Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Symptoms and General Pathology

Breast Neoplasms

Pain

Breast Diseases

Skin Diseases

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 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.

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.

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.

eHealth self-management support 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 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.

Face-to-face rehabilitation program

An De Groef, PhD

Lore Dams, PhD

Nele Devoogdt, PhD

Geert Crombez, PhD

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.

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).

Pragmatic randomized, multi-centric, three-arm controlled trial

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

The data are not openly available and are available from the principal investigator upon reasonable request.

Measured with Pain Disability Index, an instrument for measuring the impact that pain has on the ability of a person to participate in essential life activities. Scores between 0 and 70. The higher the score the greater the person's disability due to pain. The trial will be termed successful when superiority of the eHealth self-management to usual care and non-inferiority of the eHealth self-management program to face-to face rehabilitation program has been shown for the primary outcome at 6 months. Both tests will be based on the comparison of the mean value after correction for the baseline PDI (ANCOVA approach).

Measured with Pain Disability Index, an instrument for measuring the impact that pain has on the ability of a person to participate in essential life activities. Scores between 0 and 70. The higher the score the greater the person's disability due to pain

Measured with a Visual Analogue Scale (0-100), a higher score indicates more severe pain.

Measured with the Neuropathic Pain Symptom Inventory (0-100), a higher score indicates more severe pain.

measured with the Neurophysiology of Pain Test

measured with the Patterns of Activity Measure - Pain (short form). It measures 3 pain-related activity patterns: avoidance, overdoing, and pacing. Potential scores on each of the 3 POAM-P scales can range from 0 to 20. Higher scores in any pattern indicate more of the measured construct.

measured with the Patient-Reported Outcomes Measurement Information System (PROMIS)-57 Profile v2.01. Each domain of the PROMIS-57 is expressed as a score compared to the average of a group (T-score). A T-score is a standardized score. The average score in a population is assigned the value 50. The standard deviation becomes equated to 10 points.

measured with the Patient-Reported Outcomes Measurement Information System( PROMIS)-57 Profile v2.01. Each domain of the PROMIS-57 is expressed as a score compared to the average of a group (T-score). A T-score is a standardized score. The average score in a population is assigned the value 50. The standard deviation becomes equated to 10 points.

Measured with the Survey of Pain Attitudes (SOPA)-short form. It contains seven subscales including 30 items in total with a 5-item Likert scale. Each domain of the SOPA is expressed as a score compared to the average of a group (T-score).

Measured with the Pain Catastrophizing Scale. Thirteen items are scored on a 5-item Likert scale ranging from "not" to "always". The total score ranges from 0 to 52, where higher scores are associated with higher levels of catastrophizing.

Measured with the Bodily Threat Monitoring Scale. This is a new 19-item self-report measure that captures the tendency to monitor and interpret bodily sensations as symptomatic of something being wrong with one's body. Scores range from 0 to 76, with higher scores indicating greater bodily threat monitoring.

measured with the Patient-Reported Outcomes Measurement Information System (PROMIS)-57 Profile v2.01.Each domain of the PROMIS-57 is expressed as a score compared to the average of a group (T-score). A T-score is a standardized score. The average score in a population is assigned the value 50. The standard deviation becomes equated to 10 points.

measured with the Determinants of Physical Activity Questionnaire. Each item was assessed using a 7-point scale for all determinants of physical activity. Lower scores indicate low exercisers, while high scores indicate high exercisers.

measured with the PROMIS-57 Profile v2.01. Each domain of the PROMIS-57 is expressed as a score compared to the average of a group (T-score). A T-score is a standardized score. The average score in a population is assigned the value 50. The standard deviation becomes equated to 10 points.

measured with the Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health. Each domain of the PROMIS is expressed as a score compared to the average of a group (T-score). A T-score is a standardized score. The average score in a population is assigned the value 50. The standard deviation becomes equated to 10 points.

measured with a self-composed questionnaire

measured with the Medical Consumption Questionnaire. The costs of medical consumption are calculated by measuring the volumes of care multiplied by the cost price per unit of care.

measured with the Productivity Cost Questionnaire. To calculate the costs of production losses, volumes are multiplied with unit costs.

measured with the EuroQol-5Dimensions-5Levels (EQ-5D-5L) questionnaire. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. Standard EQ-5D-5L value sets are available for different regions. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale where the endpoints are labelled 'The best health you can image' and 'The worst health you can image'. The VAS can be used as a quantitative measure of health outcome that reflects the patient's own judgement.

measured with the Patient Global Impression of Change (PGIC). PGIC is a 7 point scale depicting a patient's rating of overall improvement. Patients rate their change as "very much improved," "much improved," "minimally improved," "no change," "minimally worse," "much worse," or "very much worse."

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Effectiveness of an eHealth Self-management Support Program for Persistent Pain After Breast Cancer Treatment	NCT06308029	Breast Cancer	eHealth self-ma... Face-to-face re...	18 Years -	Universiteit Antwerpen
Effectiveness of an eHealth Self-management Support Program for Persistent Pain After Breast Cancer Treatment	NCT06308029	Breast Cancer	eHealth self-ma... Face-to-face re...	18 Years -	Universiteit Antwerpen
Effectiveness of an eHealth Self-management Support Program for Persistent Pain After Breast Cancer Treatment	NCT06308029	Breast Cancer	eHealth self-ma... Face-to-face re...	18 Years -	Universiteit Antwerpen

Spots Global Cancer Trial Database for active lifestyle