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

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ClinicalTrials.gov Identifier: NCT02601755
Recruitment Status : Recruiting
First Posted : November 10, 2015
Last Update Posted : July 19, 2018
Sponsor:
Collaborators:
Mount Sinai Hospital, Canada
IWK Health Centre
Nova Scotia Health Authority
Stollery Children's Hospital
University of Alberta
Information provided by (Responsible Party):
Jennifer Stinson, The Hospital for Sick Children

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.

Condition or disease Intervention/treatment Phase
Chronic Pain Behavioral: iCanCope app and website Behavioral: Attention control group Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: iCanCope With Pain: An Integrated Smartphone and Web Self-management Program for Adolescents and Young Adults With Chronic Pain
Actual Study Start Date : April 1, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

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.




Primary Outcome Measures :
  1. Participant Accrual and Dropout Rates [ Time Frame: 8 weeks ]
    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 Outcome Measures :
  1. Pain intensity and interference [ Time Frame: 8 weeks ]
    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: 8 weeks ]
    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: 8 weeks ]
    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: 8 weeks ]
    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: 8 weeks ]
    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: 8 weeks ]
    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: 8 weeks ]
    Measured using the PGIC scale, a single item rating by participants of their perceived change during the trial.

  8. Pain-Related Knowledge [ Time Frame: 8 weeks ]
    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: 8 weeks ]
    Measured using the Chronic Pain Healthcare Utilization Form. (modified from the Ambulatory and Home Care Record)

  10. Adverse effects [ Time Frame: 8 weeks ]
    Will be tracked using the adverse event form.



Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02601755


Contacts
Contact: Jennifer Stinson N Stinson, RN, PhD 416-813-7654 ext 304514 jennifer.stinson@sickkids.ca
Contact: Chitra Lalloo, PhD 416-813-7654 ext 302332 chitra.lalloo@sickkids.ca

Locations
Canada, Alberta
Stollery Children's Hospital Recruiting
Edmonton, Alberta, Canada, T6G 2B7
Contact: Michelle Verrier    780-407-8615    mrheault@ualberta.ca   
Principal Investigator: Mark Simmonds, MD         
University of Alberta Recruiting
Edmonton, Alberta, Canada, T6G 2R7
Contact: Michelle Verrier    780-407-8615    mrheault@ualberta.ca   
Principal Investigator: Saifee Rashiq, MD         
Principal Investigator: Bruce Dick, PhD         
Canada, Nova Scotia
Nova Scotia Health Authority/Dalhousie University Not yet recruiting
Halifax, Nova Scotia, Canada, B3H 2E1
Contact: Sara Whynot, MLT DHSA    902-473-5030    scwhynot@dal.ca   
Principal Investigator: Karim Mukhida, MD, PhD, FRCPC         
IWK Health Centre Not yet recruiting
Halifax, Nova Scotia, Canada, B3K 6R8
Contact: Sharon Amey, MDE    902-470-7703    Sharon.Amey@iwk.nshealth.ca   
Principal Investigator: Jill Chorney, PhD         
Canada, Ontario
Mount Sinai Hospital Not yet recruiting
Toronto, Ontario, Canada, M5G 1X5
Contact: Denise Paneduro, MA    416-586-4800 ext 2082    DPaneduro@mtsinai.on.ca   
Principal Investigator: Allan Gordon, MD, FRCPC         
Hospital for Sick Children Recruiting
Toronto, Ontario, Canada, M5G 1X8
Contact: Lauren Harris, OT (Reg)    416-813-7654 ext 302314    lauren.harris@sickkids.ca   
Contact: Chitra Lalloo, BHSc, PhD    416-813-7654 ext 202332    chitra.lalloo@sickkids.ca   
Principal Investigator: Jennifer Stinson, RN, PhD         
Sponsors and Collaborators
The Hospital for Sick Children
Mount Sinai Hospital, Canada
IWK Health Centre
Nova Scotia Health Authority
Stollery Children's Hospital
University of Alberta

Responsible Party: Jennifer Stinson, Clinician Scientist, Clinical Nurse Specialist/NP, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT02601755     History of Changes
Other Study ID Numbers: 1000047495
First Posted: November 10, 2015    Key Record Dates
Last Update Posted: July 19, 2018
Last Verified: July 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Chronic Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms