PDF(Pubmed)
Abstract：
BACKGROUND: Patients with postmenopausal nonmetastatic estrogen receptor-positive breast cancer often experience a reduced quality of life after primary treatment. The disease and treatment trajectory consists of surgery followed by chemotherapy or radiation therapy. Upon this, maintenance hormone therapy with an aromatase inhibitor can result in several physical and psychosocial symptoms. Optimal symptom control during maintenance therapy is central to maintaining the patient\'s quality of life.
OBJECTIVE: This study aims to (1) develop an electronic symptom management tool for patients with postmenopausal early breast cancer receiving maintenance aromatase inhibitors with an endocrine aspect and (2) assess the feasibility, acceptability, and usability of the pilot version of the Bone@BC app. Furthermore, longitudinally, symptom prevalence and quality of life for patients with postmenopausal nonmetastatic estrogen receptor-positive breast cancer will be explored.
METHODS: This study follows a multistage research plan. In stage 1, a systematic literature review to establish an overview of aromatase inhibitor-related symptoms reported by postmenopausal women with nonmetastatic estrogen receptor-positive breast cancer will be completed. In stage 2, a comprehensive overview of symptoms related to aromatase inhibitors (letrozole, exemestane, and anastrozole) will be performed (eg, by reviewing medical leaflets and guidelines). In stage 3, an electronic app with a user-friendly Patient Concern Inventory list to comprise symptoms and concerns will be developed. Last, in stage 4, a convergent mixed methods feasibility study of the pilot version of the Bone@BC app will be conducted. A total of 45 patients with postmenopausal nonmetastatic estrogen receptor-positive breast cancer will use the app daily for symptom identification and respond to 6 serial patient-reported outcome measurements for 12 weeks. Finally, semistructured interviews will be performed. The primary outcome includes consent rate, attrition rate, retention rates, technical issues, and adherence, assessed using preestablished criteria on feasibility and a mixed methods approach for exploring acceptability. A patient advisory board consisting of 5 women with breast cancer is recruited to include their perspectives and experiences in the planning, organization, implementation, and dissemination of the research throughout the project.
RESULTS: At the time of submitting this paper (January 2024), a total of 23 patients have been included in the stage 2 medical audit over the recruitment period of 3 months (November 2022 to February 2023), and 19 patients have been enrolled in stage 2, the semistructured patient interviews.
CONCLUSIONS: This protocol describes a study investigating the feasibility, acceptability, and usability of the symptom management tool Bone@BC developed for patients with breast cancer with an endocrine aspect.
BACKGROUND: ClinicalTrails.gov NCT05367830; https://clinicaltrials.gov/ct2/show/NCT05367830.
UNASSIGNED: DERR1-10.2196/49549.
OBJECTIVE: This study aims to (1) develop an electronic symptom management tool for patients with postmenopausal early breast cancer receiving maintenance aromatase inhibitors with an endocrine aspect and (2) assess the feasibility, acceptability, and usability of the pilot version of the Bone@BC app. Furthermore, longitudinally, symptom prevalence and quality of life for patients with postmenopausal nonmetastatic estrogen receptor-positive breast cancer will be explored.
METHODS: This study follows a multistage research plan. In stage 1, a systematic literature review to establish an overview of aromatase inhibitor-related symptoms reported by postmenopausal women with nonmetastatic estrogen receptor-positive breast cancer will be completed. In stage 2, a comprehensive overview of symptoms related to aromatase inhibitors (letrozole, exemestane, and anastrozole) will be performed (eg, by reviewing medical leaflets and guidelines). In stage 3, an electronic app with a user-friendly Patient Concern Inventory list to comprise symptoms and concerns will be developed. Last, in stage 4, a convergent mixed methods feasibility study of the pilot version of the Bone@BC app will be conducted. A total of 45 patients with postmenopausal nonmetastatic estrogen receptor-positive breast cancer will use the app daily for symptom identification and respond to 6 serial patient-reported outcome measurements for 12 weeks. Finally, semistructured interviews will be performed. The primary outcome includes consent rate, attrition rate, retention rates, technical issues, and adherence, assessed using preestablished criteria on feasibility and a mixed methods approach for exploring acceptability. A patient advisory board consisting of 5 women with breast cancer is recruited to include their perspectives and experiences in the planning, organization, implementation, and dissemination of the research throughout the project.
RESULTS: At the time of submitting this paper (January 2024), a total of 23 patients have been included in the stage 2 medical audit over the recruitment period of 3 months (November 2022 to February 2023), and 19 patients have been enrolled in stage 2, the semistructured patient interviews.
CONCLUSIONS: This protocol describes a study investigating the feasibility, acceptability, and usability of the symptom management tool Bone@BC developed for patients with breast cancer with an endocrine aspect.
BACKGROUND: ClinicalTrails.gov NCT05367830; https://clinicaltrials.gov/ct2/show/NCT05367830.
UNASSIGNED: DERR1-10.2196/49549.
摘要：
背景：绝经后非转移性雌激素受体阳性乳腺癌患者在初级治疗后往往生活质量下降。疾病和治疗轨迹包括手术，然后进行化学疗法或放射疗法。在这一点上，用芳香化酶抑制剂维持激素治疗可导致多种身体和心理症状。维持治疗期间的最佳症状控制对于维持患者的生活质量至关重要。
目的：本研究旨在（1）为绝经后早期乳腺癌患者开发电子症状管理工具，并接受内分泌方面的芳香化酶抑制剂，（2）评估其可行性，可接受性,和Bone@BC应用程序的试点版本的可用性。此外，纵向,将探讨绝经后非转移性雌激素受体阳性乳腺癌患者的症状发生率和生活质量.
方法：本研究遵循多阶段研究计划。在第1阶段，将完成系统文献综述，以建立绝经后非转移性雌激素受体阳性乳腺癌妇女报告的芳香化酶抑制剂相关症状的概述。在第2阶段，与芳香化酶抑制剂相关的症状的全面概述(来曲唑，依西美坦,和阿那曲唑)将被执行(例如，通过审查医学传单和指南)。在阶段3中，将开发具有用户友好的患者关注清单列表的电子应用程序，以包含症状和关注。最后,在阶段4中，将对Bone@BC应用程序的试点版本进行融合混合方法可行性研究。共有45名绝经后非转移性雌激素受体阳性乳腺癌患者将每天使用该应用程序进行症状识别，并对6个连续患者报告的结果测量结果做出反应，为期12周。最后,将进行半结构化面试。主要结果包括同意率，流失率，保留率，技术问题,和坚持，使用预先建立的可行性标准和探索可接受性的混合方法进行评估。招募了一个由5名乳腺癌女性组成的患者咨询委员会，将她们的观点和经验纳入规划，组织,实施，并在整个项目中传播研究。
结果：在提交本文时（2024年1月），在3个月的招募期内（2022年11月至2023年2月），共有23名患者被纳入第二阶段医疗审核，19名患者已被纳入阶段2，半结构化患者访谈。
结论：本方案描述了一项研究，可接受性,以及为具有内分泌方面的乳腺癌患者开发的症状管理工具Bone@BC的可用性。
背景：ClinicalTrails.govNCT05367830;https://clinicaltrials.gov/ct2/show/NCT05367830。
■DERR1-10.2196/49549。
目的：本研究旨在（1）为绝经后早期乳腺癌患者开发电子症状管理工具，并接受内分泌方面的芳香化酶抑制剂，（2）评估其可行性，可接受性,和Bone@BC应用程序的试点版本的可用性。此外，纵向,将探讨绝经后非转移性雌激素受体阳性乳腺癌患者的症状发生率和生活质量.
方法：本研究遵循多阶段研究计划。在第1阶段，将完成系统文献综述，以建立绝经后非转移性雌激素受体阳性乳腺癌妇女报告的芳香化酶抑制剂相关症状的概述。在第2阶段，与芳香化酶抑制剂相关的症状的全面概述(来曲唑，依西美坦,和阿那曲唑)将被执行(例如，通过审查医学传单和指南)。在阶段3中，将开发具有用户友好的患者关注清单列表的电子应用程序，以包含症状和关注。最后,在阶段4中，将对Bone@BC应用程序的试点版本进行融合混合方法可行性研究。共有45名绝经后非转移性雌激素受体阳性乳腺癌患者将每天使用该应用程序进行症状识别，并对6个连续患者报告的结果测量结果做出反应，为期12周。最后,将进行半结构化面试。主要结果包括同意率，流失率，保留率，技术问题,和坚持，使用预先建立的可行性标准和探索可接受性的混合方法进行评估。招募了一个由5名乳腺癌女性组成的患者咨询委员会，将她们的观点和经验纳入规划，组织,实施，并在整个项目中传播研究。
结果：在提交本文时（2024年1月），在3个月的招募期内（2022年11月至2023年2月），共有23名患者被纳入第二阶段医疗审核，19名患者已被纳入阶段2，半结构化患者访谈。
结论：本方案描述了一项研究，可接受性,以及为具有内分泌方面的乳腺癌患者开发的症状管理工具Bone@BC的可用性。
背景：ClinicalTrails.govNCT05367830;https://clinicaltrials.gov/ct2/show/NCT05367830。
■DERR1-10.2196/49549。
