Chronic PainNCT05319652
Feasibility Study of an Online Self-management Program for Chronic Non-cancer Pain
A study testing Pain self-management program in people with Chronic Pain, run by CHU de Quebec-Universite Laval at 1 site in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Pain self-management program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteCanada
- Study dates
- 6 Jun 2022to 23 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
The mixed-methods sequential explanatory design combines a quantitative questionnaire-based study with a subsequent in depth qualitative approach.
- Conditions
- Chronic Pain
- Being tested
- Pain self-management program
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain self-management programBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Pain self-management program | Experimental | Participants log in to the online program and develop practical strategies to manage CNCP. Receives: Behavioral: Pain self-management program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline
Feasibility of data collection
- Rate of response to the questionnaires
- Rate of completed questionnaires (no missing data)
Measured: Baseline
Feasibility of data collection
- Rate of response to the questionnaires
- Rate of completed questionnaires (no missing data)
Measured: Post-intervention (8 weeks)
Feasibility of data collection
- Rate of response to the questionnaires
- Rate of completed questionnaires (no missing data)
Measured: 3 months post-intervention
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.
Measured: Post-intervention (8 Weeks)
Acceptability
Qualitative data from semi-structured interviews
Measured: 4 months post-intervention
Adherence to the program
Completion rate of the program (completion is following ≥ 75% of the lessons)
Measured: Post-intervention (8 weeks)
Secondary outcomes (5)
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.
Measured: Baseline; Post-intervention (8 weeks); 3 months post-intervention
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.
Measured: Baseline; Post-intervention (8 weeks); 3 months post-intervention
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.
Measured: Baseline; Post-intervention (8 weeks); 3 months post-intervention
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.
Measured: Baseline; Post-intervention (8 weeks); 3 months post-intervention
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."
Measured: Post-intervention (8 weeks); 3 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2022
- Study start6 Jun 2022
- Primary completion23 Mar 2023
- Study completion23 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHU de Quebec-Universite Laval
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anne-Marie-Pinard, CHU de Quebec-Universite Laval
- Investigators
- Anne Marie Pinard, MD, M(Ed.), Principal investigator, CHU de Quebec-Universite Laval
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05319652
- Sponsor's protocol ID
- 2022-6312
- Status last verified
- Jul 2023
- First submitted
- 21 Mar 2022
- Last updated
- 24 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Marier-Deschenes P, Pinard AM, Jalbert L, LeBlanc A. Assessing the Feasibility and Preliminary Effects of a Web-Based Self-Management Program for Chronic Noncancer Pain: Mixed Methods Study. JMIR Hum Factors. 2024 May 3;11:e50747. doi: 10.2196/50747.
PubMed 38701440
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Co-development and Assessment of the Feasibility and Potential Effects of an Online Self-management Program for Chronic Non-cancer Pain
- ClinicalTrials.gov ID
- NCT05319652
- Acronym / sponsor ID
- 2022-6312
- Conditions
- Chronic Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- CHU de Quebec-Universite LavalUniversity, hospital or other
- Study start
- 6 Jun 2022 (actual)
- Primary completion
- 23 Mar 2023 (actual)
- Study completion
- 23 Mar 2023 (actual)
- First posted
- 8 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pain self-management program | Experimental | Behavioral: Pain self-management programParticipants log in to the online program and develop practical strategies to manage CNCP. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pain self-management programEach 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. | Behavioural | Pain self-management program |
Primary outcome
Feasibility of the recruitment
Time frame: Baseline
* 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
Time frame: Baseline
* Rate of response to the questionnaires * Rate of completed questionnaires (no missing data)
Feasibility of data collection
Time frame: Post-intervention (8 weeks)
* Rate of response to the questionnaires * Rate of completed questionnaires (no missing data)
Feasibility of data collection
Time frame: 3 months post-intervention
* Rate of response to the questionnaires * Rate of completed questionnaires (no missing data)
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.
Acceptability
Time frame: 4 months post-intervention
Qualitative data from semi-structured interviews
Adherence to the program
Time frame: Post-intervention (8 weeks)
Completion rate of the program (completion is following ≥ 75% of the lessons)
5 secondary outcomes
Change in self-efficacy: French version of the Pain Self-Efficacy Questionnaire (PSEQ)
Time frame: 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
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
Change in pain catastrophizing: French version of the Pain Catastrophizing Scale (PCS)
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2023.
- Derived from this study: PubMed 38701440Marier-Deschenes P, Pinard AM, Jalbert L, LeBlanc A. Assessing the Feasibility and Preliminary Effects of a Web-Based Self-Management Program for Chronic Noncancer Pain: Mixed Methods Study. JMIR Hum Factors. 2024 May 3;11:e50747. doi: 10.2196/50747.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne Marie Pinard, MD, M(Ed.) principal investigator
CHU de Quebec-Universite Laval
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pain self-management program in people with Chronic Pain, run by CHU de Quebec-Universite Laval at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of the recruitment (time frame: Baseline). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05319652, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2023.