A Healthy Weight Intervention for Family Stress during the Early Phases of ALL Treatment: NOURISH-ALL
ALL 治疗早期针对家庭压力的健康体重干预:NOURISH-ALL
基本信息
- 批准号:10808650
- 负责人:
- 金额:$ 20.93万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2023
- 资助国家:美国
- 起止时间:2023-09-15 至 2028-08-31
- 项目状态:未结题
- 来源:
- 关键词:Acute Lymphocytic LeukemiaAddressAdverse eventBehavior TherapyBehavioralBehavioral ModelCancer ControlCancer SurvivorChildChild HealthChildhood Acute Lymphocytic LeukemiaChildhood Cancer TreatmentChronicClinicalClinical TrialsCognitiveCognitive TherapyConduct Clinical TrialsCoping SkillsDataDevelopment PlansDiagnosisDietary intakeDisease-Free SurvivalDisparityDoseEatingEducationEligibility DeterminationEnrollmentEnvironmentFamilyFeedbackFutureGlucocorticoidsGoalsHealthHealth PromotionHealth behaviorInterventionInterviewKnowledgeMalignant Childhood NeoplasmMalignant NeoplasmsMentorshipModelingNewly DiagnosedObesityOutcomeParticipantPatientsPharmaceutical PreparationsPhasePhysical activityPlayPreparationProcessPrognosisProtocols documentationResearchResearch PersonnelRoleScientistSepsisShapesStressStress and CopingStructureSurvival RateSystemTargeted ResearchTestingTimeToxic effectTrainingTreatment ProtocolsTreatment outcomeUnhealthy DietWeightWeight GainWorkYouthacceptability and feasibilityarmbehavior changecancer diagnosiscareercareer developmentclinical practicecopingdesignefficacy testingefficacy trialevidence baseexcessive weight gainexperiencefamily structurefamily supportfollow-uphealthy weighthigh riskimprovedintervention refinementleukemia treatmentmultidisciplinarypatient engagementpatient orientedphysical inactivitypilot testpreventpreventive interventionrecruitrelapse riskresearch and developmentretention ratesedentaryskill acquisitionskillsstress managementstressorsurvivorshiptherapy developmenttreatment disparityweight gain prevention
项目摘要
PROJECT SUMMARY/ABSTRACT
Excessive weight gain leading to obesity is common during the early phases of pediatric acute lymphoblastic
leukemia (ALL) treatment, and results in higher risk of relapse, lower event-free survival rates, and more adverse
events during treatment. Yet, effective preventive interventions for excessive weight gain during the early phases
of ALL treatment are lacking. Aligned with NCI priorities, the long-term objective of this work is to mitigate weight-
related disparities in pediatric cancer treatment outcomes. Guided by the ORBIT Model of Behavioral
Intervention Development, the goal of this proposal is to adapt, refine, and pilot test a family-based health
promotion intervention that aims to curb excessive weight gain among youth with ALL by integrating support for
family coping with stress during the early phases of ALL treatment. Given that ALL is most prevalent in young
children, families play an essential role in shaping youth’s health behaviors during treatment. In Aim 1a, the PI
and her mentorship team will adapt an existing family-based health promotion intervention (NOURISH-T) to meet
the specific needs of families of youth in the early phases of ALL treatment (NOURISH-ALL). Adaptations will
incorporate family systems and cognitive behavioral intervention components to support healthy family coping
with diagnosis and treatment stress. Additional, patient-centered adaptations regarding intervention content and
delivery will be informed by semi-structured input from families and youth with ALL (n=10 at minimum) and
multidisciplinary clinical experts (n=6 at minimum) until thematic saturation is reached. In Aim 1b, the
investigative team will iteratively refine the NOURISH-ALL intervention through sequential testing with families
and youth with ALL (n=5 at minimum) and structured participant feedback. Intervention refinement will be
ongoing until >80% feasibility and acceptability ratings are achieved or until n=10 families complete the
intervention and provide structured feedback. In Aim 2, the adapted and refined NOURISH-ALL intervention will
be pilot tested in a single arm trial with 20 newly recruited families of youth in the early phases of ALL treatment.
The research team will assess key components of participant engagement to inform the future, fully powered
clinical trial, including recruitment rate, retention at treatment completion, and intended intervention dose
received. By incorporating tailored strategies for health promotion during the early phases of ALL treatment, the
proposed study seeks to shift clinical practice paradigms to prevent weight-related disparities in treatment
outcomes. This K08 will provide opportunities for the PI to acquire skills and knowledge in: (1) the early phases
of ALL treatment, (2) scientific adaptation and refinement of family-based behavior change interventions, and (3)
the conduct of clinical trials focused on behavior change interventions. The research and career development
plan, supported by a multidisciplinary team of experts in a rich academic environment, will support the PI’s
transition to independence as a cancer control scientist who possesses the skills and expertise needed to adapt
evidence-based behavior change interventions to the pediatric cancer treatment context.
项目总结/文摘
项目成果
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