Arts Lindy P J, van de Poll-Franse Lonneke V, van den Berg Sanne W, Prins Judith B, Husson Olga, Mols Floortje, Brands-Nijenhuis Angelique V M, Tick Lidwine, Oerlemans Simone
Department of Research, Netherlands Comprehensive Cancer Organisation, PO Box 19079, 3501 DB, Utrecht, the Netherlands.
Division of Psychosocial Research and Epidemiology, Netherlands Cancer Institute, Amsterdam, the Netherlands.
Trials. 2017 Apr 28;18(1):199. doi: 10.1186/s13063-017-1943-2.
Patients with lymphoma are at risk of experiencing adverse physical and psychosocial problems from their cancer and its treatment. Regular screening of these symptoms by the use of patient-reported outcomes (PROs) could increase timely recognition and adequate symptom management. Moreover, self-management interventions intend to enhance knowledge and skills and empower patients to better manage their disease and related problems. The objective of the Lymphoma InterVEntion (LIVE) trial is to examine whether feedback to patients on their PROs and access to a web-based, self-management intervention named Living with lymphoma will increase self-management skills and satisfaction with information, and reduce psychological distress.
METHODS/DESIGN: The LIVE randomised controlled trial consists of three arms: (1) standard care, (2) PRO feedback, and (3) PRO feedback and the Living with lymphoma intervention. Patients who have been diagnosed with Hodgkin lymphoma, non-Hodgkin lymphoma, including chronic lymphocytic leukaemia, as registered in the Netherlands Cancer Registry in various hospitals will be selected for participation. Patients are invited via their haemato-oncologist 6 to 15 months after diagnosis. The PRO feedback includes a graphical overview of patients' own symptom and functioning scores and an option to compare their scores with those of other patients with lymphoma and a normative population of the same age and sex. The Living with lymphoma intervention is based on cognitive behavioural therapy components and includes information, assignments, assessments, and videos. Changes in outcomes from baseline to 16 weeks, 12, and 24 months post intervention will be measured. Primary outcomes are self-management skills, satisfaction with information, and psychological distress. Secondary outcomes are health-related quality of life, illness perceptions, fatigue, and health care use.
DISCUSSION/DESIGN: The results of the LIVE trial will provide novel insights into whether access to PRO feedback and the Living with lymphoma intervention will be effective in increasing self-management skills and satisfaction with information, and reducing distress. The LIVE trial is embedded in a population-based registry, which provides a unique setting to ascertain information on response, uptake, and characteristics of patients with lymphoma in web-based intervention(s). When effective, PRO feedback and Living with lymphoma could serve as easily and widely accessible interventions for coping with lymphoma.
Netherlands Trial Register, identifier NTR5953 . Registered on 14 July 2016.
淋巴瘤患者因其癌症及其治疗而有经历不良身体和心理社会问题的风险。通过使用患者报告结局（PROs）定期筛查这些症状可提高及时识别和适当的症状管理。此外，自我管理干预旨在增强知识和技能，并使患者有能力更好地管理其疾病及相关问题。淋巴瘤干预（LIVE）试验的目的是检验向患者反馈其PROs以及使用名为“与淋巴瘤共存”的基于网络的自我管理干预措施是否会提高自我管理技能和对信息的满意度，并减轻心理困扰。
方法/设计：LIVE随机对照试验包括三个组：（1）标准护理，（2）PRO反馈，以及（3）PRO反馈和“与淋巴瘤共存”干预。将选择在荷兰各医院癌症登记处登记的已被诊断为霍奇金淋巴瘤、非霍奇金淋巴瘤（包括慢性淋巴细胞白血病）的患者参与。患者在诊断后6至15个月通过血液肿瘤学家被邀请参与。PRO反馈包括患者自身症状和功能评分的图形概述，以及将其评分与其他淋巴瘤患者和相同年龄及性别的正常人群评分进行比较的选项。“与淋巴瘤共存”干预基于认知行为疗法组件，包括信息、任务、评估和视频。将测量从基线到干预后16周、12个月和24个月结局的变化。主要结局是自我管理技能、对信息的满意度和心理困扰。次要结局是与健康相关的生活质量、疾病认知、疲劳和医疗保健使用。
讨论/设计：LIVE试验的结果将为获取PRO反馈和“与淋巴瘤共存”干预措施在提高自我管理技能和对信息的满意度以及减轻困扰方面是否有效提供新的见解。LIVE试验嵌入在一个基于人群的登记处中，这为确定淋巴瘤患者在基于网络的干预措施中的反应、接受情况和特征信息提供了独特的环境。如果有效，PRO反馈和“与淋巴瘤共存”可作为应对淋巴瘤的易于获取且广泛可用的干预措施。
荷兰试验注册库，标识符NTR5953。于2016年7月14日注册。
