Langius-Eklöf Ann, Craftman Åsa G, Gellerstedt Linda, Kelmendi Nazmije, Rooth Kristina, Gustavell Tina, Sundberg Kay
Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Stockholm, Sweden.
Academic Primary Health Care Center, Stockholm, Sweden.
BMJ Open. 2025 Feb 22;15(2):e090848. doi: 10.1136/bmjopen-2024-090848.
The period directly after primary treatment for breast or prostate cancer is a time when patients feel unprepared about how to manage life and address unexpected health challenges. Supportive care should focus on identifying symptoms and concerns and involving survivors in their self-care. Interventions using a blended model encompassing remote and in-person components may inform how supportive care can be organised. This protocol describes two pilot randomised controlled trials with the aim to investigate the acceptability, feasibility and potential effects of a 6 month digital and nurse-led support intervention in primary care for patients with breast or prostate cancer during the first year after primary treatment.
Two cluster randomised pilot trials including patients with breast or prostate cancer during the first year after ending primary treatment will run from 2023 in primary care centres in Region Stockholm. The trials will have an estimated sample size of 20 patients in each arm. The intervention groups receive a digital and nurse-led support intervention in combination with standard care, and the control groups receive standard care alone. To assess acceptability and feasibility, the participants in the intervention groups and the study nurses will be interviewed. Furthermore, digitally logged data and field notes by study-specific nurses will be analysed. Data collection for the potential effects of the intervention is conducted through self-reported standardised and validated questionnaires at baseline, and at 3, 6, 12, 18 and 24 months. Data entry and analyses will be blinded to the researchers. Qualitative data will be analysed with content analysis, quantitative data will be evaluated by comparing changes within and between groups.
This project was reviewed and approved by the Swedish Ethical Review Authority. Study results will be published in peer-reviewed journals and presented at scientific and professional meetings.
ClinicalTrials.gov, NCT06471452 and NCT05100121.
乳腺癌或前列腺癌初次治疗后的这段时期，患者对如何应对生活及处理意外的健康挑战往往毫无准备。支持性护理应着重于识别症状与关切，并让幸存者参与自我护理。采用包含远程和面对面要素的混合模式干预，或许能为支持性护理的组织方式提供参考。本方案描述了两项试点随机对照试验，旨在调查在初次治疗后的第一年，针对乳腺癌或前列腺癌患者在初级保健中进行为期6个月的数字化及护士主导的支持干预的可接受性、可行性及潜在效果。
两项整群随机试点试验将于2023年在斯德哥尔摩地区的初级保健中心开展，纳入初次治疗结束后第一年的乳腺癌或前列腺癌患者。预计每项试验每组有20名患者。干预组接受数字化及护士主导的支持干预并结合标准护理，对照组仅接受标准护理。为评估可接受性和可行性，将对干预组的参与者和研究护士进行访谈。此外，将分析研究特定护士的数字记录数据和现场记录。通过在基线以及第3、6、12、18和24个月时自我报告的标准化和经过验证的问卷，收集干预潜在效果的数据。数据录入和分析对研究人员设盲。定性数据将采用内容分析法进行分析，定量数据将通过比较组内和组间的变化进行评估。
本项目已由瑞典伦理审查局审查并批准。研究结果将发表在同行评审期刊上，并在科学和专业会议上展示。
ClinicalTrials.gov，NCT06471452和NCT05100121。
