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

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

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 Overview

• Status: Completed
• Conditions: Chronic Pain
• Intervention / Treatment: Behavioral: iCanCope app and website; Behavioral: Attention control group

• Study Type: Interventional
• Enrollment (Actual): 302
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T3B 6A8
      • Alberta Children's Hospital
    • Edmonton, Alberta, Canada, T6G 2B7
      • Stollery Children's Hospital
    • Edmonton, Alberta, Canada, T6G 2R7
      • University of Alberta
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3K 6R8
      • IWK Health Centre
    • Halifax, Nova Scotia, Canada, B3H 2E1
      • Nova Scotia Health Authority/Dalhousie University
  • Ontario
    • Hamilton, Ontario, Canada, L8N 3Z5
      • Hamilton Health Sciences
    • Ottawa, Ontario, Canada, K1H 8L6
      • The Ottawa Hospital
    • Toronto, Ontario, Canada, M5G 1X8
      • Hospital for Sick Children
    • Toronto, Ontario, Canada, M5G 1X5
      • Mount Sinai Hospital
  • Saskatchewan
    • Saskatoon, Saskatchewan, Canada
      • University of Saskatchewan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 25 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: iCanCope app and website; Intervention: Behavioral: iCanCope app and website	Behavioral: iCanCope app and website; 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.
Active Comparator: Attention control group; Intervention: Behavioral: Attention control group	Behavioral: Attention control group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant Accrual and Dropout Rates	This will be centrally tracked by the clinical research project coordinator (CRPC).	8 weeks
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain intensity and interference	Measured using the short form Brief Pain Inventory (BPI), a 15-item tool that measures pain intensity and impact on functioning.	8 weeks
Self-efficacy	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.	8 weeks
Emotional Functioning	Measured using the Hospital Anxiety and Depression Scale (HADS), a 14-item measure for the assessment of anxiety and depressive symptoms.	8 weeks
Sleep Functioning	Measured with the Insomnia Severity Index (ISI), a 7-item self-report questionnaire for assessing the nature, severity, and impact of insomnia.	8 weeks
Social Functioning	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.	8 weeks
Health-Related Quality of Life	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).	8 weeks
Patients' Global Impression of Change	Measured using the PGIC scale, a single item rating by participants of their perceived change during the trial.	8 weeks
Pain-Related Knowledge	Measured using a modified version of the Medical Issues, Exercise, Pain and Social Support (MEPS) questionnaire, a 27-item measure.	8 weeks
Health Care Utilization	Measured using the Chronic Pain Healthcare Utilization Form. (modified from the Ambulatory and Home Care Record)	8 weeks
Adverse effects	Will be tracked using the adverse event form.	8 weeks

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2017
• Primary Completion (Actual): August 1, 2023
• Study Completion (Actual): August 1, 2023

Study Registration Dates

• First Submitted: November 6, 2015
• First Submitted That Met QC Criteria: November 6, 2015
• First Posted (Estimated): November 10, 2015

Study Record Updates

• Last Update Posted (Estimated): November 22, 2023
• Last Update Submitted That Met QC Criteria: November 20, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: 1000047495

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No