Pain Caregiver Resource (PainCaRe)

NCT06651190 | Not Yet Recruiting

• 1 other identifier: 1000081481
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pediatric Cancer

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (9)

• Child pain intensity - parent report

  8 weeks

• Child pain intensity - child report

  8 weeks

• Child pain interference - parent report

  8 weeks

• Child pain interference - child report

  8 weeks

• Child health-related quality of life - parent report

  8 weeks

Study Arms (2)

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.

Other: Pain Caregiver Resource (PainCaRe)

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.

Interventions

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.

Intervention Arm

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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 (≥3/10) in the week preceding study enrolment (pain measured by self or caregiver proxy using a validated numerical 11-point rating scale). 2. Be able to speak and read English.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G1X8, Canada

Location

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

Principal Investigator

CONTACT

416-813-7654; lindsay.jibb@sickkids.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: DEVICE FEASIBILITY
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 16, 2024
• First Posted: October 21, 2024
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: December 15, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)