[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100566131":3},{"organization":4,"outcomesModule":7,"designInfo":51,"detailedDescription":50,"studyPopulation":50,"armGroups":59,"interventions":70,"overallOfficials":50,"centralContacts":75,"locations":82,"responsibleParty":100,"collaborators":50,"id":103,"slug":50,"hasResults":104,"nctId":105,"briefTitle":72,"officialTitle":106,"acronym":50,"eligibilityCriteria":107,"healthyVolunteers":104,"sex":108,"minAge":50,"maxAge":50,"enrollmentInfo":109,"targetDuration":50,"studyType":112,"phases":113,"briefSummary":115,"conditions":116,"keywords":50,"overallStatus":118,"whyStopped":50,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":128},{"fullName":5,"class":6},"The Hospital for Sick Children","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":23,"otherOutcomes":50},[9,13,16,20],{"measure":10,"description":11,"timeFrame":12},"Feasibility - attrition","Percent of caregivers not completing 8-week outcome measures. Criteria for feasibility: attrition \\\u003C25%.","1 year",{"measure":14,"description":15,"timeFrame":12},"Feasibility - accrual","Percent of eligible caregivers accrued per recruitment day. Criteria for feasibility: accrual \\>60%.",{"measure":17,"description":18,"timeFrame":19},"Feasibility - adherence","Adherence to the intervention will be measured using the Analytics Platform to Evaluate Effective Engagement (APEEE) platform, a proprietary analytics software measuring the number of once-daily pain assessments completed and engagement with pain treatment guidance. Criteria for feasibility: adherence to twice-daily pain reporting \\>65%.","8 weeks",{"measure":21,"description":22,"timeFrame":19},"Acceptability","Measured with the Acceptability E-Scale (AES). Criteria for acceptability: mean score of 4 on each item",[24,27,30,33,36,39,41,44,47],{"measure":25,"description":26,"timeFrame":19},"Child pain intensity - parent report","Measured by caregiver proxy report using the Brief Pain Inventory",{"measure":28,"description":29,"timeFrame":19},"Child pain intensity - child report","Measured by self-report for children ≥4 years of age using the Faces Pain Scale-Revised .",{"measure":31,"description":32,"timeFrame":19},"Child pain interference - parent report","Measured by parent proxy for children \\\u003C8 years of age using appropriate version of PROMIS Pediatric Scale",{"measure":34,"description":35,"timeFrame":19},"Child pain interference - child report","Measured by self-report for children ≥8 years of age using appropriate version of PROMIS Pediatric Scale .",{"measure":37,"description":38,"timeFrame":19},"Child health-related quality of life - parent report","Measured by self-report for children \\\u003C8 years of age using appropriate versions of the Pediatric Quality of Life Inventory 4.0 .",{"measure":40,"description":38,"timeFrame":19},"Child health-related quality of life - child report",{"measure":42,"description":43,"timeFrame":19},"Parent quality of life","Measured by parent report using the Caregiver Quality of Life Index - Cancer .",{"measure":45,"description":46,"timeFrame":19},"Parent pain management self-efficacy","Measured by parent report using the Pain Self-Efficacy Scale .",{"measure":48,"description":49,"timeFrame":19},"Parent care satisfaction","Measured by parent report using the Satisfaction with Child Healthcare Survey .",null,{"allocation":52,"interventionModel":53,"interventionModelDescription":50,"primaryPurpose":54,"observationalModel":50,"timePerspective":50,"maskingInfo":55},"RANDOMIZED","PARALLEL","DEVICE_FEASIBILITY",{"masking":56,"maskingDescription":50,"whoMasked":57},"SINGLE",[58],"INVESTIGATOR",[60,66],{"label":61,"type":62,"description":63,"interventionNames":64},"Intervention Arm","EXPERIMENTAL","Participants will download the PainCaRe app from the web to their personal phone either virtually or in-person. Parents will receive app-based notifications to complete a pain assessment report once-daily. Assessments not completed will be marked as \"missed\". Parents will also have the ability to complete ad hoc pain assessments as needed.\n\nIn response to the assessment indicating a child has pain, evidence-based, algorithm-driven pharmacological, physical, or psychological pain treatment guidance will be provided. This guidance is tailored to the age and developmental stage of the child.",[65],"Other: Pain Caregiver Resource (PainCaRe)",{"label":67,"type":68,"description":69,"interventionNames":50},"Control Arm","NO_INTERVENTION","Parents randomized to the control arm (non-intervention group) will not be assigned to the PainCaRe app and their child will continue to receive standard medical and pain care.",[71],{"type":6,"name":72,"description":73,"armGroupLabels":74,"otherNames":50},"Pain Caregiver Resource (PainCaRe)","The purpose of the PainCaRe mobile health app is to support parents of young children with cancer (between the ages of 2-11 years) to manage their cancer-related pain at home. The app will ask caregivers to completed a brief 6-question pain assessment once daily and complete ad hoc assessments as needed. Based on the results of the pain assessment, real-time, evidence-based pain management suggestions, including will be provided to parents. The purpose of the pilot randomized controlled trial (RCT) is to evaluate the feasibility of implementing PainCaRe in a future RCT. Please find attached the study protocol for reference.",[61],[76],{"name":77,"role":78,"phone":79,"phoneExt":80,"email":81},"Principal Investigator","CONTACT","416-813-7654","206934","lindsay.jibb@sickkids.ca",[83],{"facility":5,"status":50,"city":84,"state":85,"zip":86,"country":87,"countryCode":88,"cosmosGeoPoint":89,"geoPoint":94,"contacts":95},"Toronto","Ontario","M5G1X8","Canada","CA",{"type":90,"coordinates":91},"Point",[92,93],-79.39864,43.70643,{"lat":93,"lon":92},[96],{"name":97,"role":78,"phone":79,"phoneExt":98,"email":99},"The Hospital for Sick Children Research Ethics Board","205718","ask.crs@sickkids.ca",{"type":101,"investigatorFullName":102,"investigatorTitle":77,"investigatorAffiliation":5,"oldNameTitle":50,"oldOrganization":50},"PRINCIPAL_INVESTIGATOR","Lindsay Jibb","100566131",false,"NCT06651190","Building mHealth Parent Capacity to Manage Pain in Young Children With Cancer: A Pilot Randomized Controlled Trial","1. Be the primary caregiver, or person assuming the majority of care activities, for a child aged 2-11 years undergoing cancer treatment and experiencing above mild pain (≥3\u002F10) in the week preceding study enrolment (pain measured by self or caregiver proxy using a validated numerical 11-point rating scale).\n2. Be able to speak and read English.","ALL",{"count":110,"type":111},40,"ESTIMATED","INTERVENTIONAL",[114],"NA","Pain is a problem for children with cancer, especially when they are outside of the hospital setting. Younger children with cancer are particularly vulnerable to undermanaged pain because of their inability to self-report pain and their reliance on parents for treatment. One method to help these children to get the best care possible is through the use of smartphone-based mHealth solutions. Smartphone apps can provide treatment advice to patients experiencing pain in real-time and in any environment. This research will use a phased and user-centered approach with family caregivers to co-design and co-evaluate the new cancer Pain Caregiver Resource (PainCaRe) app to achieve the following aims: (1) high-fidelity software development and usability refinement; (2) evaluation of trial feasibility and preliminary effectiveness in a pilot randomized controlled trial (RCT); and (3) systematic analysis of caregiver app usage patterns to refine PainCaRe for optimal engagement prior to a future RCT.",[117],"Pediatric Cancer","NOT_YET_RECRUITING","2025-12-05",{"date":121,"type":122},"2025-12-15","ACTUAL",{"date":124,"type":111},"2026-04",{"date":126,"type":111},"2027-04",{"name":5,"class":6},1]