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

Primary Purpose

Chronic Pain

Status
Active
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
iCanCope app and website
Attention control group
Sponsored by
The Hospital for Sick Children
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain

Eligibility Criteria

15 Years - 25 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Alberta Children's Hospital
  • Stollery Children's Hospital
  • University of Alberta
  • Nova Scotia Health Authority/Dalhousie University
  • IWK Health Centre
  • Hamilton Health Sciences
  • The Ottawa Hospital
  • Mount Sinai Hospital
  • Hospital for Sick Children
  • University of Saskatchewan

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

iCanCope app and website

Attention control group

Arm Description

Intervention: Behavioral: iCanCope app and website

Intervention: Behavioral: Attention control group

Outcomes

Primary Outcome Measures

Participant Accrual and Dropout Rates
This will be centrally tracked by the clinical research project coordinator (CRPC).
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.
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.
Engagement with Intervention
Google Analytics will track patterns of app and website usage.
Adherence
Adherence will be determined using Google Analytics.

Secondary Outcome Measures

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.
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.
Emotional Functioning
Measured using the Hospital Anxiety and Depression Scale (HADS), a 14-item measure for the assessment of anxiety and depressive symptoms.
Sleep Functioning
Measured with the Insomnia Severity Index (ISI), a 7-item self-report questionnaire for assessing the nature, severity, and impact of insomnia.
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.
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).
Patients' Global Impression of Change
Measured using the PGIC scale, a single item rating by participants of their perceived change during the trial.
Pain-Related Knowledge
Measured using a modified version of the Medical Issues, Exercise, Pain and Social Support (MEPS) questionnaire, a 27-item measure.
Health Care Utilization
Measured using the Chronic Pain Healthcare Utilization Form. (modified from the Ambulatory and Home Care Record)
Adverse effects
Will be tracked using the adverse event form.

Full Information

First Posted
November 6, 2015
Last Updated
October 24, 2022
Sponsor
The Hospital for Sick Children
Collaborators
Mount Sinai Hospital, Canada, IWK Health Centre, Nova Scotia Health Authority, Stollery Children's Hospital, University of Alberta, Dalhousie University, Centre for Global eHealth Innovation, University of Toronto, University of Saskatchewan, Alberta Children's Hospital, The Ottawa Hospital, Hamilton Health Sciences Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT02601755
Brief Title
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

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 1, 2017 (Actual)
Primary Completion Date
August 1, 2022 (Actual)
Study Completion Date
June 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hospital for Sick Children
Collaborators
Mount Sinai Hospital, Canada, IWK Health Centre, Nova Scotia Health Authority, Stollery Children's Hospital, University of Alberta, Dalhousie University, Centre for Global eHealth Innovation, University of Toronto, University of Saskatchewan, Alberta Children's Hospital, The Ottawa Hospital, Hamilton Health Sciences Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
302 (Actual)

8. Arms, Groups, and Interventions

Arm Title
iCanCope app and website
Arm Type
Experimental
Arm Description
Intervention: Behavioral: iCanCope app and website
Arm Title
Attention control group
Arm Type
Active Comparator
Arm Description
Intervention: Behavioral: Attention control group
Intervention Type
Behavioral
Intervention Name(s)
iCanCope app and website
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Attention control group
Intervention Description
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 Outcome Measure Information:
Title
Participant Accrual and Dropout Rates
Description
This will be centrally tracked by the clinical research project coordinator (CRPC).
Time Frame
8 weeks
Title
Intervention fidelity
Description
Any issues or difficulties encountered during implementation of the intervention, control strategy, or outcome measures will be tracked throughout the study by the CRPC.
Time Frame
8 weeks
Title
Acceptability and Satisfaction
Description
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.
Time Frame
8 weeks
Title
Engagement with Intervention
Description
Google Analytics will track patterns of app and website usage.
Time Frame
8 weeks
Title
Adherence
Description
Adherence will be determined using Google Analytics.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Pain intensity and interference
Description
Measured using the short form Brief Pain Inventory (BPI), a 15-item tool that measures pain intensity and impact on functioning.
Time Frame
8 weeks
Title
Self-efficacy
Description
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.
Time Frame
8 weeks
Title
Emotional Functioning
Description
Measured using the Hospital Anxiety and Depression Scale (HADS), a 14-item measure for the assessment of anxiety and depressive symptoms.
Time Frame
8 weeks
Title
Sleep Functioning
Description
Measured with the Insomnia Severity Index (ISI), a 7-item self-report questionnaire for assessing the nature, severity, and impact of insomnia.
Time Frame
8 weeks
Title
Social Functioning
Description
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.
Time Frame
8 weeks
Title
Health-Related Quality of Life
Description
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).
Time Frame
8 weeks
Title
Patients' Global Impression of Change
Description
Measured using the PGIC scale, a single item rating by participants of their perceived change during the trial.
Time Frame
8 weeks
Title
Pain-Related Knowledge
Description
Measured using a modified version of the Medical Issues, Exercise, Pain and Social Support (MEPS) questionnaire, a 27-item measure.
Time Frame
8 weeks
Title
Health Care Utilization
Description
Measured using the Chronic Pain Healthcare Utilization Form. (modified from the Ambulatory and Home Care Record)
Time Frame
8 weeks
Title
Adverse effects
Description
Will be tracked using the adverse event form.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Alberta Children's Hospital
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T3B 6A8
Country
Canada
Facility Name
Stollery Children's Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
Facility Name
University of Alberta
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2R7
Country
Canada
Facility Name
Nova Scotia Health Authority/Dalhousie University
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 2E1
Country
Canada
Facility Name
IWK Health Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3K 6R8
Country
Canada
Facility Name
Hamilton Health Sciences
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 3Z5
Country
Canada
Facility Name
The Ottawa Hospital
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
Mount Sinai Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X5
Country
Canada
Facility Name
Hospital for Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada
Facility Name
University of Saskatchewan
City
Saskatoon
State/Province
Saskatchewan
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
30664472
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.
Results Reference
derived

Learn more about this trial

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

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