Feasibility Study of an Online Self-management Program for Chronic Non-cancer Pain

Chronic Pain Clinical Trial

Official title:

Co-development and Assessment of the Feasibility and Potential Effects of an Online Self-management Program for Chronic Non-cancer Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05319652
• Other study ID #: 2022-6312
• Status: Completed
• Phase: N/A
• Start date: June 6, 2022
• Est. completion date: March 23, 2023

Study information

• Verified date: July 2023
• Source: CHU de Quebec-Universite Laval
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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.

Description:

The mixed-methods sequential explanatory design combines a quantitative questionnaire-based study with a subsequent in depth qualitative approach.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: March 23, 2023
• Est. primary completion date: March 23, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Behavioral:
• Pain self-management program
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.

Locations

Country	Name	City	State
Canada	CHU de Québec	Québec	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
CHU de Quebec-Universite Laval

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Baseline
Primary	Feasibility of data collection	Rate of response to the questionnaires; Rate of completed questionnaires (no missing data)	Baseline
Primary	Feasibility of data collection	Rate of response to the questionnaires; Rate of completed questionnaires (no missing data)	Post-intervention (8 weeks)
Primary	Feasibility of data collection	Rate of response to the questionnaires; Rate of completed questionnaires (no missing data)	3 months post-intervention
Primary	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.	Post-intervention (8 Weeks)
Primary	Acceptability	Qualitative data from semi-structured interviews	4 months post-intervention
Primary	Adherence to the program	Completion rate of the program (completion is following = 75% of the lessons)	Post-intervention (8 weeks)
Secondary	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.	Baseline; Post-intervention (8 weeks); 3 months post-intervention
Secondary	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.	Baseline; Post-intervention (8 weeks); 3 months post-intervention
Secondary	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.	Baseline; Post-intervention (8 weeks); 3 months post-intervention
Secondary	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.	Baseline; Post-intervention (8 weeks); 3 months post-intervention
Secondary	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."	Post-intervention (8 weeks); 3 months post-intervention