Comprehensive Approach to Improve Medicine Adherence in Pediatric Leukemia
提高小儿白血病用药依从性的综合方法
基本信息
- 批准号:8626018
- 负责人:
- 金额:$ 74.79万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2014
- 资助国家:美国
- 起止时间:2014-01-07 至 2014-12-31
- 项目状态:已结题
- 来源:
- 关键词:6-MercaptopurineAccountingAcculturationAcute Lymphocytic LeukemiaAddressAdherenceAdolescentAfrican AmericanAgeAreaAsiansBehavioralBeliefChildChildhoodChildhood LeukemiaChildren&aposs Oncology GroupChronicClinicalClinical Trials DesignCuesDataDevelopmentDiseaseDisease remissionDistressDoseEducationEducational InterventionElectronicsElementsErythrocytesEthnic OriginEvaluationEventExposure toFailureFamilyGeneticHigh PrevalenceHispanicsHouseholdIndividualIngestionInterventionIntervention TrialKnowledgeLifeMaintenanceMalignant Childhood NeoplasmMeasuresMediatingMediator of activation proteinMedicineMinority GroupsMonitorNot Hispanic or LatinoNucleotidesOnline SystemsOralOutcomeParenting EducationParentsPatientsPerceptionPharmaceutical PreparationsPhasePopulationPrintingPsychological reinforcementPsychosocial FactorRandomized Clinical TrialsRelapseResearch InfrastructureRiskSavingsScheduleSelf EfficacySeverity of illnessSingle ParentStagingSubgroupSymptomsSystemTextTherapeutic InterventionThioguanineTimeTranslatingarmbasebehavior changeclinically relevantcohortcost effectivedepressive symptomsfollow-uphealth beliefhealth knowledgeimprovedinteractive multimediaolder patientparental involvementpillpublic health relevancevigilance
项目摘要
Acute lymphoblastic leukemia (ALL) is the most common childhood cancer. While over 97% of children with
ALL enter remission after an initial 28-day induction period, ~20% relapse within 5 years. Furthermore,
Hispanics and African Americans are more likely to suffer relapse - a difference not entirely explained by
clinical or genetic factors. Salvage is poor, and second-line therapies are toxic and expensive. Durable first
remissions require a 2-year maintenance phase that includes daily oral self/parent-administration of 6-
mercaptopurine (6MP). Increased risk of relapse is observed in patients with low systemic exposure to 6MP
(low red cell levels of 6MP metabolite - thioguanine nucleotide [TGN]). However, the inter-individual variability
observed in red cell TGN levels could be due to failure to adhere to prescribed therapy. In a recently completed
Children's Oncology Group study (AALL03N1, R01 CA96670, PI: Bhatia), we demonstrated that the risk of
relapse was significantly higher among children with adherence rates <95%, allowing us to create a definition
of non-adherence (adherence <95%). Fifty-two percent of the relapses were attributable to non-adherence.
Sixty-six percent of African Americans, 46% of Hispanics, 48% of Asians, and 32% of non-Hispanic whites
were non-adherent (p<0.001). The worse outcome by ethnicity was mitigated after adjusting for adherence.
The most common reason for missing 6MP was forgetfulness (on part of both parents of younger children as
well as adolescent patients). Furthermore, adherent adolescent patients and their parents emphasized the
importance of parental vigilance as a strategy to overcome forgetfulness. These findings have formed the basis
for developing a comprehensive intervention package that consists of multimedia interactive patient/parent
education, and web-based medication scheduling that translates into customized printed schedules and text-
message reminders to prompt directly supervised therapy (DST) by a designated parent. Using a randomized
clinical trial design, we will study the impact of this comprehensive intervention package (IP) vs. education
alone (Edu) on adherence to oral 6MP in children with ALL who are d18 years at participation. We will examine
the modifying effect of sociodemographic/ psychosocial factors and the mediating effects of change in health
beliefs/knowledge on change in adherence with intervention, and establish the infrastructure to determine the
impact of intervention on relapse of ALL. The proposed intervention addresses a clinically relevant problem -
i.e., high prevalence of non-adherence that is associated with an increased risk of relapse in children with ALL,
and is informed by the barriers/facilitators to adherence identified in our previous studies. The intervention is
comprehensive, technologically sophisticated, yet simple, (hence disseminable) and cost-effective (savings of
~$12.6M to $32.8M/y). Successful implementation of the adherence-enhancing intervention will not only
improve survival in children with ALL, but could also have far-reaching benefits, since contemporary therapies
are increasingly incorporating oral agents in many other diseases, and non-adherence is a significant problem.
急性淋巴细胞白血病(ALL)是最常见的儿童癌症。而超过97%的儿童
项目成果
期刊论文数量(0)
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SMITA BHATIA其他文献
SMITA BHATIA的其他文献
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{{ truncateString('SMITA BHATIA', 18)}}的其他基金
Mitigating Long-term Treatment-related Morbidity in Childhood Cancer Survivors
减轻儿童癌症幸存者的长期治疗相关发病率
- 批准号:
9754794 - 财政年份:2018
- 资助金额:
$ 74.79万 - 项目类别:
Mitigating Long-term Treatment-related Morbidity in Childhood Cancer Survivors
减轻儿童癌症幸存者的长期治疗相关发病率
- 批准号:
9976463 - 财政年份:2018
- 资助金额:
$ 74.79万 - 项目类别:
Mitigating Long-term Treatment-related Morbidity in Childhood Cancer Survivors
减轻儿童癌症幸存者的长期治疗相关发病率
- 批准号:
10468239 - 财政年份:2018
- 资助金额:
$ 74.79万 - 项目类别:
Mitigating Long-term Treatment-related Morbidity in Childhood Cancer Survivors
减轻儿童癌症幸存者的长期治疗相关发病率
- 批准号:
10682635 - 财政年份:2018
- 资助金额:
$ 74.79万 - 项目类别:
Mitigating Long-term Treatment-related Morbidity in Childhood Cancer Survivors
减轻儿童癌症幸存者的长期治疗相关发病率
- 批准号:
10246837 - 财政年份:2018
- 资助金额:
$ 74.79万 - 项目类别:
Comprehensive Approach to Improve Medicine Adherence in Pediatric Leukmia
提高小儿白血病药物依从性的综合方法
- 批准号:
9390033 - 财政年份:2014
- 资助金额:
$ 74.79万 - 项目类别:
Comprehensive Approach to Improve Medicine Adherence in Pediatric Leukmia
提高小儿白血病药物依从性的综合方法
- 批准号:
8987413 - 财政年份:2014
- 资助金额:
$ 74.79万 - 项目类别:
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