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

Therapy-Associated Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03632343
• Other study ID #: 1000060765
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2019
• Est. completion date: December 2024

Study information

• Verified date: November 2023
• Source: The Hospital for Sick Children
• Contact: Jennifer Stinson, PhD
• Phone: 4168137654
• Email: jennifer.stinson[@]sickkids.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 222
• Est. completion date: December 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Neoplasms, Second Primary
• Therapy-Associated Cancer

Intervention

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

Locations

Country	Name	City	State
Canada	Alberta Children's Hospital	Calgary	Alberta
Canada	Stollery Children's Hospital	Edmonton	Alberta
Canada	IWK Health Centre	Halifax	Nova Scotia
Canada	McMaster Children's Hospital	Hamilton	Ontario
Canada	Children's Hospital London Health Sciences	London	Ontario
Canada	Montreal Children's Hospital	Montréal	Quebec
Canada	Children's Hospital of Eastern Ontario	Ottawa	Ontario
Canada	Hospital for Sick Children	Toronto	Ontario
Canada	BC Children's Hospital	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adolescent Demographic Questionnaire	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
Other	Parent Demographic Questionnaire	This questionnaire will ask about parents about their age, sex, ethnicity, educational attainment, and financial characteristics	Baseline
Primary	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	Patient Reported Outcomes Measurement Information System (PROMIS) Pediatric Pain Interference Short-form Scale	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
Secondary	Pediatric Quality of Life Inventory (PedsQL) 4.0	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
Secondary	Porter's scale	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
Secondary	Health Utility Index Mark 2/3 (HUI2/3)	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
Secondary	Health Services Use	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