Columbia University School of Nursing, New York, NY, USA.
Herbert Irving Comprehensive Cancer Center, Columbia University Irving Medical Center, New York, NY, USA.
BMC Health Serv Res. 2022 Jun 28;22(1):832. doi: 10.1186/s12913-022-08201-0.
The study purpose is to describe trajectories of financial distress for parents of children (ages 1-14.9 years) with newly diagnosed acute lymphoblastic leukemia (ALL). The secondary aim is to identify multilevel factors (child, parent, household, treating institution) that influence change in financial distress over time.
The study uses a prospective cohort design, repeated measurements, and mixed methods. The settings are Children's Oncology Group (COG) institutions participating in the National Cancer Institute Community Oncology Research Program (NCORP). Eligible participants are English- and/or Spanish-speaking parents or legal guardians (hereafter "parents") of index children. Parents are asked to complete a survey during their child's induction (T1) and maintenance therapy (T2), and near treatment completion (T3). Study surveys include items about (a) the child's cancer and clinical course, (b) parental socio-economic status, financial distress and financial coping behaviors, and (c) household material hardships. At least 15 parents will be invited to participate in an optional semi-structured interview. NCORP institutions that enroll at least one parent must complete an annual survey about institution resources that could influence parental financial distress.
The results will inform future interventions to mitigate financial distress for parents of children diagnosed with ALL and could be instructive beyond this disease group.
This trial was initially registered with the NCI Clinical Trial Reporting Program ID: NCI-2021-03,567 on June 16, 2021. The study can be found on clinicaltrials.gov, Identifier NCT04928599 .
本研究旨在描述新诊断为急性淋巴细胞白血病（ALL）的 1-14.9 岁儿童的父母的财务困境轨迹。次要目的是确定影响财务困境随时间变化的多水平因素（儿童、父母、家庭、治疗机构）。
本研究采用前瞻性队列设计、重复测量和混合方法。研究地点为参与国家癌症研究所社区肿瘤学研究计划（NCORP）的儿童肿瘤学组（COG）机构。符合条件的参与者为指数儿童的英语和/或西班牙语的父母或法定监护人（以下简称“父母”）。在诱导治疗（T1）和维持治疗（T2）以及接近治疗结束时（T3），父母被要求完成一份调查。研究调查包括以下方面的项目：（a）儿童的癌症和临床过程；（b）父母的社会经济地位、财务困境和财务应对行为；（c）家庭物质困难。将邀请至少 15 位家长参加可选的半结构化访谈。招募至少一位家长的 NCORP 机构必须完成一份关于可能影响父母财务困境的机构资源的年度调查。
结果将为缓解 ALL 儿童父母的财务困境提供未来干预措施的信息，并可能为该疾病组以外的人群提供指导。
该试验最初于 2021 年 6 月 16 日在 NCI 临床试验报告计划 ID：NCI-2021-03,567 下注册。该研究可在 clinicaltrials.gov 上找到，标识符为 NCT04928599。
