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A randomized controlled trial of eSCCIP: An eHealth psychosocial intervention for English and Spanish speaking parents of children with cancer

A randomized controlled trial of eSCCIP: An eHealth psychosocial intervention for English and Spanish speaking parents of children with cancer
eSCCIP 的随机对照试验:针对英语和西班牙语癌症儿童父母的电子健康心理社会干预
批准号:
10560593
负责人:
Kimberly Canter
金额:
$63.17万
依托单位国家:
美国
项目类别:
财政年份:
2022
资助国家:
美国
项目状态:
未结题
起止时间:
2022-02-02 至 2027-01-31
关键词:
AcuteAddressAnxietyBehavioralCOVID-19 pandemicCaregiversCaringChildhoodChildhood Cancer TreatmentClinicalCognitiveCollaborationsCommunitiesConsentConsolidated Framework for Implementation ResearchCoping SkillsCost SavingsDataDevelopmentDissemination and ImplementationDistressEducationElectronicsEmotionalFamilyFutureGoalsGrantHealth PersonnelHealth Services AccessibilityImmigrationImpairmentIndividualInternetInterventionInterviewLanguageLatinoLatino PopulationLimited English ProficiencyLiteratureMalignant Childhood NeoplasmMalignant NeoplasmsMedicalMental DepressionModelingNewly DiagnosedNursing StaffOncologyOutcomeParentsParticipantPatternPediatric OncologyPersonsPhasePopulationPositioning AttributePredictive FactorPredispositionProcessPsychosocial Assessment and CareRandomized, Controlled TrialsRecommendationResearchResearch PersonnelRiskRisk FactorsRoleSelf DirectionSelf EfficacySiteSymptomsSystemTestingTherapeuticacceptability and feasibilityacute symptomcancer carecancer survivalcaregiver interventionscopingcostcost effective interventioncost estimatedesigneHealtheffectiveness trialefficacy evaluationefficacy testingeligible participantevidence baseflexibilityfollow-uphealth care disparityimplementation costimplementation strategyimprovedinnovationinterestintervention deliveryintervention participantsintervention programintervention refinementlow socioeconomic statusnovelpilot testpost interventionpost-traumatic stresspost-traumatic symptomsprogramsprotective factorspsychosocialreduce symptomssecondary endpointsocialsociodemographicsstressortelehealthtooltrial comparinguptakeweb site

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英文摘要
The psychosocial needs and risks of children with cancer and their families are well-documented in the literature, including the increased risk of parental distress, posttraumatic stress, and anxiety. There is a critical need to provide evidence-based psychosocial care to parents and caregivers of children with cancer (PCCC), although many challenges exist regarding in-person intervention delivery. eHealth interventions represent an exciting potential opportunity to address many of the barriers to in-person intervention delivery in this population, but are not yet widely utilized in pediatric psychosocial cancer care. The COVID-19 pandemic has further illuminated the need for flexible, acceptable, and accessible eHealth psychosocial interventions. The Electronic Surviving Cancer Competently Intervention Program (eSCCIP) is an innovative eHealth intervention for PCCC, delivered through a combination of self-guided interactive online content and telehealth follow-up with a therapist. eSCCIP aims to decrease symptoms of acute distress, anxiety, and posttraumatic stress while improving coping abilities by delivering evidence-based therapeutic content through a flexible, easily accessible eHealth tool. The intervention is delivered to one or two PCCC per family, but content is designed to apply to the whole family system. eSCCIP is grounded in principles of cognitive-behavioral and family systems therapy and is adapted from two efficacious in-person interventions for caregivers of children with cancer, the Surviving Cancer Competently Intervention Program (SCCIP) and the Surviving Cancer Competently Intervention Program – Newly Diagnosed (SCCIP-ND). eSSCIP has been rigorously developed through a stakeholder-engaged development process involving close collaboration with PCCC, content experts in pediatric oncology and eHealth, and web design and development experts. A Spanish language adaptation of eSCCIP, El Programa Electronico de Intervencion para Superar Cancer Competentemente (eSCCIP-SP), has recently been developed following a rigorous process and is now ready for testing as well. The self-guided online modules of eSCCIP/eSCCIP-SP feature a mix of didactic video content, novel multifamily video discussion groups featuring parents of children with cancer, and hands-on interactive activities. Pilot testing is currently underway with promising initial results. The objective of the proposed study is to test eSCCIP/eSCCIP-SP in a rigorous, multisite RCT compared to an education control condition. The primary study endpoint is a reduction in acute distress from baseline to post-intervention, with secondary endpoints focused on reductions in symptoms of posttraumatic stress and anxiety ,and improvements in coping self- efficacy and cognitive coping. Data will be collected at three timepoints (baseline, post-intervention, and three- month follow-up). An additional, exploratory aim will be focused on implementation strategies and potential costs and cost-savings of eSCCIP/eSCCIP-SP, laying the groundwork for future trials focused on dissemination and implementation, stepped-care models, and intervention refinement.
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A randomized controlled trial of eSCCIP: An eHealth psychosocial intervention for English and Spanish speaking parents of children with cancer
Intervention Methods: Provision and Connection through Technology (IMPACT)
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