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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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)

Locations
Other Locations
Belgium
Universiteit Antwerpen
RECRUITING
Antwerp
KU Leuven
RECRUITING
Leuven
Contact Information
Primary
An De Groef, PhD
an.degroef@uantwerpen.be
003216342171
Backup
Lore Dams, PhD
lore.dams@uantwerpen.be
Time Frame
Start Date: 2024-05-26
Estimated Completion Date: 2029-01
Participants
Target number of participants: 270
Treatments
Experimental: eHealth self-management support program
This web-based eHealth program consists of two parts. First participants will complete a pain science education program. After being primed in the educational program, barriers for a physically active lifestyle should be removed and participants should be able to apply the learned information in the second part. The second part of the self-management support program consists of daily activity planning and strategies to promote an active lifestyle.
Active_comparator: Face-to-face rehabilitation program
The face-to-face rehabilitation program combines pain science education with an active behavioral approach. First, 2-3 individual face-to-face sessions are organized with a physical therapist (recruited and trained by the research team) to provide pain science education. The content of this pain science education program is the same as for the eHealth program. Similar as in the eHealth program, this education intervention includes advice for activity management, while experiencing pain and other symptoms, in order to remove barriers for an active lifestyle. The educational information will be presented verbally (explanation by the therapist) and written (information leaflet, summaries, pictures, metaphors and diagrams on computer and paper). After the education, the physical therapist will discuss proper goal setting with the patient to reach an active lifestyle and will coach the participant to reach these goals with maximum 6 face-to-face sessions.
No_intervention: Usual care group
Usual care for breast cancer survivors with persistent pain consists of primarily a pharmacological approach and general advice to stay or become active. This information is given to the participant by means of a brochure.
Related Therapeutic Areas
Sponsors
Collaborators: University Ghent, Universitaire Ziekenhuizen KU Leuven, University Hospital, Antwerp, KU Leuven
Leads: Universiteit Antwerpen

This content was sourced from clinicaltrials.gov