Ignite Creation Date:
2024-05-06 @ 8:14 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06308029
Status:
RECRUITING
Last Update Posted:
2024-04-15
First Post:
2024-03-06
Brief Title:
Effectiveness of an eHealth Self-management Support Program for Persistent Pain After Breast Cancer Treatment
Sponsor:
Universiteit Antwerpen
Organization:
Universiteit Antwerpen
Study Overview
Official Title:
Effectiveness of an eHealth Self-management Support Program for Persistent Pain After Breast Cancer Treatment
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PECAN
Brief 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 ie superiority of the eHealth self-management support program and
a comprehensive pain rehabilitation program delivered face-to-face in a physical therapy setting ie 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 eg 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
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 ie superiority of the eHealth self-management support program and
a comprehensive pain rehabilitation program delivered face-to-face in a physical therapy setting ie 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 eg 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
Detailed 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 ie 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 ie non-inferiority of the eHealth self-management support program C2 on pain-related disability O
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| s68058 | OTHER | UZKU Leuven ID | None |
| T001122N | OTHER_GRANT | None | None |