Clinical trial NCT02601755: iCanCope With Pain: A Smartphone and Web Self-management Program for Adolescents and Young Adults With Chronic Pain
Official title: iCanCope With Pain: An Integrated Smartphone and Web Self-management Program for Adolescents and Young Adults With Chronic Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
Collaborators: name: Mount Sinai Hospital, Canada
name: IWK Health Centre
name: Nova Scotia Health Authority
name: Stollery Children's Hospital
name: University of Alberta
name: Dalhousie University
name: Centre for Global eHealth Innovation
name: University of Toronto
name: University of Saskatchewan
name: Alberta Children's Hospital
name: The Ottawa Hospital
name: Hamilton Health Sciences Corporation
First posted: 2015-11-10
Enrollment: 302
Sex: ALL
Minimum age (years): 15
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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 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
* 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

Primary outcomes:
measure: Participant Accrual and Dropout Rates
timeFrame: 8 weeks
measure: Intervention fidelity
timeFrame: 8 weeks
measure: Acceptability and Satisfaction
timeFrame: 8 weeks
measure: Engagement with Intervention
timeFrame: 8 weeks
measure: Adherence
timeFrame: 8 weeks
Secondary outcomes:
measure: Pain intensity and interference
timeFrame: 8 weeks
measure: Self-efficacy
timeFrame: 8 weeks
measure: Emotional Functioning
timeFrame: 8 weeks
measure: Sleep Functioning
timeFrame: 8 weeks
measure: Social Functioning
timeFrame: 8 weeks
measure: Health-Related Quality of Life
timeFrame: 8 weeks
measure: Patients' Global Impression of Change
timeFrame: 8 weeks
measure: Pain-Related Knowledge
timeFrame: 8 weeks
measure: Health Care Utilization
timeFrame: 8 weeks
measure: Adverse effects
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Alberta Children's Hospital
state: Alberta
city: Edmonton
country: Canada
facility: Stollery Children's Hospital
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
city: Halifax
country: Canada
facility: Nova Scotia Health Authority/Dalhousie University
state: Nova Scotia
city: Halifax
country: Canada
facility: IWK Health Centre
state: Nova Scotia
city: Hamilton
country: Canada
facility: Hamilton Health Sciences
state: Ontario
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
city: Toronto
country: Canada
facility: Hospital for Sick Children
state: Ontario
city: Saskatoon
country: Canada
facility: University of Saskatchewan
state: Saskatchewan
Study officials:
References:
citation: Lalloo C, Hundert A, Harris L, Pham Q, Campbell F, Chorney J, Dick B, Simmonds M, Cafazzo J, Stinson J. Capturing Daily Disease Experiences of Adolescents With Chronic Pain: mHealth-Mediated Symptom Tracking. JMIR Mhealth Uhealth. 2019 Jan 17;7(1):e11838. doi: 10.2196/11838.