Langius-Eklöf Ann, Crafoord Marie-Therése, Christiansen Mats, Fjell Maria, Sundberg Kay
Department of Neurobiology, Care Sciences and Society, Division of Nursing, Karolinska Institutet, 141 83 Huddinge, Stockholm, Sweden.
BMC Cancer. 2017 Jul 4;17(1):466. doi: 10.1186/s12885-017-3450-y.
Cancer patients are predominantly treated as out-patients and as they often experience difficult symptoms and side effects it is important to facilitate and improve patient-clinician communication to support symptom management and self-care. Although the number of projects within supportive cancer care evaluating mobile health is increasing, few evidence-based interventions are described in the literature and thus there is a need for good quality clinical studies with a randomised design and sufficient power to guide future implementations. An interactive information and communications technology platform, including a smartphone/computer tablet app for reporting symptoms during cancer treatment was created in collaboration with a company specialising in health care management. The aim of this paper is to evaluate the effects of using the platform for patients with breast cancer during neo adjuvant chemotherapy treatment and patients with locally advanced prostate cancer during curative radiotherapy treatment. The main hypothesis is that the use of the platform will improve clinical management, reduce costs, and promote safe and participatory care.
The study is a prospective, randomised, controlled trial for each patient group and it is based on repeated measurements. Patients are consecutively included and randomised. The intervention groups report symptoms via the app daily, during treatment and up to three weeks after end of treatment, as a complement to standard care. Patients in the control groups receive standard care alone. Outcomes targeted are symptom burden, quality of life, health literacy (capacity to understand and communicate health needs and promote healthy behaviours), disease progress and health care costs. Data will be collected before and after treatment by questionnaires, registers, medical records and biomarkers. Lastly, participants will be interviewed about participatory and meaningful care.
Results will generate knowledge to enhance understanding about how to develop person-centred care using mobile technology. Supporting patients' involvement in their care to identify problems early, promotes more timely initiation of necessary treatment. This can benefit patients treated outside the hospital setting in regard to maintaining their safety.
June 12 2015 NCT02477137 (Prostate cancer) and June 12 2015 NCT02479607 (Breast cancer).
癌症患者主要作为门诊病人接受治疗，由于他们经常经历各种不适症状和副作用，因此促进并改善患者与临床医生之间的沟通对于支持症状管理和自我护理至关重要。尽管评估移动健康在支持性癌症护理中的项目数量不断增加，但文献中描述的基于证据的干预措施却很少，因此需要开展高质量的随机设计且具有足够效力的临床研究，以指导未来的实施。我们与一家专门从事医疗保健管理的公司合作，创建了一个交互式信息通信技术平台，其中包括一款用于在癌症治疗期间报告症状的智能手机/平板电脑应用程序。本文旨在评估该平台在新辅助化疗期间对乳腺癌患者以及在根治性放疗期间对局部晚期前列腺癌患者的使用效果。主要假设是该平台的使用将改善临床管理、降低成本并促进安全且参与性强的护理。
本研究针对每个患者组进行前瞻性、随机、对照试验，且基于重复测量。患者被连续纳入并随机分组。干预组在治疗期间及治疗结束后长达三周内每天通过应用程序报告症状，作为标准护理的补充。对照组患者仅接受标准护理。目标结局包括症状负担、生活质量、健康素养（理解和沟通健康需求以及促进健康行为的能力）、疾病进展和医疗保健成本。数据将在治疗前后通过问卷、登记册、医疗记录和生物标志物进行收集。最后，将对参与者进行关于参与性和有意义护理的访谈。
研究结果将产生相关知识，以增进对如何利用移动技术开展以患者为中心的护理的理解。支持患者参与自身护理以便早期发现问题，有助于更及时地启动必要治疗。这对于在院外接受治疗的患者在维护其安全方面可能有益。
2015年6月12日，NCT02477137（前列腺癌）和2015年6月12日，NCT02479607（乳腺癌）。
