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

ConditionBreast Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversiteit Antwerpen

About this trial

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.

Eligibility criteria

Qualifiers

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)

Disqualifiers

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

Trial design

Treatments tested in this trial

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

Treatment groups

270 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Universiteit Antwerpen

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Collaborator

University Ghent

Collaborator

KU Leuven

Collaborator

University Hospital, Antwerp

Collaborator