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

NCT ID: NCT03632343

Last Updated: 2025-06-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-01
• Study Completion Date: 2025-01-30

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.

Conditions

Therapy-Associated Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Pain Squad+ with Nurse Support

Intervention Type: 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 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.

Group Type: EXPERIMENTAL

Pain Squad+

Intervention Type: OTHER

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

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Pain Squad+

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Hospital for Sick Children

OTHER

Sponsor Role: lead

Responsible Party

Jennifer Stinson

Senior Scientist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Alberta Children's Hospital

Calgary, Alberta, Canada

Stollery Children's Hospital

Edmonton, Alberta, Canada

BC Children's Hospital

Vancouver, British Columbia, Canada

IWK Health Centre

Halifax, Nova Scotia, Canada

McMaster Children's Hospital

Hamilton, Ontario, Canada

Children's Hospital London Health Sciences

London, Ontario, Canada

Children's Hospital of Eastern Ontario

Ottawa, Ontario, Canada

Hospital for Sick Children

Toronto, Ontario, Canada

Montreal Children's Hospital

Montreal, Quebec, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 32184315 (View on PubMed)

Other Identifiers

1000060765

Identifier Type: -

Identifier Source: org_study_id