Wolff Josefine, Wuelfing Pia, Koenig Alexander, Ehrl Brigitte, Damsch Jana, Smollich Martin, Baumann Freerk Theeagnus, Harbeck Nadia, Wuerstlein Rachel
Breast Center, Department of Gynecology and Obstetrics, and Comprehensive Cancer Center Munich, Ludwig-Maximilians-University, University Hospital, Munich, Germany.
PINK! gegen Brustkrebs GmbH, Department Clinical Research, Hamburg, Germany.
Breast Care (Basel). 2023 Oct;18(5):354-365. doi: 10.1159/000531495. Epub 2023 Jun 16.
This pilot study aimed to investigate the effects of using an app-based certified medical product named PINK! on breast cancer patients and survivors. The objectives were to measure psychological distress, physical activity, and therapy-related fatigue of patients using PINK! to identify trends and develop a study design for a subsequent multicentric proof of efficacy RCT.
PINK! offers individualized, evidence-based therapy and side-effect management, mindfulness-based stress reduction, nutritional and psychological education, physical activity tracking, and motivational exercises to implement lifestyle changes sustainably in daily routine. A prospective, intraindividual RCT was performed with = 60 patients in 2021 at Comprehensive Cancer Center Munich. Patients with BC were included independent of the stage of diseases. The intervention group got access to PINK! over 12 weeks. Control group served as a waiting-list comparison to "standard of care."
Primary efficacy variable analysis revealed a relative average decrease of 32.9% in psychological distress, which corresponds to a statistically significant reduction ( < 0.001) within 12 weeks compared to the control group. Linear regressions within usage groups showed a correlation of high app usage and a reduction of psychological distress. Fatigue data presented a statistically significant antifatigue efficacy ( < 0.001) and physical activity increased by 63.9%.
App-based supportive care offers a promising, low-threshold, and cost-efficient opportunity to improve psychological well-being, quality of life, fatigue, and physical activity. More research is needed to implement eHealth solutions in clinical cancer care.
这项试点研究旨在调查使用一款名为PINK!的基于应用程序的认证医疗产品对乳腺癌患者及幸存者的影响。目标是测量使用PINK!的患者的心理困扰、身体活动及与治疗相关的疲劳，以确定趋势并为后续多中心疗效验证随机对照试验制定研究设计。
PINK!提供个性化、循证治疗及副作用管理、基于正念的减压、营养和心理教育、身体活动追踪以及激励练习，以在日常生活中可持续地实现生活方式改变。2021年在慕尼黑综合癌症中心对60例患者进行了一项前瞻性个体内随机对照试验。纳入的乳腺癌患者不考虑疾病分期。干预组在12周内可使用PINK!。对照组作为“标准护理”的等待列表对照。
主要疗效变量分析显示，心理困扰相对平均下降32.9%，与对照组相比，在12周内有统计学显著降低（<0.001）。使用组内的线性回归显示，应用程序高使用量与心理困扰减轻之间存在相关性。疲劳数据显示有统计学显著的抗疲劳效果（<0.001），身体活动增加了63.9%。
基于应用程序的支持性护理为改善心理健康、生活质量、疲劳和身体活动提供了一个有前景、低门槛且经济高效的机会。在临床癌症护理中实施电子健康解决方案还需要更多研究。
