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
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
The Hospital for Sick Children |
Canada,
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 |
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