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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. In 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pain Caregiver Resource (PainCaRe) | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility - attrition | Percent of caregivers not completing 8-week outcome measures. Criteria for feasibility: attrition <25%. | 1 year |
| Feasibility - accrual | Percent of eligible caregivers accrued per recruitment day. Criteria for feasibility: accrual >60%. | 1 year |
| 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 |
| Acceptability | Measured with the Acceptability E-Scale (AES). Criteria for acceptability: mean score of 4 on each item | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Child pain intensity - parent report | Measured by caregiver proxy report using the Brief Pain Inventory | 8 weeks |
| Child pain intensity - child report | Measured by self-report for children ≥4 years of age using the Faces Pain Scale-Revised . |
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Principal Investigator | Contact | 416-813-7654 | 206934 | lindsay.jibb@sickkids.ca |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Hospital for Sick Children | Toronto | Ontario | M5G1X8 | Canada |
IPD will only be only be used as part of this study
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| 8 weeks |
| Child pain interference - parent report | Measured by parent proxy for children <8 years of age using appropriate version of PROMIS Pediatric Scale | 8 weeks |
| Child pain interference - child report | Measured by self-report for children ≥8 years of age using appropriate version of PROMIS Pediatric Scale . | 8 weeks |
| Child health-related quality of life - parent report | Measured by self-report for children <8 years of age using appropriate versions of the Pediatric Quality of Life Inventory 4.0 . | 8 weeks |
| Child health-related quality of life - child report | Measured by self-report for children <8 years of age using appropriate versions of the Pediatric Quality of Life Inventory 4.0 . | 8 weeks |
| Parent quality of life | Measured by parent report using the Caregiver Quality of Life Index - Cancer . | 8 weeks |
| Parent pain management self-efficacy | Measured by parent report using the Pain Self-Efficacy Scale . | 8 weeks |
| Parent care satisfaction | Measured by parent report using the Satisfaction with Child Healthcare Survey . | 8 weeks |