The Pain Squad+ Smartphone App To Support Real-Time Pain Management for Adolescents With Cancer

November 20, 2023 updated by: Jennifer Stinson, The Hospital for Sick Children

The Pain Squad+ Smartphone App To Support Real-Time Pain Management for Adolescents With Cancer: A Randomized Controlled Trial

Pain negatively affects the quality of life of adolescents with cancer (AWC). It can also represent a high cost to the healthcare system and families. In response, our team has built a smartphone-based app, called Pain Squad+, which can give AWC real-time advice to manage their pain. The app uses pain diaries and personalized pain advice plus support from a registered nurse to give real-time pain management in all settings. This study will look at the impact of Pain Squad+, with or without the nurse support, on AWC health quality and healthcare costs over time.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Pain negatively affects the quality of life (QOL) of adolescents with cancer (AWC), slows cancer recovery, and results in negative long-term health effects. Pain is also significant cost to the healthcare system and families. To address this problem, the study investigators have developed and used a phased-approach to test a smartphone-based app, called Pain Squad+. Using this app AWC report the pain they have and the app provides AWC with advice on how to treat this pain based on an algorithm our team developed. An email is also sent to a nurse if an AWC reports severe pain 3 times in a row. The nurse then contacts the AWC to assist in treating pain. This project will test the effect of the Pain Squad+ app, with and without nurse help, on treating pain and other pain-related health issues and managing costs associated with pain care, when compared to AWC not using the app. Investigators will enroll 222 AWC recruited from 9 Canadian pediatric oncology care centres into a 3-group randomized controlled trial. AWC in the experimental groups will be asked to use Pain Squad+ for 8 weeks (with or without nurse involvement) and all groups will complete pain-related outcome measures at baseline, 2-, 4-, 8-, and 16-weeks. The primary study outcome will be pain intensity. The secondary study outcomes will be (a) pain interference; (b) QOL; (c) pain self-efficacy; and (d) cost effectiveness and utility. Investigators will use established statistical methods to analyze the health and cost data collected over the course of this study. A real-time and cost effective way to address the problem of pain in AWC is needed. Pain Squad+ can improve pain treatment and QOL for AWC as well as decrease costs incurred by families and the healthcare system. If effective, the Pain Squad+ as a model of technology-assisted care may represent a way to improve the QOL for a range of Canadian patients by treating a variety of physical and psychological symptoms the moment they occur.

Study Type

Interventional

Enrollment (Estimated)

222

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T3B 6A8
        • Not yet recruiting
        • Alberta Children's Hospital
        • Contact:
      • Edmonton, Alberta, Canada, T6G 2B7
    • British Columbia
      • Vancouver, British Columbia, Canada, V6H 3N1
        • Recruiting
        • BC Children's Hospital
        • Contact:
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3K 6R8
    • Ontario
      • Hamilton, Ontario, Canada, L8N 3Z5
        • Recruiting
        • McMaster Children's Hospital
        • Contact:
      • London, Ontario, Canada, N6A 5W9
        • Recruiting
        • Children's Hospital London Health Sciences
        • Contact:
      • Ottawa, Ontario, Canada, K1H 8L1
        • Recruiting
        • Children's Hospital of Eastern Ontario
        • Contact:
      • Toronto, Ontario, Canada, M5G 1X8
        • Recruiting
        • Hospital for Sick Children
        • Contact:
    • Quebec
      • Montréal, Quebec, Canada, H4A 3J1
        • Not yet recruiting
        • Montreal Children's Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • aged 12-18 years,
  • are able to speak and read English,
  • are diagnosed with cancer (all disease types),
  • are on active therapy,
  • have an average self-reported pain score of ≥3/10 measured using an 11-point numerical rating scale (NRS) over the preceding week, and
  • have an English-speaking and reading caregiver who is willing and able to complete outcome measures related to healthcare encounters

Exclusion Criteria:

  • with significant cognitive impairments or co-morbid illnesses (as determined by their medical team) that would limit interaction with Pain Squad+ or outcome measure assessment,
  • who are currently participating in other pain management studies, and
  • who are not expected to survive past 16 weeks as determined by their oncologist

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Group A
Participants in this arm will receive the Pain Squad+ smartphone app with algorithm-driven pain management advice registered nurse (RN)-initiated pain support. Email alerts related to clinically important incoming pain reports (3 consecutive reports of pain >3/10) will be sent to the study RN who will contact the healthcare team at the participants' home center to initiate clinician-driven intervention, which may be outside of the scope of the self-management algorithm. The RN will contact the participant within 12 hours of receiving the alert, including on weekends.
Other: Pain Squad+ with Nurse Support
Pain Squad+ smartphone app with algorithm-driven pain management advice registered nurse (RN)-initiated pain support. Email alerts related to clinically important incoming pain reports (3 consecutive reports of pain >3/10) will be sent to the study RN who will contact the healthcare team at the participants' home center to initiate clinician-driven intervention, which may be outside of the scope of the self-management algorithm. The RN will contact the participant within 12 hours of receiving the alert, including on weekends.
Experimental: Experimental Group B
Participants in this arm will receive the Pain Squad+ smartphone app with algorithm-driven pain management advice but without nurse (RN)-initiated pain support.
Other: Pain Squad+
Pain Squad+ smartphone app with algorithm-driven pain management advice without RN-initiated pain support.
No Intervention: Waitlist Control
Participants in this arm will be waitlisted to receive their choice of experimental group condition within 1 month of completing all post-study outcome measures.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Brief Pain Inventory (BPI)
Time Frame: Change from baseline Brief Pain Inventory measure at 4 time points: 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline, 16 weeks after baseline
The BPI assesses current pain and 'worst', 'least', and 'average' pain in the preceding week using an 11-point numerical rating scale (NRS) with verbal anchors 'no pain' at 0 and 'pain as bad as you can imagine' at 10. Item scores are averaged to give a Pain Intensity Summary Score.
Change from baseline Brief Pain Inventory measure at 4 time points: 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline, 16 weeks after baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Reported Outcomes Measurement Information System (PROMIS) Pediatric Pain Interference Short-form Scale
Time Frame: Baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline, 16 weeks after baseline
The PROMIS instrument is a valid 8- item scale assessing the impact of pain on function. Higher scores represent greater interference with function. We will use the established Bonferroni correction to account for serial comparisons.
Baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline, 16 weeks after baseline
Pediatric Quality of Life Inventory (PedsQL) 4.0
Time Frame: Baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline, 16 weeks after baseline
The PedsQL 4.0 is a valid and reliable 23-item instrument not specific to pain. It is comprised of 4 subscales (physical functioning, emotional functioning, social functioning and school functioning), which are summed to provide a total score. Higher scores represent better QOL. We will separately analyze the subscales and total scale scores of the PedsQL.
Baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline, 16 weeks after baseline
Porter's scale
Time Frame: Baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline, 16 weeks after baseline
Porter's scale which assesses self-efficacy for managing pain, symptoms, and function in cancer patients. This 16-item scale includes a valid and reliable 5-item subscale assessing cancer pain management self-efficacy with higher scores indicating more certainty and is adapted from a scale that has been successfully administered to adolescents.
Baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline, 16 weeks after baseline
Health Utility Index Mark 2/3 (HUI2/3)
Time Frame: Baseline, 8 weeks after baseline, 16 weeks after baseline
Quality-adjusted life years (QALYs)68 will be calculated using data from the valid and reliable HUI2/3.
Baseline, 8 weeks after baseline, 16 weeks after baseline
Health Services Use
Time Frame: Baseline, 8 weeks after baseline, 16 weeks after baseline
Direct healthcare costs will include the intervention and costs for health service use by AWC during the trial. Family out-of-pocket expenses, indirect costs due to lost productivity, and health service use will be ascertained using standardized customized data collection forms.
Baseline, 8 weeks after baseline, 16 weeks after baseline

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adolescent Demographic Questionnaire
Time Frame: Baseline
This questionnaire will ask about socio-economic, demographic, and disease information for descriptive purposes. It will also obtain information on potential moderators of observed treatment effects: AWC age, sex, ethnicity, school grade, diagnosis, stage/risk, relapse-status, treatment-type, date of diagnosis, co-morbid conditions and medications, and pain history.
Baseline
Parent Demographic Questionnaire
Time Frame: Baseline
This questionnaire will ask about parents about their age, sex, ethnicity, educational attainment, and financial characteristics
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Hospital for Sick Children

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2019

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

August 10, 2018

First Submitted That Met QC Criteria

August 14, 2018

First Posted (Actual)

August 15, 2018

Study Record Updates

Last Update Posted (Actual)

November 22, 2023

Last Update Submitted That Met QC Criteria

November 20, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1000060765

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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