iCanCope With Pain: An Integrated Smartphone and Web Self-management Program for Adolescents and Young Adults With Chronic Pain
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 302
- Locations
- 14
- Primary Endpoint
- Intervention fidelity
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 15 Years to 25 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 been on a stable dose of medications for at least 4 weeks prior to entering the study according to medical chart
- •Have access to an Internet-connected computer according to self-report.
Exclusion Criteria
- •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
Arms & Interventions
iCanCope app and website
Intervention: Behavioral: iCanCope app and website
Intervention: iCanCope app and website (Behavioral)
Attention control group
Intervention: Behavioral: Attention control group
Intervention: Attention control group (Behavioral)
Outcomes
Primary Outcomes
Intervention fidelity
Time Frame: 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
Time Frame: 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
Time Frame: 8 weeks
Google Analytics will track patterns of app and website usage.
Adherence
Time Frame: 8 weeks
Adherence will be determined using Google Analytics.
Participant Accrual and Dropout Rates
Time Frame: 8 weeks
This will be centrally tracked by the clinical research project coordinator (CRPC).
Participant Accrual and Dropout Rates
Time Frame: 6 months
This will be centrally tracked by the clinical research project coordinator (CRPC).
Secondary Outcomes
- Pain intensity and interference(8 weeks)
- Self-efficacy(8 weeks)
- Emotional Functioning(8 weeks)
- Sleep Functioning(8 weeks)
- Social Functioning(8 weeks)
- Pain-Related Knowledge(8 weeks)
- Patients' Global Impression of Change(8 weeks)
- Health-Related Quality of Life(8 weeks)
- Health Care Utilization(8 weeks)
- Adverse effects(8 weeks)
- Pain intensity and interference(6 months)
- Self-efficacy(6 months)
- Emotional Functioning(6 months)
- Sleep Functioning(6 months)
- Social Functioning(6 months)
- Health-Related Quality of Life(6 months)
- Patients' Global Impression of Change(6 months)
- Pain-Related Knowledge(6 months)
- Health Care Utilization(6 months)
- Adverse effects(6 months)
Investigators
Jennifer Stinson
Clinician Scientist, Clinical Nurse Specialist/NP
The Hospital for Sick Children