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ClinicalTrials.gov ID

NCT06308029

Lead Sponsor

Universiteit AntwerpenOTHER

Overall Status

Recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

270Estimated

Last Update Posted

Jun 26, 2025Actual

Start Date

May 26, 2024Actual

Primary Completion Date

Jun 2028Estimated

Completion Date

Jan 2029Estimated

Official Title

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

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 (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.

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 (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).

• Breast Cancer

• eHealth self-management support program
• Face-to-face rehabilitation program

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion criteria

• Patients (men and women) with primary breast cancer and with unilateral or bilateral axillary surgery (Axillary Lymph Node Dissection or Sentinel Node Biopsy);
• Be non-metastatic and have finished their primary treatment with a curative intent at least 3 months prior to study participation;
• Adjuvant hormonal therapy and immunotherapy form the exception to the rule are tolerated;
• Presence of self-reported persistent pain in the last 3 months that interferes with daily activities (yes/no)

Exclusion criteria

• Can not participate during the entire study period;
• Mentally or physically unable to participate in the study;
• Previous participation in a pain science education program.
• No acces to a digital device
• Do not speak/understand Dutch

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

Universiteit AntwerpenOTHER

Collaborators

Universitaire Ziekenhuizen KU LeuvenOTHER

University GhentOTHER

KU LeuvenOTHER

University Hospital, AntwerpOTHER

nele.devoogdt@kuleuven.be