University of Cologne, Faculty of Medicine and University Hospital Cologne, Institute of Medical Sociology, Health Services Research and Rehabilitation Science, Chair of Health Services Research, Cologne, Germany
University Hospital Bonn, Department for Psychosomatic Medicine and Psychotherapy, Center for Health Communication and Health Services Research, Bonn, Germany.
BMJ Open. 2023 Aug 11;13(8):e067868. doi: 10.1136/bmjopen-2022-067868.
While maintaining or restoring work ability after a cancer diagnosis is an essential aim of the rehabilitation process for working-age patients, problems can arise during the return to work (RTW) or when retaining work. Counselling could provide support for patients with or after cancer with employment-related questions (eg, questions related to RTW and work retention). Outpatient psychosocial cancer counselling centres in Germany offer counselling on work-related questions; however, resources for this are limited. This protocol presents a feasibility study of an intensified needs-based counselling intervention that supports those seeking employment-related advice.
The CARES (cancer rehabilitation support by cancer counselling centres) project is a feasibility study for a newly developed counselling intervention. The intervention is being developed as part of the project and piloted in about 20 outpatient cancer counselling centres. The CARES study has a quasi-experimental pre-post design with a control cohort. First, patients who undergo regular counselling are recruited. Second, after the counsellors have been trained for the newly developed intervention, participants for the intervention group are recruited from the cancer counselling centres. Quantitative and formative evaluations will be performed in accordance with the existing guidelines. The quantitative evaluation comprises three patient surveys (at the beginning of the counselling process, 3 months into the counselling process and, for the intervention group, at the end of the counselling process) and routine data of the counselling process. The formative evaluation includes interviews with patients, counsellors and other stakeholders, as well as participatory observations of counselling sessions.
Approval has been obtained from the ethics committee of the Medical Faculty of the University Bonn (061/22; 09.04.2022). A data protection concept ensures adherence to data protection regulations for the handled data. The dissemination strategies include discussing the results with the cancer counselling centres.
German Clinical Trials Register (DRKS00028121); Pre-results.
在癌症诊断后维持或恢复工作能力是工作年龄段患者康复过程的重要目标，但在重返工作岗位（RTW）或保留工作时可能会出现问题。咨询可以为癌症患者或癌症后患者提供与就业相关的问题（例如，与 RTW 和工作保留相关的问题）提供支持。德国的门诊心理社会癌症咨询中心提供与工作相关问题的咨询；然而，这种资源是有限的。本方案介绍了一项强化基于需求的咨询干预措施的可行性研究，该措施支持那些寻求就业相关建议的人。
CARES（癌症咨询中心支持癌症康复）项目是一项针对新开发咨询干预措施的可行性研究。该干预措施是作为该项目的一部分开发的，并在大约 20 个门诊癌症咨询中心进行试点。CARES 研究采用准实验前后设计和对照组。首先，招募接受常规咨询的患者。其次，在咨询员接受新开发干预措施的培训后，从癌症咨询中心招募干预组的参与者。将根据现有指南进行定量和形成性评估。定量评估包括三个患者调查（咨询过程开始时、咨询过程进行 3 个月时以及干预组在咨询过程结束时）和咨询过程的常规数据。形成性评估包括对患者、咨询员和其他利益相关者的访谈，以及对咨询会议的参与式观察。
已获得波恩大学医学系伦理委员会的批准（061/22；2022 年 4 月 9 日）。数据保护概念确保遵守处理数据的数据保护法规。传播策略包括与癌症咨询中心讨论结果。
德国临床试验注册处（DRKS00028121）；预结果。
