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

NCT ID: NCT02601755

Last Updated: 2023-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

302 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-01

Study Completion Date

2023-08-01

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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iCanCope app and website

Intervention: Behavioral: iCanCope app and website

Group Type EXPERIMENTAL

iCanCope app and website

Intervention Type 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

Intervention: Behavioral: Attention control group

Group Type ACTIVE_COMPARATOR

Attention control group

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mount Sinai Hospital, Canada

OTHER

Sponsor Role collaborator

IWK Health Centre

OTHER

Sponsor Role collaborator

Nova Scotia Health Authority

OTHER

Sponsor Role collaborator

Stollery Children's Hospital

OTHER

Sponsor Role collaborator

University of Alberta

OTHER

Sponsor Role collaborator

Dalhousie University

OTHER

Sponsor Role collaborator

Centre for Global eHealth Innovation

OTHER

Sponsor Role collaborator

University of Toronto

OTHER

Sponsor Role collaborator

University of Saskatchewan

OTHER

Sponsor Role collaborator

Alberta Children's Hospital

OTHER

Sponsor Role collaborator

The Ottawa Hospital

OTHER

Sponsor Role collaborator

Hamilton Health Sciences Corporation

OTHER

Sponsor Role collaborator

The Hospital for Sick Children

OTHER

Sponsor Role lead

Responsible Party

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Jennifer Stinson

Clinician Scientist, Clinical Nurse Specialist/NP

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Alberta Children's Hospital

Calgary, Alberta, Canada

Site Status

Stollery Children's Hospital

Edmonton, Alberta, Canada

Site Status

University of Alberta

Edmonton, Alberta, Canada

Site Status

Nova Scotia Health Authority/Dalhousie University

Halifax, Nova Scotia, Canada

Site Status

IWK Health Centre

Halifax, Nova Scotia, Canada

Site Status

Hamilton Health Sciences

Hamilton, Ontario, Canada

Site Status

The Ottawa Hospital

Ottawa, Ontario, Canada

Site Status

Mount Sinai Hospital

Toronto, Ontario, Canada

Site Status

Hospital for Sick Children

Toronto, Ontario, Canada

Site Status

University of Saskatchewan

Saskatoon, Saskatchewan, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type DERIVED
PMID: 30664472 (View on PubMed)

Other Identifiers

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1000047495

Identifier Type: -

Identifier Source: org_study_id