Pediatric CancerNCT06651190
Pain Caregiver Resource (PainCaRe)
A study testing Pain Caregiver Resource (PainCaRe) in people with Pediatric Cancer, run by The Hospital for Sick Children at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pediatric Cancer
- What is being tested?
- Pain Caregiver Resource (PainCaRe)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2026to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
The Hospital for Sick Children
Toronto, Ontario, M5G1X8
The Hospital for Sick Children Research Ethics Board, 416-813-7654 ext. 205718, ask.crs@sickkids.ca
About this study
Official title: Building mHealth Parent Capacity to Manage Pain in Young Children With Cancer: A Pilot Randomized Controlled 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.
- Conditions
- Pediatric Cancer
- Being tested
- Pain Caregiver Resource (PainCaRe)
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility - attrition
Percent of caregivers not completing 8-week outcome measures. Criteria for feasibility: attrition <25%.
Measured: 1 year
Feasibility - accrual
Percent of eligible caregivers accrued per recruitment day. Criteria for feasibility: accrual >60%.
Measured: 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%.
Measured: 8 weeks
Acceptability
Measured with the Acceptability E-Scale (AES). Criteria for acceptability: mean score of 4 on each item
Measured: 8 weeks
Secondary outcomes (9)
Child pain intensity - parent report
Measured by caregiver proxy report using the Brief Pain Inventory
Measured: 8 weeks
Child pain intensity - child report
Measured by self-report for children ≥4 years of age using the Faces Pain Scale-Revised .
Measured: 8 weeks
Child pain interference - parent report
Measured by parent proxy for children <8 years of age using appropriate version of PROMIS Pediatric Scale
Measured: 8 weeks
Child pain interference - child report
Measured by self-report for children ≥8 years of age using appropriate version of PROMIS Pediatric Scale .
Measured: 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 .
Measured: 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 .
Measured: 8 weeks
Parent quality of life
Measured by parent report using the Caregiver Quality of Life Index - Cancer .
Measured: 8 weeks
Parent pain management self-efficacy
Measured by parent report using the Pain Self-Efficacy Scale .
Measured: 8 weeks
Parent care satisfaction
Measured by parent report using the Satisfaction with Child Healthcare Survey .
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2024
- Study startApr 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric CancerStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lindsay Jibb, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06651190
- Sponsor's protocol ID
- 1000081481
- Status last verified
- Dec 2025
- First submitted
- 16 Oct 2024
- Last updated
- 15 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will only be only be used as part of this study
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Building mHealth Parent Capacity to Manage Pain in Young Children With Cancer: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06651190
- Acronym / sponsor ID
- 1000081481
- Conditions
- Pediatric Cancer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- Apr 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 21 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Other: Pain Caregiver Resource (PainCaRe)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. |
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Intervention Arm |
Primary outcome
Feasibility - attrition
Time frame: 1 year
Percent of caregivers not completing 8-week outcome measures. Criteria for feasibility: attrition <25%.
Feasibility - accrual
Time frame: 1 year
Percent of eligible caregivers accrued per recruitment day. Criteria for feasibility: accrual >60%.
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%.
Acceptability
Time frame: 8 weeks
Measured with the Acceptability E-Scale (AES). Criteria for acceptability: mean score of 4 on each item
9 secondary outcomes
Child pain intensity - parent report
Time frame: 8 weeks
Child pain intensity - child report
Time frame: 8 weeks
Child pain interference - parent report
Time frame: 8 weeks
Child pain interference - child report
Time frame: 8 weeks
Child health-related quality of life - parent report
Time frame: 8 weeks
Child health-related quality of life - child report
Time frame: 8 weeks
Parent quality of life
Time frame: 8 weeks
Parent pain management self-efficacy
Time frame: 8 weeks
Parent care satisfaction
Time frame: 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2025.
- Individual participant dataSharing planned: No. IPD will only be only be used as part of this study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pain Caregiver Resource (PainCaRe) in people with Pediatric Cancer, run by The Hospital for Sick Children at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Principal Investigator (416-813-7654 ext. 206934, lindsay.jibb@sickkids.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility - attrition (time frame: 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2025.