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

Overview

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).

Interventions

• Behavioral 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. The eHealth program will be accessible from any
• Behavioral 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 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

Primary outcome measures

• Pain-related disability [Time frame: at 6 months follow-up]

Secondary outcome measures (12)

• Pain related disability [Time frame: at 12 weeks and 12 months follow-up]
• Pain severity [Time frame: at 12 weeks, 6 months and 12 months follow-up]
• Severity of neuropathic Pain [Time frame: at 12 weeks, 6 months and 12 months follow-up]
• Medication use [Time frame: at 12 weeks, 6 months and 12 months follow-up]
• Pain location [Time frame: at 12 weeks, 6 months and 12 months follow-up]
• Knowledge of neurophysiology of pain [Time frame: at 6 weeks]
• Physical Activity pattern [Time frame: at 12 weeks, 6 months and 12 months follow-up]
• Physical functioning [Time frame: at 12 weeks, 6 months and 12 months follow-up]
• Fatigue [Time frame: at 12 weeks, 6 months and 12 months follow-up]
• Sleep disturbance [Time frame: at 12 weeks, 6 months and 12 months follow-up]
• Pain Beliefs [Time frame: at 6 weeks, 12 weeks, 6 months and 12 months follow-up]
• Pain-related worrying [Time frame: at 12 weeks, 6 months and 12 months follow-up]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Belgium · 2 centers

• Universiteit Antwerpen — Antwerp
• KU Leuven — Leuven

Publications

• De Groef A, Dams L, Moseley GL, Heathcote LC, Wiles LK, Catley M, Vogelzang A, Hibbert P, Morlion B, Van Overbeke M, Tack E, Van Dijck S, Devoogdt N, Gursen C, De Paepe AL, Mertens M, van Olmen J, Willem L, Tjalma W, Nevelsteen I, Neven P, Vanhoudt R, Wildemeersch D, De Backere F, Fieuws S, Crombez G, Meeus M. Study protocol for a pragmatic randomised controlled trial in Belgian primary care and h PMID 40846340

Identifiers

NCT: NCT06308029 · Edge003203 · T001122N · s68058

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗