Effectiveness of an eHealth Self-management Support Program for Persistent Pain After Breast Cancer Treatment — PECAN  

Breast Cancer Clinical Trial

Official title: Effectiveness of an eHealth Self-management Support Program for Persistent Pain After Breast Cancer Treatment

Status Recruiting

Clinical Trial Summary

The scientific goals of the project are:

1. The primary scientific objective of the study is to determine the effectiveness of an eHealth self-management support program for persistent pain after breast cancer treatment compared to:

• usual care (i.e. superiority of the eHealth self-management support program) and

• a comprehensive pain rehabilitation program delivered face-to-face in a physical therapy setting (i.e. non-inferiority of the eHealth self-management support program)

on pain-related disability (measured with the Pain Disability Index).

2. The secondary scientific objectives of this study entails to examine if the eHealth self-management support program has a relative benefit for other biopsychosocial factors, including:

• Other dimensions of pain

• Health-related quality of life

• Physical functioning, including physical activity levels

• Psychosocial functioning, including self-efficacy, stress, anxiety, depression, coping style (key secondary outcome) and fear of cancer recurrence

• Participation in society, including return to work

• Healthcare-related costs for the patient and society

3. The tertiary scientific objectives of this study are

• to identify moderators of treatment effect, including behavioural determinants (e.g. self-efficacy, motivation, coping style), in order to identify breast cancer survivors who would benefit the most of the eHealth self-management support program and to allow more stratified and efficient pain management care and more targeted allocation of budgets.

• To examine the implementation process, mechanisms of impact and contextual factors.

Clinical Trial Description

The current state-of-the art advocates for a biopsychosocial rehabilitation approach for persistent pain after breast cancer treatment. Within this approach pain science education is combined with promotion of an active lifestyle based on self-regulation techniques. The investigators argue for testing an innovative eHealth self-management support program for this purpose. The assumption is that this delivery mode reduces barriers to pain self-management support, by bringing timely support near to people, creating a safe environment as opposed to hospital settings, providing a multidimensional support model taking into account the biopsychosocial needs of patients, and lowering costs. This program can provide patients with the knowledge, proactive, cognitive and self-management skills to master their situation and journey towards less pain and pain-related disability and participation in normal life again. Therefore, the general aim of the proposed project is to investigate the effectiveness of an eHealth self-management support program for pain-related disability (I) in breast cancer survivors with persistent pain (P). The program makes use of an innovative chatbot format for delivering pain science education and motivating and monitoring physical activity. The eHealth program is automated using comprehensive decision-tree-based algorithms in order to promote pain self-management support. The primary scientific objective of the study is to determine the effectiveness of this eHealth self-management support program for persistent pain after breast cancer treatment compared to 1) usual care (i.e. superiority of the eHealth self-management support program) (C1) and 2) a comprehensive pain rehabilitation program delivered face-to-face in a physical therapy setting (i.e. non-inferiority of the eHealth self-management support program) (C2) on pain-related disability (O). ;

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

• NCT number: NCT06308029
• Study type: Interventional
• Source: Universiteit Antwerpen
• Contact: An De Groef, PhD
• Phone: 003216342171
• Email: an.degroef@uantwerpen.be
• Status: Recruiting
• Phase: N/A
• Start date: April 12, 2024
• Completion date: March 20, 2028