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Trial Title:
Effectiveness of an eHealth Self-management Support Program for Persistent Pain After Breast Cancer Treatment
NCT ID:
NCT06308029
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
eHealth
pain
active lifestyle
pain management
physiotherapy
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Pragmatic randomized, multi-centric, three-arm controlled trial
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
eHealth self-management support program
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. The eHealth program will be accessible from any digital device (laptop,
tablet, smartphone) after receiving a personal login code provided by the researcher.
Participants go through the eHealth program independently at their own pace. It is
recommended to do this in 8-12 weeks.
Arm group label:
eHealth self-management support program
Intervention type:
Behavioral
Intervention name:
Face-to-face rehabilitation program
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 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 and written. 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. It is recommend to organise the in total 9 face-to-face
sessions within a periode of 8-12 weeks.
Arm group label:
Face-to-face rehabilitation program
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).
Criteria for 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 in complete remission and should 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Universiteit Antwerpen
Address:
City:
Antwerpen
Country:
Belgium
Status:
Recruiting
Contact:
Last name:
An De Groef, PhD
Email:
an.degroef@uantwerpen.be
Contact backup:
Last name:
Lore Dams, PhD
Email:
lore.dams@uantwerpen.be
Facility:
Name:
KU Leuven
Address:
City:
Leuven
Country:
Belgium
Status:
Recruiting
Contact:
Last name:
Nele Devoogdt, PhD
Email:
nele.devoogdt@kuleuven.be
Contact backup:
Last name:
An De Groef, PhD
Email:
an.degroef@kuleuven.be
Start date:
April 12, 2024
Completion date:
March 20, 2028
Lead sponsor:
Agency:
Universiteit Antwerpen
Agency class:
Other
Collaborator:
Agency:
Universitaire Ziekenhuizen KU Leuven
Agency class:
Other
Collaborator:
Agency:
University Ghent
Agency class:
Other
Collaborator:
Agency:
KU Leuven
Agency class:
Other
Collaborator:
Agency:
University Hospital, Antwerp
Agency class:
Other
Source:
Universiteit Antwerpen
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06308029
