Phase 3 of 4: Pilot Randomized Controlled Trial

Status:

Recruitment for feasibility testing will start fall 2016 and a definitive trial will take place in 2018.

Principal Investigator: Jennifer Stinson

Co-Investigators: Fiona Campbell, Allan Gordon, Chitra Lalloo, Jill Chorney, John Clark, Saifee Rashiq, Mark Simmonds, Lindsay Jibb, Joseph Cafazzo

Funded by: Canadian Institutes of Health Research (CIHR)

Background: Chronic pain in adolescents and young adults is a prevalent problem. Improved early self-management could help to optimize disease management and reduce pain related-disability. Smartphone apps and web-based interventions provide an innovative approach to help patient’s access ‘in the moment’ coping strategies, self-monitor symptoms, set achievable goals, and develop self-management plans. While there are web-based programs for older adults and school-age youth with chronic pain, there is no comprehensive program tailored for the unique needs of adolescents and young adults.

Objective: The overall goal of this phased program of research is to develop and evaluate the first integrated smartphone and web-based pain self-management program (iCanCope with Pain) designed for adolescents and young adults with chronic pain aged 15 to 25 years.

Procedure: The researchers will develop the iCanCope app and website and then conduct testing to ensure that it is easy to use, and efficient to complete. A qualitative usability testing approach with semi-structured, audiotaped interviews and observations will be undertaken using cycles of 15 to 21 adolescents and 15 to 21 young adults to evaluate usability and refine the prototype. Afterwards, a parallel groups pilot feasibility randomized controlled trial will be conducted with 120 adolescents and young adults with chronic pain. Following the eight -week study period, post-pilot qualitative interviews will be conducted with 20 to 30 participants from the intervention group to gain an in-depth understanding of their perceptions regarding the value and usefulness of iCanCope as a tailored pain self-management resource for 15 to 25 year olds with chronic pain. The pilot study will enable us to refine the prototype as well as inform the methodology and calculate the sample size for a definitive randomized controlled trial across all major chronic pain centres in Canada.