Back to resultsFeasibility Study of an Online Self-management Program for Chronic Non-cancer Pain
Primary Purpose
Chronic Pain
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Pain self-management program
Sponsored by
About this trial
This is an interventional other trial for Chronic Pain
Eligibility Criteria
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.
Sites / Locations
- CHU de Québec
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Pain self-management program
Arm Description
Participants log in to the online program and develop practical strategies to manage CNCP.
Outcomes
Primary Outcome Measures
Feasibility of the recruitment
Number of potentially eligible adults referred by the multidisciplinary treatment center over the recruitment period
Number of referred adults who respond to the invitation
Number of referred adults who consent to participate in the study
Number of interested adults excluded based on inclusion/exclusion criteria
Feasibility of data collection
Rate of response to the questionnaires
Rate of completed questionnaires (no missing data)
Feasibility of data collection
Rate of response to the questionnaires
Rate of completed questionnaires (no missing data)
Feasibility of data collection
Rate of response to the questionnaires
Rate of completed questionnaires (no missing data)
Acceptability
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.
Acceptability
Qualitative data from semi-structured interviews
Adherence to the program
Completion rate of the program (completion is following ≥ 75% of the lessons)
Secondary Outcome Measures
Change in self-efficacy: French version of the Pain Self-Efficacy Questionnaire (PSEQ)
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.
Change in pain severity and pain interference: French version of the Brief Pain Inventory (BPI)
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.
Change in anxiety and depression: French version of the Hospital Anxiety and Depression Scale (HADS)
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.
Change in pain catastrophizing: French version of the Pain Catastrophizing Scale (PCS)
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.
Patient Global Impression of Change Scale (PGIC)
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."
Full Information
NCT ID
NCT05319652
First Posted
March 21, 2022
Last Updated
July 21, 2023
Sponsor
CHU de Quebec-Universite Laval
1. Study Identification
Unique Protocol Identification Number
NCT05319652
Brief Title
Feasibility Study of an Online Self-management Program for Chronic Non-cancer Pain
Official Title
Co-development and Assessment of the Feasibility and Potential Effects of an Online Self-management Program for Chronic Non-cancer Pain
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
June 6, 2022 (Actual)
Primary Completion Date
March 23, 2023 (Actual)
Study Completion Date
March 23, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
CHU de Quebec-Universite Laval
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
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.
Detailed Description
The mixed-methods sequential explanatory design combines a quantitative questionnaire-based study with a subsequent in depth qualitative approach.
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
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
63 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pain self-management program
Arm Type
Experimental
Arm Description
Participants log in to the online program and develop practical strategies to manage CNCP.
Intervention Type
Behavioral
Intervention Name(s)
Pain self-management program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility of the recruitment
Description
Number of potentially eligible adults referred by the multidisciplinary treatment center over the recruitment period
Number of referred adults who respond to the invitation
Number of referred adults who consent to participate in the study
Number of interested adults excluded based on inclusion/exclusion criteria
Time Frame
Baseline
Title
Feasibility of data collection
Description
Rate of response to the questionnaires
Rate of completed questionnaires (no missing data)
Time Frame
Baseline
Title
Feasibility of data collection
Description
Rate of response to the questionnaires
Rate of completed questionnaires (no missing data)
Time Frame
Post-intervention (8 weeks)
Title
Feasibility of data collection
Description
Rate of response to the questionnaires
Rate of completed questionnaires (no missing data)
Time Frame
3 months post-intervention
Title
Acceptability
Description
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.
Time Frame
Post-intervention (8 Weeks)
Title
Acceptability
Description
Qualitative data from semi-structured interviews
Time Frame
4 months post-intervention
Title
Adherence to the program
Description
Completion rate of the program (completion is following ≥ 75% of the lessons)
Time Frame
Post-intervention (8 weeks)
Secondary Outcome Measure Information:
Title
Change in self-efficacy: French version of the Pain Self-Efficacy Questionnaire (PSEQ)
Description
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.
Time Frame
Baseline; Post-intervention (8 weeks); 3 months post-intervention
Title
Change in pain severity and pain interference: French version of the Brief Pain Inventory (BPI)
Description
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.
Time Frame
Baseline; Post-intervention (8 weeks); 3 months post-intervention
Title
Change in anxiety and depression: French version of the Hospital Anxiety and Depression Scale (HADS)
Description
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.
Time Frame
Baseline; Post-intervention (8 weeks); 3 months post-intervention
Title
Change in pain catastrophizing: French version of the Pain Catastrophizing Scale (PCS)
Description
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.
Time Frame
Baseline; Post-intervention (8 weeks); 3 months post-intervention
Title
Patient Global Impression of Change Scale (PGIC)
Description
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."
Time Frame
Post-intervention (8 weeks); 3 months post-intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne Marie Pinard, MD, M(Ed.)
Organizational Affiliation
CHU de Quebec-Universite Laval
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Québec
City
Québec
State/Province
Quebec
ZIP/Postal Code
G1V 4G2
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
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Feasibility Study of an Online Self-management Program for Chronic Non-cancer Pain
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