iCanCope With Pain: A Smartphone and Web Self-management Program for Adolescents and Young Adults With Chronic Pain

NCT02601755 | Completed

• 1 other identifier: 1000047495
• Study Type: interventional
• Target: 302
• Locations: 1 country
• Sites: 10

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.

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (5)

• Participant Accrual and Dropout Rates

  This will be centrally tracked by the clinical research project coordinator (CRPC).

  6 months

• Intervention fidelity

  Any issues or difficulties encountered during implementation of the intervention, control strategy, or outcome measures will be tracked throughout the study by the CRPC.

  8 weeks

• Acceptability and Satisfaction

  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.

  8 weeks

• Engagement with Intervention

  Google Analytics will track patterns of app and website usage.

  8 weeks

• Adherence

  Adherence will be determined using Google Analytics.

  8 weeks

Secondary Outcomes (10)

• Pain intensity and interference

  6 months

• Self-efficacy

  6 months

• Emotional Functioning

  6 months

• Sleep Functioning

  6 months

• Social Functioning

  6 months

Study Arms (2)

iCanCope app and website

EXPERIMENTAL

Intervention: Behavioral: iCanCope app and website

Behavioral: iCanCope app and website

Attention control group

ACTIVE COMPARATOR

Intervention: Behavioral: Attention control group

Behavioral: Attention control group

Interventions

iCanCope app and website BEHAVIORAL

In addition to standard medical care, adolescents and young adults in the experimental group will receive access to the "iCanCope with Pain" smartphone app and website for 8 weeks. The app consists of daily pain symptom tracking (pain intensity, sleep, mood, physical activity, and fatigue), goal setting, in-the moment coping strategies, as well as a social community component. The website provides chronic pain-specific education, self-management strategies, and resources.

iCanCope app and website

Attention control group BEHAVIORAL

The control group is designed to control for the potential effects on outcomes of time, attention, smartphone and computer use during the intervention. In addition to standard medical care, adolescents and young adults in the attention control group will receive access to the "iCanCope with Pain" smartphone app (control version, with limited functionality), and a pain resource website without access to self-management strategies.

Attention control group

Eligibility Criteria

• Age: 15 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The Hospital for Sick Children: lead
• Mount Sinai Hospital, Canada: collaborator
• IWK Health Centre: collaborator
• Nova Scotia Health Authority: collaborator
• Stollery Children's Hospital: collaborator
• University of Alberta: collaborator
• Dalhousie University: collaborator
• Centre for Global eHealth Innovation: collaborator
• University of Toronto: collaborator
• University of Saskatchewan: collaborator
• Alberta Children's Hospital: collaborator
• The Ottawa Hospital: collaborator
• Hamilton Health Sciences Corporation: collaborator

Study Sites (10)

Alberta Children's Hospital

Calgary, Alberta, T3B 6A8, Canada

Location

Stollery Children's Hospital

Edmonton, Alberta, T6G 2B7, Canada

Location

University of Alberta

Edmonton, Alberta, T6G 2R7, Canada

Location

Nova Scotia Health Authority/Dalhousie University

Halifax, Nova Scotia, B3H 2E1, Canada

Location

IWK Health Centre

Halifax, Nova Scotia, B3K 6R8, Canada

Location

Hamilton Health Sciences

Hamilton, Ontario, L8N 3Z5, Canada

Location

The Ottawa Hospital

Ottawa, Ontario, K1H 8L6, Canada

Location

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

Location

Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

University of Saskatchewan

Saskatoon, Saskatchewan, Canada

Location

Related Publications (1)

• 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.

  PMID: 30664472 DERIVED

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinician Scientist, Clinical Nurse Specialist/NP

Study Record Dates

• First Submitted: November 6, 2015
• First Posted: November 10, 2015
• Study Start: April 1, 2017
• Primary Completion: August 1, 2023
• Study Completion: August 1, 2023
• Last Updated: April 20, 2026

Record last verified: 2026-04

Locations

CA (10)