Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06308029

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

Led by Universiteit Antwerpen · Updated on 2025-06-26

270

Participants Needed

2

Research Sites

240 weeks

Total Duration

On this page

Sponsors

U

Universiteit Antwerpen

Lead Sponsor

U

Universitaire Ziekenhuizen KU Leuven

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients (men and women) with primary breast cancer and with unilateral or bilateral axillary surgery (Axillary Lymph Node Dissection or Sentinel Node Biopsy)
  • Non-metastatic breast cancer and finished primary treatment with curative intent at least 3 months prior to participation
  • Adjuvant hormonal therapy and immunotherapy are allowed
  • Presence of self-reported persistent pain in the last 3 months that interferes with daily activities
Not Eligible

You will not qualify if you...

  • Unable to participate for the entire study period
  • Mentally or physically unable to participate in the study
  • Previous participation in a pain science education program
  • No access to a digital device
  • Do not speak or understand Dutch

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Universiteit Antwerpen

Antwerp, Belgium

Actively Recruiting

2

KU Leuven

Leuven, Belgium

Actively Recruiting

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Research Team

A

An De Groef, PhD

CONTACT

L

Lore Dams, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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