Clinical trial NCT03632343: The Pain Squad+ Smartphone App To Support Real-Time Pain Management for Adolescents With Cancer
Official title: The Pain Squad+ Smartphone App To Support Real-Time Pain Management for Adolescents With Cancer: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Therapy-Associated Cancer
Keywords: self-management
pain
adolescents
mHealth
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2018-08-15
Enrollment: 222
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This will be a multi-centre, waitlist group controlled, data analyst blinded, 3-arm parallel-group superiority randomized controlled trial (RCT) with 1:1:1 allocation. Randomization will be stratified by recruitment site to account for differences in care across sites49 with block sizes of 6 and 9 within each stratum. This trial has been designed along the pragmatic end of the pragmatic-explanatory continuum. Our approach to study eligibility criteria, intervention intensity, and participant adherence will determine intervention effect under real-world conditions.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Brief Pain Inventory (BPI)
timeFrame: 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 outcomes:
measure: Patient Reported Outcomes Measurement Information System (PROMIS) Pediatric Pain Interference Short-form Scale
timeFrame: Baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline, 16 weeks after baseline
measure: Pediatric Quality of Life Inventory (PedsQL) 4.0
timeFrame: Baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline, 16 weeks after baseline
measure: Porter's scale
timeFrame: Baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline, 16 weeks after baseline
measure: Health Utility Index Mark 2/3 (HUI2/3)
timeFrame: Baseline, 8 weeks after baseline, 16 weeks after baseline
measure: Health Services Use
timeFrame: Baseline, 8 weeks after baseline, 16 weeks after baseline
Other outcomes:
measure: Adolescent Demographic Questionnaire
timeFrame: Baseline
measure: Parent Demographic Questionnaire
timeFrame: Baseline
Locations:
city: Calgary
country: Canada
facility: Alberta Children's Hospital
state: Alberta
city: Edmonton
country: Canada
facility: Stollery Children's Hospital
state: Alberta
city: Vancouver
country: Canada
facility: BC Children's Hospital
state: British Columbia
city: Halifax
country: Canada
facility: IWK Health Centre
state: Nova Scotia
city: Hamilton
country: Canada
facility: McMaster Children's Hospital
state: Ontario
city: London
country: Canada
facility: Children's Hospital London Health Sciences
state: Ontario
city: Ottawa
country: Canada
facility: Children's Hospital of Eastern Ontario
state: Ontario
city: Toronto
country: Canada
facility: Hospital for Sick Children
state: Ontario
city: Montréal
country: Canada
facility: Montreal Children's Hospital
state: Quebec
Study officials:
References:
citation: Jibb L, Nathan PC, Breakey V, Fernandez C, Johnston D, Lewis V, McKillop S, Patel S, Sabapathy C, Strahlendorf C, Victor JC, Moretti ME, Nguyen C, Hundert A, Cassiani C, El-Khechen Richandi G, Insull H, Hamilton R, Fang G, Kuczynski S, Stinson J. Pain Squad+ smartphone app to support real-time pain treatment for adolescents with cancer: protocol for a randomised controlled trial. BMJ Open. 2020 Mar 16;10(3):e037251. doi: 10.1136/bmjopen-2020-037251.