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

Universiteit Antwerpen

Status: Enrolling

Conditions: Breast Cancer

Treatments: Behavioral: Face-to-face rehabilitation program; Behavioral: eHealth self-management support program

Study type: Interventional

Funder types: Other

Identifiers

NCT06308029

Edge003203

s68058 (Other Identifier)

T001122N (Other Grant/Funding Number)

Details and patient eligibility

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.

Full 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).

Enrollment: 270 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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270 participants in 3 patient groups

eHealth self-management support program

Experimental group

Description:

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.

Treatment:

Behavioral: eHealth self-management support program

Face-to-face rehabilitation program

Active Comparator group

Description:

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.

Treatment:

Behavioral: Face-to-face rehabilitation program

Usual care group

No Intervention group

Description:

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.