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NCT Number: NCT06651190

Pain Caregiver Resource (PainCaRe)

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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Key information

Conditions

Pediatric Cancer Neoplasms

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Hospital for Sick Children

Toronto, Ontario, M5G1X8, Canada

Location contact

The Hospital for Sick Children Research Ethics Board

CONTACT

[email protected]

416-813-7654 ext. 205718

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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).
  • Be able to speak and read English.

Treatment and study plan

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.

Primary outcomes

  1. Feasibility - attrition

    Time frame: 1 year

    Percent of caregivers not completing 8-week outcome measures. Criteria for feasibility: attrition <25%.

  2. Feasibility - accrual

    Time frame: 1 year

    Percent of eligible caregivers accrued per recruitment day. Criteria for feasibility: accrual >60%.

  3. Feasibility - adherence

    Time frame: 8 weeks

    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%.

  4. Acceptability

    Time frame: 8 weeks

    Measured with the Acceptability E-Scale (AES). Criteria for acceptability: mean score of 4 on each item

Secondary outcomes

  1. Child pain intensity - parent report

    Time frame: 8 weeks

    Measured by caregiver proxy report using the Brief Pain Inventory

  2. Child pain intensity - child report

    Time frame: 8 weeks

    Measured by self-report for children ≥4 years of age using the Faces Pain Scale-Revised .

  3. Child pain interference - parent report

    Time frame: 8 weeks

    Measured by parent proxy for children <8 years of age using appropriate version of PROMIS Pediatric Scale

  4. Child pain interference - child report

    Time frame: 8 weeks

    Measured by self-report for children ≥8 years of age using appropriate version of PROMIS Pediatric Scale .

  5. Child health-related quality of life - parent report

    Time frame: 8 weeks

    Measured by self-report for children <8 years of age using appropriate versions of the Pediatric Quality of Life Inventory 4.0 .

  6. Child health-related quality of life - child report

    Time frame: 8 weeks

    Measured by self-report for children <8 years of age using appropriate versions of the Pediatric Quality of Life Inventory 4.0 .

  7. Parent quality of life

    Time frame: 8 weeks

    Measured by parent report using the Caregiver Quality of Life Index - Cancer .

  8. Parent pain management self-efficacy

    Time frame: 8 weeks

    Measured by parent report using the Pain Self-Efficacy Scale .

  9. Parent care satisfaction

    Time frame: 8 weeks

    Measured by parent report using the Satisfaction with Child Healthcare Survey .

Study contacts

Contact information is provided by the study sponsor or research team.

Principal Investigator

CONTACT

[email protected]

416-813-7654 ext. 206934

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Registry information

Official study title

Building mHealth Parent Capacity to Manage Pain in Young Children With Cancer: A Pilot Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Oct 21, 2024
Registry last updated
Dec 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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