technique could improve patient comfort and surgical comfort for surgeons. We therefore propose a study to assess the interest of introducing the RFID localization technique at the Jean PERRIN comprehensive cancer center., Methods: This is a single-center prospective trial designed to assess the interest in introducing the RFID localization technique at the Jean Perrin center. It aims to show the superiority of the RFID technique in terms of patient tolerance compared to the gold-standard (hook wire). A sequential inclusion in time will be performed: 20 inclusions in the gold-standard group, then 20 patients in the RFID group before repeating the inclusion scheme. Any patient requiring preoperative localization will receive a senology consultation. The RFID tag will be placed during this consultation. The hook wire localization will be done the day before the surgery. Patients will fill out a Hospital Anxiety and Depression scale (HAD) questionnaire at the time of inclusion. They will then fill out a satisfaction questionnaire in 2 steps: during the placement of the device (RFID tag or hook wire) or during the postoperative consultation at 1 month. Radiologists and surgeons will fill out a questionnaire to evaluate the localization technique, respectively after the localization and surgery procedures., Discussion: The RFID study is the first study in France which specifically assesses the interest of the RFID localization in terms of patients comfort. Patient comfort is one of the key elements to take into consideration when managing patients in oncology and new technologies such as RFID tags could improve it., Trial Registration: ClinicalTrials.gov ID; NCT04750889 registered on February 11, 2021., (© 2023. The Author(s).)