Clinical Health Promotion Centre, The Parker Institute, Bispebjerg-Frederiksberg Hospital, Part of Copenhagen University Hospitals, 2000, Frederiksberg, Denmark.
Department of Urology 2112, Copenhagen University Hospital, Rigshospitalet, 2100, Copenhagen, Denmark.
Trials. 2022 Apr 21;23(1):333. doi: 10.1186/s13063-022-06272-2.
There is a large unused potential for risk reduction in the preoperative period via effective lifestyle intervention targeting co-existing risky lifestyles: Smoking, malNutrition, obesity, risky Alcohol intake and insufficient Physical activity (SNAP). This trial compares the efficacy of the integrated STRONG programme with standard care on preoperative risk reduction and secondly on SNAP factor improvement and frailty, postoperative complications and quality of life. A nested interview study explores the patient preferences and the multi-perspective view of patients, relatives and health professionals.
In total, 42 surgical patients with ≥1 SNAP factor are allocated to individually tailored STRONG programme or usual care during adjuvant chemotherapy prior to radical bladder cancer surgery. The STRONG programme has ≥6 weekly sessions with patient education, motivational and pharmaceutical support. It is based on intensive smoking and alcohol cessation interventions reporting perioperative quit rates > 50%. Surgical risk reduction is measured as ≥1 step for 1 or more risky lifestyles on the ASA-score, secondly as having no risky SNAP factors, and as any SNAP improvement. The outcomes are validated by measurements and biomarkers. Postoperative complications are categorised according to the Clavien-Dindo classification. Health-related quality of life is measured by EQ-5D. The patients are followed up after 6 weeks at surgery and 6 weeks and 6 months postoperatively. A representative sample of the participants, their relatives and the clinical staff are interviewed until data saturation. Transcription, triangulated analyses and data management are conducted using NVivo computer software.
The surgical agenda is characterised by fixed dates for surgery focusing on clear risk reduction within a short time. This requires a clinical useful lifestyle intervention programme with a high effect and coverage as well as containing all SNAP factors and tailored to individual needs. The STRONG programme seems to meet these requirements. After development in multi-professional collaboration, STRONG is delivered by a specially trained nurse as part of the surgical patient journey. Overall, this study will bring important new knowledge about risk reduction in a frail patient group undergoing major cancer surgery.
Registration at www.clintrials.gov ( NCT04088968 ) The manuscript form from https://trialsjournal.biomedcentral.com/bmc/journal and the SPIRIT guidelines are followed.
通过针对并存的高危生活方式（吸烟、营养不良、肥胖、高危饮酒和体力活动不足）的有效生活方式干预，术前可大大降低风险。本试验比较了综合 STRONG 方案与标准护理对术前风险降低的疗效，其次是对 SNAP 因素改善和虚弱、术后并发症和生活质量的影响。一项嵌套式访谈研究探讨了患者的偏好以及患者、亲属和卫生专业人员的多角度观点。
总共纳入 42 例存在≥1 个 SNAP 因素的手术患者，在接受根治性膀胱癌手术前的辅助化疗期间，按个体化 STRONG 方案或常规护理进行分配。STRONG 方案包括≥6 次每周的患者教育、动机和药物支持。它基于强化的戒烟和戒酒干预，报告围手术期戒烟率>50%。手术风险降低的测量标准为 ASA 评分上≥1 个高危生活方式的步骤，其次为无高危 SNAP 因素，以及任何 SNAP 改善。通过测量和生物标志物验证结果。根据 Clavien-Dindo 分类对术后并发症进行分类。使用 EQ-5D 测量健康相关生活质量。患者在术后 6 周、6 周和 6 个月进行随访。对有代表性的参与者、其亲属和临床工作人员进行访谈，直到数据饱和。使用 NVivo 计算机软件进行转录、三角分析和数据管理。
手术议程的特点是手术日期固定，重点是在短时间内明确降低风险。这需要一个临床有用的生活方式干预方案，具有高效果和覆盖率，并包含所有 SNAP 因素，并针对个体需求进行调整。STRONG 方案似乎满足了这些要求。在多专业合作中开发后，STRONG 由经过专门培训的护士在手术患者旅程中提供。总的来说，这项研究将为接受重大癌症手术的虚弱患者群体的风险降低带来重要的新知识。
在 www.clintrials.gov 上注册（NCT04088968）。使用来自 https://trialsjournal.biomedcentral.com/bmc/journal 的稿件表格和 SPIRIT 指南。
