Department of Clinical Medicine, Faculty of Health Science, University of Southern Denmark, Odense, Denmark.
Department of Gynecology and Obstetrics, Odense University Hospital, Odense, Denmark.
Trials. 2023 Feb 1;24(1):74. doi: 10.1186/s13063-022-07022-0.
Follow-up programs for gynecological cancer patients are currently under revision. There is limited evidence that traditional follow-up and clinical examinations improve survival in an early-stage gynecological setting. Further, traditional follow-up programs fail to accommodate the patient's need for psychosocial and sexual supportive care and to actively involve patients and their relatives in the follow-up process. Individualized programs may replace traditional routine follow-up with fixed intervals and length. Focusing on alarm-symptoms and self-reporting may ensure detection of recurrence while allowing a continuous attention to the patient's well-being and return to daily life. In this study, a nurse-led, individualized, and need-based intervention with a specific focus on patient empowerment is tested against a standard physician-led model primarily focusing on the detection of recurrence.
The study is designed as a clinical, randomized trial conducted in one of four national onco-gynecological centers in Denmark. Patients with early-stage cervical or endometrial cancer are eligible for inclusion. The intervention group undergoes individualized, nurse-led follow-up supporting patient empowerment including repeated use of electronic patient-reported outcome measures (ePROMs) before each contact as a dialogue support tool. The follow-up contacts are mainly conducted by telephone. All project nurses attended a special training program before project start and are all well-educated and dedicated onco-gynecological nurses. The control group receives standard, physician-led, follow-up without use of ePROMs or specific focus on empowerment. The effect of the intervention is evaluated by questionnaires completed by patients at baseline (3 months after surgery) and 12, 18, and 36 months after surgery. Outcomes include empowerment using the Skill and technique subscale of the HEI-Q questionnaire as the primary outcome while fear of cancer recurrence and health-related quality of life as well as the remaining subscales of the HEI-Q represent secondary outcomes. Data is collected by use of the REDCap technology, which also provides a customized visual support function for the dialogue tool.
This study will provide new information about follow-up in early-stage gynecological cancer settings and thereby contribute to improvement of future follow-up programs. Importantly, the study will provide knowledge about the impact of specific focus on patient empowerment in follow-up programs and, further, how to facilitate empowerment among patients.
The study is registered at clinicaltrials.gov: ID no. NCT03838861. Registered on 6 February 2019. Protocol version 2, issue date 21 November 2022.
目前正在修订妇科癌症患者的随访计划。有有限的证据表明，传统的随访和临床检查并不能提高早期妇科环境下的生存率。此外，传统的随访计划未能满足患者对心理社会和性支持性护理的需求，也未能积极让患者及其家属参与随访过程。个体化方案可能会取代传统的固定间隔和时长的常规随访。关注报警症状和自我报告可能会确保复发的检测，同时持续关注患者的健康状况并使其恢复正常生活。在这项研究中，测试了一种由护士主导、个体化、基于需求的干预措施，该措施特别关注患者赋权，与主要关注复发检测的标准医生主导模式相对比。
该研究设计为在丹麦四个国家肿瘤妇科中心之一进行的临床随机试验。符合条件的患者为早期宫颈癌或子宫内膜癌患者。干预组接受个体化、护士主导的随访，支持患者赋权，包括在每次接触前重复使用电子患者报告结局测量工具（ePROMs）作为对话支持工具。随访接触主要通过电话进行。所有项目护士在项目开始前都参加了一个特别培训计划，都是受过良好教育且敬业的肿瘤妇科护士。对照组接受标准的、医生主导的随访，不使用 ePROMs 或特别关注赋权。通过患者在手术后 3 个月（手术结束后）以及手术后 12、18 和 36 个月时完成的问卷评估干预效果。结果包括使用 HEI-Q 问卷的技能和技术子量表评估的赋权，作为主要结果，而对癌症复发的恐惧和健康相关生活质量以及 HEI-Q 的其余子量表则作为次要结果。数据是通过使用 REDCap 技术收集的，该技术还为对话工具提供了定制的可视化支持功能。
本研究将提供关于早期妇科癌症环境中随访的新信息，从而有助于改进未来的随访计划。重要的是，该研究将提供关于在随访计划中特别关注患者赋权的影响的知识，以及进一步促进患者赋权的方法。
该研究在 clinicaltrials.gov 注册：注册号 NCT03838861。于 2019 年 2 月 6 日注册。方案版本 2，修订日期 2022 年 11 月 21 日。
