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Completed

NCT Number: NCT02601755

iCanCope With Pain: A 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.

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Key information

Conditions

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

Age range

15 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alberta Children's Hospital, Calgary, Alberta, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Participant Accrual and Dropout Rates

    Time frame: 6 months

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

  2. 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.

  3. 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.

  4. Engagement with Intervention

    Time frame: 8 weeks

    Google Analytics will track patterns of app and website usage.

  5. Adherence

    Time frame: 8 weeks

    Adherence will be determined using Google Analytics.

Secondary outcomes

  1. Pain intensity and interference

    Time frame: 6 months

    Measured using the short form Brief Pain Inventory (BPI), a 15-item tool that measures pain intensity and impact on functioning.

  2. Self-efficacy

    Time frame: 6 months

    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.

  3. Emotional Functioning

    Time frame: 6 months

    Measured using the Hospital Anxiety and Depression Scale (HADS), a 14-item measure for the assessment of anxiety and depressive symptoms.

  4. Sleep Functioning

    Time frame: 6 months

    Measured with the Insomnia Severity Index (ISI), a 7-item self-report questionnaire for assessing the nature, severity, and impact of insomnia.

  5. Social Functioning

    Time frame: 6 months

    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.

  6. Health-Related Quality of Life

    Time frame: 6 months

    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).

  7. Patients' Global Impression of Change

    Time frame: 6 months

    Measured using the PGIC scale, a single item rating by participants of their perceived change during the trial.

  8. Pain-Related Knowledge

    Time frame: 6 months

    Measured using a modified version of the Medical Issues, Exercise, Pain and Social Support (MEPS) questionnaire, a 27-item measure.

  9. Health Care Utilization

    Time frame: 6 months

    Measured using the Chronic Pain Healthcare Utilization Form. (modified from the Ambulatory and Home Care Record)

  10. Adverse effects

    Time frame: 6 months

    Will be tracked using the adverse event form.

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2023
Study completion
2023
First posted
Nov 10, 2015
Registry last updated
Apr 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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