Nursing, Zhengzhou University, Zhengzhou, Henan, China.
School of Statistics, Henan University of Economics and Law, Zhengzhou, Henan, China.
BMJ Open. 2022 Nov 28;12(11):e063921. doi: 10.1136/bmjopen-2022-063921.
Here, we provide a feasible, well-designed protocol of a randomised controlled trial for the assessment of the effects of a home-based multidisciplinary intervention on the severity of skin adverse drug reactions and health-related indicators in patients with non-small cell lung cancer (NSCLC) under epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) therapy.
The study will be a two-group, parallel randomised controlled trial conducted at patients' homes by a multidisciplinary team in Zhengzhou in Henan Province, China. Patients with NSCLC who received EGFR-TKI therapy and experienced adverse skin reactions will be randomised and receive either ordinary care or home-based multidisciplinary interventions. The intervention will be divided into an intensive stage (6 weeks) and a maintenance stage (6 weeks) with baseline and follow-up assessment. Interventions in the intensive stage will include general interventions such as health education, follow-up, behaviour guide and social support and targeted interventions such as skill training, coping with adverse drug reaction and problem-solving. The measures that will be carried out in maintenance stage are continuous interventions consisted of an intensive intervention. The multidisciplinary team will be responsible for managing skin adverse drug reactions as required at patients' homes. Data collection and analysis will be performed by researchers at baseline, the end of the sixth week of intervention and the third month after the intervention. The primary outcome is the degree of skin adverse drug reactions, while the secondary outcomes, for example, self-management ability, quality of life, outpatient visits and health economics indicators, will also be presented.
This study was reviewed and approved by the Ethics Committee of Zhengzhou University (No. ZZUIRB-2020-97). Findings will be available to patients, clinicians, nurses, pharmacists, community medical staff, funders and health policymakers through peer-reviewed publications, social media and patient support groups.
Chinese Clinical Trials Registry (ChiCTR2000040643).
在这里，我们提供了一项可行且精心设计的随机对照试验方案，旨在评估基于家庭的多学科干预对接受表皮生长因子受体酪氨酸激酶抑制剂（EGFR-TKI）治疗的非小细胞肺癌（NSCLC）患者皮肤不良反应严重程度和健康相关指标的影响。
该研究将在中国河南省郑州市由多学科团队在患者家中进行，采用两臂平行随机对照试验设计。接受 EGFR-TKI 治疗并出现皮肤不良反应的 NSCLC 患者将被随机分配接受常规护理或基于家庭的多学科干预。干预将分为强化阶段（6 周）和维持阶段（6 周），并进行基线和随访评估。强化阶段的干预包括健康教育、随访、行为指导和社会支持等一般干预，以及技能培训、应对不良反应和解决问题等针对性干预。维持阶段的干预措施是在强化阶段干预的基础上进行的持续干预。多学科团队将负责在患者家中按需管理皮肤不良反应。数据收集和分析将由基线、干预结束后第六周和干预后第三个月的研究人员进行。主要结局是皮肤不良反应的严重程度，次要结局包括自我管理能力、生活质量、门诊就诊和健康经济学指标等。
本研究已通过郑州大学伦理委员会的审查和批准（编号：ZZUIRB-2020-97）。研究结果将通过同行评审出版物、社交媒体和患者支持团体向患者、临床医生、护士、药剂师、社区医务人员、资助者和卫生政策制定者公开。
中国临床试验注册中心（ChiCTR2000040643）。
