Clinical trial NCT06308029: Effectiveness of an eHealth Self-management Support Program for Persistent Pain After Breast Cancer Treatment
Official title: Effectiveness of an eHealth Self-management Support Program for Persistent Pain After Breast Cancer Treatment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Keywords: eHealth
pain
active lifestyle
pain management
physiotherapy
Lead sponsor: Universiteit Antwerpen
Sponsor class: OTHER
Collaborators: name: Universitaire Ziekenhuizen KU Leuven
name: University Ghent
name: KU Leuven
name: University Hospital, Antwerp
First posted: 2024-03-13
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pragmatic randomized, multi-centric, three-arm controlled trial
Primary purpose: TREATMENT

Brief 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.

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).

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

Primary outcomes:
measure: Pain-related disability
timeFrame: at 6 months follow-up
Secondary outcomes:
measure: Pain related disability
timeFrame: at 12 weeks and 12 months follow-up
measure: Pain severity
timeFrame: at 12 weeks, 6 months and 12 months follow-up
measure: Severity of neuropathic Pain
timeFrame: at 12 weeks, 6 months and 12 months follow-up
measure: Medication use
timeFrame: at 12 weeks, 6 months and 12 months follow-up
measure: Pain location
timeFrame: at 12 weeks, 6 months and 12 months follow-up
measure: Knowledge of neurophysiology of pain
timeFrame: at 6 weeks
measure: Physical Activity pattern
timeFrame: at 12 weeks, 6 months and 12 months follow-up
measure: Physical functioning
timeFrame: at 12 weeks, 6 months and 12 months follow-up
measure: Fatigue
timeFrame: at 12 weeks, 6 months and 12 months follow-up
measure: Sleep disturbance
timeFrame: at 12 weeks, 6 months and 12 months follow-up
measure: Pain Beliefs
timeFrame: at 6 weeks, 12 weeks, 6 months and 12 months follow-up
measure: Pain-related worrying
timeFrame: at 12 weeks, 6 months and 12 months follow-up
measure: Vigilance and interpretation of physical sensations
timeFrame: at 12 weeks, 6 months and 12 months follow-up
measure: Depression
timeFrame: at 12 weeks, 6 months and 12 months follow-up
measure: Anxiety
timeFrame: at 12 weeks, 6 months and 12 months follow-up
measure: Determinants for physical activity
timeFrame: at 12 weeks, 6 months and 12 months follow-up
measure: Participation
timeFrame: at 12 weeks, 6 months and 12 months follow-up
measure: Well-being
timeFrame: at 12 weeks, 6 months and 12 months follow-up
measure: Social Support
timeFrame: at 12 weeks, 6 months and 12 months follow-up
measure: Return to work rate
timeFrame: at 12 weeks, 6 months and 12 months follow-up
measure: Medical costs of medical consumption
timeFrame: at 12 weeks, 6 months and 12 months follow-up
measure: Indirect costs related to disease outside health care
timeFrame: at 12 weeks, 6 months and 12 months follow-up
measure: Health-related quality of life
timeFrame: at 12 weeks, 6 months and 12 months follow-up
measure: Patient Global Impression of Change
timeFrame: at 12 weeks follow-up
Other outcomes:
Locations:
city: Antwerpen
country: Belgium
facility: Universiteit Antwerpen
city: Leuven
country: Belgium
facility: KU Leuven
Study officials:
affiliation: Universiteit Antwerpen
name: An De Groef, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: KU Leuven
name: Nele Devoogdt, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: UGent
name: Geert Crombez, PhD
role: PRINCIPAL_INVESTIGATOR
References: