iCanCope With Pain: A Smartphone and Web Self-management Program for Adolescents and Young Adults With Chronic Pain
- Conditions
- Chronic Pain
- Interventions
- Behavioral: iCanCope app and websiteBehavioral: Attention control group
- Registration Number
- NCT02601755
- Lead Sponsor
- The Hospital for Sick Children
- Brief Summary
Chronic pain in adolescents and young adults (AYA, aged 15-25) is a common problem. Pain that is not treated properly can reduce quality of life. Programs to help AYA learn to live with and manage pain are very important. Our team is developing a smartphone application (app) and website for AYA with chronic pain. The app will help AYA to track pain, sleep, mood, activities, and exercise and help AYA set and achieve goals. The website will give information about pain and how to manage it independently. We will build the program and make sure it is easy to use and understand. We will also test if the program can be put into practice as planned and if AYA using the program feel less pain, have less limitations, and a better quality of life.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 302
- Diagnosed with chronic pain of at least 3 months duration according to medical chart
- Able to speak and read English
- Willing and able to complete online measures
- Participants are active patients at pain clinic at one of the respective participating study sites
- Have access to an Internet-connected computer according to self-report.
- Moderate to severe cognitive impairments, as assessed by reviewing medical chart and consultation with the patient's healthcare provider
- Major co-morbid psychiatric (e.g. conversion disorder, depression, anxiety disorder) illness that may impact patient's ability to understand and use the iCanCope with Pain intervention via self-report, as determined by their health care provider
- Patient from the department of haemology/oncology
- Participated in the Phase 2B iCanCope usability study
- Requires urgent CBT treatment as per their health care provider
- Individuals who have received more than 4 CBT sessions for pain management in the past 6 months, as per their health-care provider and self-report
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description iCanCope app and website iCanCope app and website Intervention: Behavioral: iCanCope app and website Attention control group Attention control group Intervention: Behavioral: Attention control group
- Primary Outcome Measures
Name Time Method Intervention fidelity 8 weeks Any issues or difficulties encountered during implementation of the intervention, control strategy, or outcome measures will be tracked throughout the study by the CRPC.
Acceptability and Satisfaction 8 weeks Participants in the intervention arm will complete the Acceptability e-scale (AES) post-intervention. In addition, a subset of participants from the intervention group will be offered to participate in a qualitative feedback interview to further explore acceptability and satisfaction of the intervention.
Engagement with Intervention 8 weeks Google Analytics will track patterns of app and website usage.
Adherence 8 weeks Adherence will be determined using Google Analytics.
Participant Accrual and Dropout Rates 8 weeks This will be centrally tracked by the clinical research project coordinator (CRPC).
- Secondary Outcome Measures
Name Time Method Pain intensity and interference 8 weeks Measured using the short form Brief Pain Inventory (BPI), a 15-item tool that measures pain intensity and impact on functioning.
Self-efficacy 8 weeks Measured with the Pain Self-Efficacy Questionnaire (PSEQ), a 10-item scale that requires patients to take their pain into account when rating their self-efficacy beliefs.
Emotional Functioning 8 weeks Measured using the Hospital Anxiety and Depression Scale (HADS), a 14-item measure for the assessment of anxiety and depressive symptoms.
Sleep Functioning 8 weeks Measured with the Insomnia Severity Index (ISI), a 7-item self-report questionnaire for assessing the nature, severity, and impact of insomnia.
Social Functioning 8 weeks Measured with the Perceived Social Support from Friends (PSS-Fr) Scale, a 20-item scale that assesses the extent to which an individual perceives that their friends fulfill their needs for support.
Pain-Related Knowledge 8 weeks Measured using a modified version of the Medical Issues, Exercise, Pain and Social Support (MEPS) questionnaire, a 27-item measure.
Patients' Global Impression of Change 8 weeks Measured using the PGIC scale, a single item rating by participants of their perceived change during the trial.
Health-Related Quality of Life 8 weeks Measured using the SF-36 Health Survey, a 36-item self-report scale with 8 subscales (Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health).
Health Care Utilization 8 weeks Measured using the Chronic Pain Healthcare Utilization Form. (modified from the Ambulatory and Home Care Record)
Adverse effects 8 weeks Will be tracked using the adverse event form.
Trial Locations
- Locations (10)
Alberta Children's Hospital
🇨🇦Calgary, Alberta, Canada
Hamilton Health Sciences
🇨🇦Hamilton, Ontario, Canada
Mount Sinai Hospital
🇨🇦Toronto, Ontario, Canada
Stollery Children's Hospital
🇨🇦Edmonton, Alberta, Canada
The Ottawa Hospital
🇨🇦Ottawa, Ontario, Canada
University of Saskatchewan
🇨🇦Saskatoon, Saskatchewan, Canada
IWK Health Centre
🇨🇦Halifax, Nova Scotia, Canada
Hospital for Sick Children
🇨🇦Toronto, Ontario, Canada
Nova Scotia Health Authority/Dalhousie University
🇨🇦Halifax, Nova Scotia, Canada
University of Alberta
🇨🇦Edmonton, Alberta, Canada