Therapy-Associated CancerNCT03632343
The Pain Squad+ Smartphone App To Support Real-Time Pain Management for Adolescents With Cancer
A study testing Pain Squad+ with Nurse Support and Pain Squad+ in people with Therapy-Associated Cancer, run by The Hospital for Sick Children at 9 sites in Canada.
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. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Therapy-Associated Cancer
- What is being tested?
- Pain Squad+ with Nurse Support and Pain Squad+
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 9 sitesCanada
- Study dates
- 1 Dec 2019to 30 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Canada9 sites
Alberta Children's Hospital
Calgary, Alberta, T3B 6A8
Stollery Children's Hospital
Edmonton, Alberta, T6G 2B7
IWK Health Centre
Halifax, Nova Scotia, B3K 6R8
McMaster Children's Hospital
Hamilton, Ontario, L8N 3Z5
Children's Hospital London Health Sciences
London, Ontario, N6A 5W9
Montreal Children's Hospital
Montreal, Quebec, H4A 3J1
Children's Hospital of Eastern Ontario
Ottawa, Ontario, K1H 8L1
Hospital for Sick Children
Toronto, Ontario, M5G 1X8
BC Children's Hospital
Vancouver, British Columbia, V6H 3N1
About this study
Official title: The Pain Squad+ Smartphone App To Support Real-Time Pain Management for Adolescents With Cancer: A Randomized Controlled Trial
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.
Read the 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
- Being tested
- Pain Squad+ with Nurse Support, Pain Squad+
- Keywords
- self-management, pain, adolescents, mHealth
- Medical subject headings
- Neoplasms, Second Primary, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain Squad+ with Nurse SupportOther
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+Other
Pain Squad+ smartphone app with algorithm-driven pain management advice without RN-initiated pain support.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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
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.
Measured: Baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline, 16 weeks after baseline
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.
Measured: 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)
Quality-adjusted life years (QALYs)68 will be calculated using data from the valid and reliable HUI2/3.
Measured: Baseline, 8 weeks after baseline, 16 weeks after baseline
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.
Measured: Baseline, 8 weeks after baseline, 16 weeks after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2018
- Study start1 Dec 2019
- Primary completion30 Jan 2025
- Study completion30 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Therapy-Associated CancerStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer Stinson, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03632343
- Sponsor's protocol ID
- 1000060765
- Status last verified
- Jun 2025
- First submitted
- 10 Aug 2018
- Last updated
- 29 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32184315
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Pain Squad+ Smartphone App To Support Real-Time Pain Management for Adolescents With Cancer: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03632343
- Acronym / sponsor ID
- 1000060765
- Conditions
- Therapy-Associated Cancer
- Keywords
- self-management, pain, adolescents, mHealth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 30 Jan 2025 (actual)
- Study completion
- 30 Jan 2025 (actual)
- First posted
- 15 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group A | Experimental | Other: Pain Squad+ with Nurse SupportParticipants 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. |
| Experimental Group B | Experimental | Other: Pain Squad+Participants in this arm will receive the Pain Squad+ smartphone app with algorithm-driven pain management advice but without nurse (RN)-initiated pain support. |
| 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. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pain Squad+ with Nurse SupportPain 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 | Experimental Group A |
| Pain Squad+Pain Squad+ smartphone app with algorithm-driven pain management advice without RN-initiated pain support. | Other | Experimental Group B |
Primary outcome
Brief Pain Inventory (BPI)
Time frame: 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
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.
5 secondary outcomes
Patient Reported Outcomes Measurement Information System (PROMIS) Pediatric Pain Interference Short-form Scale
Time frame: 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
Time frame: Baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline, 16 weeks after baseline
Porter's scale
Time frame: 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)
Time frame: Baseline, 8 weeks after baseline, 16 weeks after baseline
Health Services Use
Time frame: Baseline, 8 weeks after baseline, 16 weeks after baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2025.
- Derived from this study: PubMed 32184315Jibb 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pain Squad+ with Nurse Support and Pain Squad+ in people with Therapy-Associated Cancer, run by The Hospital for Sick Children at 9 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brief Pain Inventory (BPI) (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03632343, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2025.