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

NCT03632343 | Completed DMC

• 1 other identifier: 1000060765
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 9

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.

Conditions

Therapy-Associated Cancer

Keywords

self-management; pain; adolescents; mHealth

Outcome Measures

Primary Outcomes (1)

• Brief Pain Inventory (BPI)

  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 Outcomes (5)

• Patient Reported Outcomes Measurement Information System (PROMIS) Pediatric Pain Interference Short-form Scale

  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

  Baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline, 16 weeks after baseline

• Porter's scale

  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)

  Baseline, 8 weeks after baseline, 16 weeks after baseline

• Health Services Use

  Baseline, 8 weeks after baseline, 16 weeks after baseline

Other Outcomes (2)

• Adolescent Demographic Questionnaire

  Baseline

• Parent Demographic Questionnaire

  Baseline

Study Arms (3)

Experimental Group A

EXPERIMENTAL

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

Experimental Group B

EXPERIMENTAL

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+

Waitlist Control

NO INTERVENTION

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.

Interventions

Pain Squad+ with Nurse Support OTHER

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 Group A

Pain Squad+ OTHER

Pain Squad+ smartphone app with algorithm-driven pain management advice without RN-initiated pain support.

Experimental Group B

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (9)

Alberta Children's Hospital

Calgary, Alberta, T3B 6A8, Canada

Location

Stollery Children's Hospital

Edmonton, Alberta, T6G 2B7, Canada

Location

BC Children's Hospital

Vancouver, British Columbia, V6H 3N1, Canada

Location

IWK Health Centre

Halifax, Nova Scotia, B3K 6R8, Canada

Location

McMaster Children's Hospital

Hamilton, Ontario, L8N 3Z5, Canada

Location

Children's Hospital London Health Sciences

London, Ontario, N6A 5W9, Canada

Location

Children's Hospital of Eastern Ontario

Ottawa, Ontario, K1H 8L1, Canada

Location

Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Montreal Children's Hospital

Montreal, Quebec, H4A 3J1, Canada

Location

Related Publications (1)

• 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.

  PMID: 32184315 DERIVED

MeSH Terms

Conditions

Neoplasms, Second Primary; Pain

Condition Hierarchy (Ancestors)

Neoplasms; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Scientist

Model Details: 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.

Study Record Dates

• First Submitted: August 10, 2018
• First Posted: August 15, 2018
• Study Start: December 1, 2019
• Primary Completion: January 30, 2025
• Study Completion: January 30, 2025
• Last Updated: June 29, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (9)