Health TrialsbyHealthPanel

Pain Caregiver Resource (PainCaRe)

ConditionPediatric Cancer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorThe Hospital for Sick Children

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Pain Caregiver Resource (PainCaRe)

    Other intervention

    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.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Intervention ArmExperimental treatment 1 intervention
Group B: Control ArmNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Feasibility - attrition

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

Time frame
1 year
2

Feasibility - accrual

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

Time frame
1 year
3

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%.

Time frame
8 weeks
4

Acceptability

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

Time frame
8 weeks

Secondary outcomes

1

Child pain intensity - parent report

Measured by caregiver proxy report using the Brief Pain Inventory

Time frame
8 weeks
2

Child pain intensity - child report

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

Time frame
8 weeks
3

Child pain interference - parent report

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

Time frame
8 weeks
4

Child pain interference - child report

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

Time frame
8 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The Hospital for Sick Children

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: