grant

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

Organization NEMOURS CHILDREN'S HOSPITAL, DELAWARELocation WILMINGTON, UNITED STATESPosted 2 Feb 2022Deadline 31 Jan 2027
NIHUS FederalResearch GrantFY2026Access to CareActive Follow-upAcuteAddressAnxietyBehavioralCOVID crisisCOVID epidemicCOVID pandemicCOVID-19 crisisCOVID-19 epidemicCOVID-19 eraCOVID-19 global health crisisCOVID-19 global pandemicCOVID-19 health crisisCOVID-19 pandemicCOVID-19 periodCOVID-19 public health crisisCOVID-19 yearsCancersCare GiversCare giver interventionCaregiversCaringChildhoodChildhood Cancer TreatmentChildhood CancersClinicalCognitiveCollaborationsCommunitiesConsentConsolidated Framework for Implementation ResearchConsolidated Framework for Implementation ScienceConsolidated Framework for Implementing ChangeCoping SkillsCost SavingsDataDevelopmentDissemination and ImplementationDistressEducationEducational aspectsElectronicsEmotionalEspanolFamilyFutureGoalsGrantHealth Care ProvidersHealth PersonnelHealth Services AccessibilityImmigrationImpairmentIndividualInternetInterventionInterviewInvestigatorsLanguageLatinoLatino PopulationLatino groupLatino individualLatino peopleLatinosLimited English ProficiencyLiteratureMalignant Childhood NeoplasmMalignant Childhood TumorMalignant NeoplasmsMalignant Pediatric NeoplasmMalignant Pediatric TumorMalignant TumorMalignant childhood cancerMedicalMental DepressionModelingNewly DiagnosedNursing StaffOncologyOncology CancerOutcomeParentsParticipantPatternPediatric Cancer TreatmentPediatric OncologyPersonsPhasePopulationPositionPositioning AttributePredictive FactorPredispositionProcessPsychosocial Assessment and CareRandomized, Controlled TrialsRecommendationResearchResearch PersonnelResearchersRiskRisk FactorsRoleSARS-CoV-2 epidemicSARS-CoV-2 global health crisisSARS-CoV-2 global pandemicSARS-CoV-2 pandemicSARS-coronavirus-2 epidemicSARS-coronavirus-2 pandemicSelf DirectionSelf EfficacySevere Acute Respiratory Syndrome CoV 2 epidemicSevere Acute Respiratory Syndrome CoV 2 pandemicSevere acute respiratory syndrome coronavirus 2 epidemicSevere acute respiratory syndrome coronavirus 2 pandemicSiteSpanishSpanish/EnglishSusceptibilitySymptomsSystemTestingTherapeuticWWWacceptability and feasibilityaccess to health servicesaccess to servicesaccess to treatmentaccessibility to health servicesactive followupacute symptomalleviate symptomameliorating symptomavailability of servicescancer carecancer in a childcancer in childrencancer survivalcare accesscaregiver interventionschild with cancerchildhood malignancycopingcoping strategycoronavirus disease 2019 crisiscoronavirus disease 2019 epidemiccoronavirus disease 2019 global health crisiscoronavirus disease 2019 global pandemiccoronavirus disease 2019 health crisiscoronavirus disease 2019 pandemiccoronavirus disease 2019 public health crisiscoronavirus disease crisiscoronavirus disease epidemiccoronavirus disease pandemiccoronavirus disease-19 global pandemiccoronavirus disease-19 pandemiccostcost effective interventioncost estimatecost estimationdecrease symptomdepressiondesigndesigningdetermine efficacydevelopmentaldisparity in caredisparity in health caree-HealtheHealtheffectiveness trialefficacy analysisefficacy assessmentefficacy determinationefficacy evaluationefficacy examinationefficacy testingelectronicelectronic deviceelectronic healtheligible participantevaluate efficacyevidence baseexamine efficacyfewer symptomsflexibilityflexiblefollow upfollow-upfollowed upfollowuphealth care disparityhealth care inequalityhealth care inequityhealth care personnelhealth care workerhealth providerhealth service accesshealth services availabilityhealth staffhealth workershealth workforcehealthcare employeeshealthcare staffhealthcare workforceimplementation costimplementation investmentimplementation strategyimprovedinnovateinnovationinnovativeinterestintervention deliveryintervention participantsintervention programintervention refinementlow SESlow socio-economic positionlow socio-economic statuslow socioeconomic positionlow socioeconomic statusmalignancymedical care providersmedical personnelneoplasm/cancernovelnursing personnelparentparenting education interventionparenting education programsparenting interventionparenting programparenting skill trainingparenting trainingpediatricpediatric cancerpediatric malignancypilot testpost interventionpost-trauma stresspost-traumatic stresspost-traumatic stress symptomspost-traumatic symptomsposttrauma stressposttraumatic stressposttraumatic stress symptomsposttraumatic symptomsprogramsprotective factorspsychosocialpsychosocial assessmentpsychosocial carepsychosocial outcomepsychosocial sequelaepsychosocial studiespsychosocial supportrandomized control trialreduce symptomsrelieves symptomssecondary end pointsecondary endpointservice availabilitysevere acute respiratory syndrome coronavirus 2 global health crisissevere acute respiratory syndrome coronavirus 2 global pandemicsocialsocial rolesocio-demographicssociodemographicsstrategies for implementationstressorsymptom alleviationsymptom reductionsymptom relieftelehealthtooltreatment accesstreatment providertrial comparinguptakewebweb sitewebsiteworld wide web
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Full Description

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.

Grant Number: 5R01CA258668-05
NIH Institute/Center: NIH

Principal Investigator: Kimberly Canter

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