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

NCT05319652 | Completed

• 1 other identifier: 2022-6312
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (7)

• 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

• Feasibility of data collection

  * Rate of response to the questionnaires * Rate of completed questionnaires (no missing data)

  Baseline

• Feasibility of data collection

  * Rate of response to the questionnaires * Rate of completed questionnaires (no missing data)

  Post-intervention (8 weeks)

• Feasibility of data collection

  * Rate of response to the questionnaires * Rate of completed questionnaires (no missing data)

  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.

  Post-intervention (8 Weeks)

• Acceptability

  Qualitative data from semi-structured interviews

  4 months post-intervention

• Adherence to the program

  Completion rate of the program (completion is following ≥ 75% of the lessons)

  Post-intervention (8 weeks)

Secondary Outcomes (5)

• Change in self-efficacy: French version of the Pain Self-Efficacy Questionnaire (PSEQ)

  Baseline; Post-intervention (8 weeks); 3 months post-intervention

• Change in pain severity and pain interference: French version of the Brief Pain Inventory (BPI)

  Baseline; Post-intervention (8 weeks); 3 months post-intervention

• Change in anxiety and depression: French version of the Hospital Anxiety and Depression Scale (HADS)

  Baseline; Post-intervention (8 weeks); 3 months post-intervention

• Change in pain catastrophizing: French version of the Pain Catastrophizing Scale (PCS)

  Baseline; Post-intervention (8 weeks); 3 months post-intervention

• Patient Global Impression of Change Scale (PGIC)

  Post-intervention (8 weeks); 3 months post-intervention

Study Arms (1)

Pain self-management program

EXPERIMENTAL

Participants log in to the online program and develop practical strategies to manage CNCP.

Behavioral: Pain self-management program

Interventions

Pain self-management program BEHAVIORAL

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.

Pain self-management program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• CHU de Quebec-Universite Laval: lead

Study Sites (1)

CHU de Québec

Québec, Quebec, G1V 4G2, Canada

Location

Related Publications (1)

• 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.

  PMID: 38701440 DERIVED

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Anne Marie Pinard, MD, M(Ed.)

  CHU de Quebec-Universite Laval

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologist

Study Record Dates

• First Submitted: March 21, 2022
• First Posted: April 8, 2022
• Study Start: June 6, 2022
• Primary Completion: March 23, 2023
• Study Completion: March 23, 2023
• Last Updated: July 24, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)