Smartphone app for real-time pain management in adolescents with cancer

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

This study is testing a smartphone app that helps teenagers with cancer manage their pain in real-time, with some using the app alone and others getting extra support from a nurse.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 222 (estimated)
• Ages: 12 Years to 18 Years
• Sex: All
• Sponsor: The Hospital for Sick Children (other)
• Locations: 9 sites (Calgary, Alberta and 8 other locations)
• Trial ID: NCT03632343 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of the Pain Squad+ smartphone app designed to assist adolescents with cancer in managing their pain in real-time. Participants will use the app to report their pain levels and receive personalized advice based on an algorithm, with the option of support from a registered nurse if severe pain is reported. The study will involve 222 adolescents from nine Canadian pediatric oncology centers, who will be randomly assigned to use the app with or without nurse support over an 8-week period. Outcomes will be measured at multiple time points to assess pain intensity, quality of life, and cost-effectiveness.

Who should consider this trial

Good fit: Ideal candidates are adolescents aged 12-18 years who are currently undergoing cancer treatment and experiencing moderate to severe pain.

Not a fit: Patients with significant cognitive impairments or those not expected to survive beyond 16 weeks may not benefit from this study.

Why it matters

Potential benefit: If successful, this app could significantly improve pain management and quality of life for adolescents undergoing cancer treatment.

How similar studies have performed: Other studies have shown promise in using mobile health technologies for pain management, suggesting potential success for this novel approach.

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

Where this trial is running

Calgary, Alberta and 8 other locations

• Alberta Children's Hospital — Calgary, Alberta, Canada (NOT_YET_RECRUITING)
• Stollery Children's Hospital — Edmonton, Alberta, Canada (RECRUITING)
• BC Children's Hospital — Vancouver, British Columbia, Canada (RECRUITING)
• IWK Health Centre — Halifax, Nova Scotia, Canada (NOT_YET_RECRUITING)
• McMaster Children's Hospital — Hamilton, Ontario, Canada (RECRUITING)
• Children's Hospital London Health Sciences — London, Ontario, Canada (RECRUITING)
• Children's Hospital of Eastern Ontario — Ottawa, Ontario, Canada (RECRUITING)
• Hospital for Sick Children — Toronto, Ontario, Canada (RECRUITING)
• Montreal Children's Hospital — Montréal, Quebec, Canada (NOT_YET_RECRUITING)

Study contacts

• Study coordinator: Jennifer Stinson, PhD

Conditions: Therapy-Associated Cancer, self-management, pain, adolescents, mHealth