Promoting Treatment Adherence in Adolescent Leukemia

促进青少年白血病的治疗依从性

• 批准号: 8123179
• 负责人: Dennis D Drotar
• 金额: $ 60.67万
• 依托单位: CINCINNATI CHILDRENS HOSP MED CTR
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-09-28 至 2013-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8123179
• 关键词: 6-Mercaptopurine; Acute Lymphocytic Leukemia; Address; Adherence; Adolescent; Behavior Therapy; Biological Assay; Caring; Child; Childhood; Chronic; Chronic Disease; Clinical; Clinical Trials; Communication; Complex; Data; Development; Dexamethasone; Disease; Electronics; Family; Intervention; Investigation; Knowledge; Lead; Maintenance Therapy; Malignant Neoplasms; Measurement; Medical; Methods; Modeling; Monitor; Morbidity - disease rate; Motivation; Oral; Outcome; Parents; Patient Self-Report; Peer Review; Pharmaceutical Preparations; Prevalence; Problem Solving; Psychosocial Assessment and Care; Randomized Clinical Trials; Relapse; Reporting; Research; Review Literature; Scientific Advances and Accomplishments; Testing; Toxic effect; Training; Treatment Protocols; clinically significant; design; disorder later incidence prevention; efficacy testing; improved; innovation; leukemia; mortality; novel; psychologic; theories; therapy design; treatment adherence

DESCRIPTION (provided by applicant): Scientific evidence suggests that many adolescents with acute lymphoblastic leukemia (ALL) do not take their medication in accord with their prescribed treatment regimens. Such nonadherence has several undesirable clinical and scientific consequences:(1) mortality and morbidity due to relapse; (2) problems in the validity of data concerning clinical trials of medication treatment, which if undetected, may create the potential for iatrogenic toxicity. However, there are little scientific data concerning the efficacy of psychological interventions that have been designed to limit the prevalence and impact of nonadherence to ALL treatment. To address this important scientific need, this study will conduct a randomized clinical trial (RCT) with 170 adolescents with ALL to evaluate a family centered, problem-solving intervention (FPST) to promote adherence to oral medication treatment. This problem solving intervention will be compared with basic psychological care. The proposed intervention model is novel in its integration of three key components derived from theory and research on adherence to treatment with pediatric chronic illnesses and cast within the developmental context of families with adolescent children. These components are: 1) training in collaborative problem solving and effective parent-adolescent communication to reduce barriers that interfere with adherence to oral medication treatment; 2) promotion of adolescents' active participation in and motivation for the management of ALL therapy; 3) emphasis on parental support and adolescent adherence to treatment that is consistent with the developmental needs of the adolescent. The primary hypothesis of the proposed study is as follows: a family-centered problem solving intervention will result in improved adherence to prescribed oral medication 6MP and Decadron among adolescents with ALL compared with basic psychosocial care. We anticipate that the proposed study will identify effective strategies to promote adherence among adolescents with ALL and will potentially lead to improved medical outcomes for these adolescents. Second, we anticipate that the principles of the intervention model will generalize beyond ALL to adolescents with other forms of cancer as well as other chronic conditions and their families. Finally, improving adherence to oral medication during maintenance therapy for adolescents who participate in clinical trials would improve the validity of the data drawn from those investigations.

描述（由申请人提供）：科学证据表明，许多患有急性淋巴细胞白血病（全部）的青少年不会按照其处方治疗方案服用药物。这种不依从性具有几种不良的临床和科学后果：（1）复发引起的死亡率和发病率； （2）数据的有效性问题有关药物治疗的临床试验，如果未被发现，可能会产生医源性毒性的潜力。但是，关于心理干预措施的功效的科学数据很少，这些数据旨在限制不遵守对所有治疗的流行和影响。为了满足这一重要的科学需求，这项研究将与170名具有所有人的青少年进行随机临床试验（RCT），以评估家庭中心，解决问题的干预措施（FPST），以促进对口服药物治疗的依从性。解决问题的干预措施将与基本的心理护理进行比较。提出的干预模型在整合了三个关键组成部分，这些关键组成部分是从理论和研究对儿科慢性疾病治疗的研究中，并在有青春期儿童家庭的发育环境中进行的。这些组成部分是：1）在协作解决问题和有效的父母交流中进行培训，以减少干扰遵守口服药物治疗的障碍； 2）促进青少年积极参与所有治疗的动机； 3）强调父母的支持和青少年遵守与青少年发展需求一致的治疗。拟议的研究的主要假设如下：与基本的社会心理护理相比，在有家庭中，以家庭为中心的解决干预措施将改善对所有有规定的口服药物6MP和DeCADRON的依从性。我们预计，拟议的研究将确定有效的策略，以促进所有人的依从性，并有可能改善这些青少年的医疗结果。其次，我们预计干预模型的原理将概括为其他形式的癌症以及其他慢性病及其家人的青少年。最后，改善参加临床试验的青少年维持治疗期间对口服药物的依从性将提高这些研究中获取的数据的有效性。