- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05319652
Feasibility Study of an Online Self-management Program for Chronic Non-cancer Pain
July 21, 2023 updated by: Anne-Marie-Pinard, CHU de Quebec-Universite Laval
Co-development and Assessment of the Feasibility and Potential Effects of an Online Self-management Program for Chronic Non-cancer Pain
Based on a mixed-methods design, the objective of this trial is to assess the feasibility and acceptability of the "Agir pour moi" program, an 8-week online self-management program for chronic non-cancer pain (CNCP).
The investigators will also explore its potential effects on self-efficacy, pain interference, pain severity, anxiety, depression, catastrophizing, and global impression of change in adults with CNCP awaiting services from a chronic pain multidisciplinary treatment center.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The mixed-methods sequential explanatory design combines a quantitative questionnaire-based study with a subsequent in depth qualitative approach.
Study Type
Interventional
Enrollment (Actual)
63
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Pascale Marier-Deschenes, MSc
- Phone Number: 4407 418-529-9141
- Email: pascale.marier-deschenes.1@ulaval.ca
Study Contact Backup
- Name: Anne Marie Pinard, MD, M(Ed.)
- Email: anne-marie.pinard@fmed.ulaval.ca
Study Locations
-
-
Quebec
-
Québec, Quebec, Canada, G1V 4G2
- CHU de Quebec
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Age ≥ 18 years;
- live with CNCP for more than 3 months;
- read and understand French easily;
- have access to a computer and high-speed Internet;
- be available to take part in the project for 6 to 8 months;
- not having started a new treatment for pain within the last month;
- agree to notify the team before starting a new treatment;
- be able to give informed consent.
Exclusion Criteria:
- be supported by a multidisciplinary treatment center or be likely to be in the short term;
- having participated in a CNCP self-management program within the last year;
- be awaiting scheduled surgical treatment within six months.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Pain self-management program
Participants log in to the online program and develop practical strategies to manage CNCP.
|
Each week for eight weeks, participants are invited to complete self-directed lessons on particular themes.
The program covers goal setting, stress management through relaxation, breathing and mindfulness, pacing, physical activity, thoughts and emotions, sleep, nutrition, flare-up management, and planning.
Through pain education, positive testimonials from individuals with CNCP applying the suggested strategies, reflective activities, goal setting and monitoring, and the gradual development of a personal plan, the program supports self-efficacy building to manage CNCP.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility of the recruitment
Time Frame: Baseline
|
|
Baseline
|
Feasibility of data collection
Time Frame: Baseline
|
|
Baseline
|
Feasibility of data collection
Time Frame: Post-intervention (8 weeks)
|
|
Post-intervention (8 weeks)
|
Feasibility of data collection
Time Frame: 3 months post-intervention
|
|
3 months post-intervention
|
Acceptability
Time Frame: Post-intervention (8 Weeks)
|
The Acceptability E-scale includes 6 items regarding how easy and enjoyable the program was to use, how understandable were the lessons, how helpful was completing the program, whether the participant liked the program, whether the amount of time to complete the program was acceptable, and overall satisfaction with the program.
Scores can range from 6 to 30.
Higher scores reprensent a high level of acceptability.
|
Post-intervention (8 Weeks)
|
Acceptability
Time Frame: 4 months post-intervention
|
Qualitative data from semi-structured interviews
|
4 months post-intervention
|
Adherence to the program
Time Frame: Post-intervention (8 weeks)
|
Completion rate of the program (completion is following ≥ 75% of the lessons)
|
Post-intervention (8 weeks)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in self-efficacy: French version of the Pain Self-Efficacy Questionnaire (PSEQ)
Time Frame: Baseline; Post-intervention (8 weeks); 3 months post-intervention
|
The PSEQ is a ten item questionnaire which assesses an individual's confidence in their ability to perform a variety of activities or tasks despite pain.
Scores can range from 0 to 60. Higher scores represent lower confidence to function with pain.
|
Baseline; Post-intervention (8 weeks); 3 months post-intervention
|
Change in pain severity and pain interference: French version of the Brief Pain Inventory (BPI)
Time Frame: Baseline; Post-intervention (8 weeks); 3 months post-intervention
|
The BPI includes a pain severity subscale and a pain interference subscale.
The pain interference subscale measures the extent to which pain interferes with functions such as general activity, walking ability, normal work, mood, relationships with people, enjoyment of life and sleep.
For each scale, the total score is the average of all items.
Scores can range from 0 to 10 for each subscale.
Higher scores indicate greater severity and more interference.
|
Baseline; Post-intervention (8 weeks); 3 months post-intervention
|
Change in anxiety and depression: French version of the Hospital Anxiety and Depression Scale (HADS)
Time Frame: Baseline; Post-intervention (8 weeks); 3 months post-intervention
|
The HADS is a 14-item scale.
Seven items relate to anxiety and seven relate to depression.
The anxiety and depression subscales each range from 0 to 21, with higher scores indicating higher anxiety/depression complains.
Patients were defined as having anxiety or depression or both if the score was 8 or more in the corresponding subscale.
|
Baseline; Post-intervention (8 weeks); 3 months post-intervention
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Change in pain catastrophizing: French version of the Pain Catastrophizing Scale (PCS)
Time Frame: Baseline; Post-intervention (8 weeks); 3 months post-intervention
|
The PCS is a 13-item questionnaire designed to assess catastrophic thinking in relation to pain.
It yields a total score and three subscale scores assessing rumination, magnification and helplessness.
Scores can range from 0 to 52.
Higher scores represent higher pain catastrophizing.
|
Baseline; Post-intervention (8 weeks); 3 months post-intervention
|
Patient Global Impression of Change Scale (PGIC)
Time Frame: Post-intervention (8 weeks); 3 months post-intervention
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The PGIC measures a patient's rating of overall improvement or lack thereof due to the intervention.
It is a 7 point scale depicting a patient's rating of overall improvement.
Patients rate their change as "very much improved," "much improved," "minimally improved," "no change," "minimally worse," "much worse," or "very much worse."
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Post-intervention (8 weeks); 3 months post-intervention
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Anne Marie Pinard, MD, M(Ed.), CHU de Quebec-Universite Laval
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 6, 2022
Primary Completion (Actual)
March 23, 2023
Study Completion (Actual)
March 23, 2023
Study Registration Dates
First Submitted
March 21, 2022
First Submitted That Met QC Criteria
April 4, 2022
First Posted (Actual)
April 8, 2022
Study Record Updates
Last Update Posted (Estimated)
July 24, 2023
Last Update Submitted That Met QC Criteria
July 21, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022-6312
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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