Effectiveness of a Modern Educational Intervention in Breast Cancer Patients

Study Overview
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Brief Summary
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In addition to fatigue, pain is the most frequent and persistent symptom following breast cancer and breast cancer treatment. Despite the effectiveness of different physical therapy modalities, such as manual techniques, passive mobilizations and exercises, many patients still experience pain and subsequent difficulties in daily functioning at short and long term. Past decades, the awareness on the important role of educational interventions in the management of pain in general has increased. Educational interventions aim at explaining and improving the knowledge, control and attitude of the patient regarding his/her pain complaint. However, these educational interventions are often restricted to more biomedical pain management instructions and general advice on physical activity and analgesics (= traditional biomedical education). Only recently, increased knowledge on pain mechanisms led to a more modern educational approach. This modern approach is suited to explain more complex issues associated with pain and takes into account many more factors related to pain. To our knowledge, only one controlled trial investigated the effectiveness of a modern educational intervention in the early stage of breast cancer treatment. The results were very promising for shoulder function. However, only short-term effects were examined, no randomization was performed and no pain-related and socio-economic outcomes were evaluated. Therefore, the aim of the proposed project is to investigate the effectiveness of a similar modern educational program, in addition to standard physical therapy care, in the early treatment phase of breast cancer in comparison with traditional biomedical education. A randomized controlled trial will be performed with a long-term follow up period. The primary outcome parameter is pain-related disability. Secondary outcomes are different dimensions of pain, physical and mental functioning, return to work and health-care related costs.

Official Title
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The Effectiveness of a Modern Educational Intervention for Pain-related Disability After Breast Cancer Surgery: Randomized Controlled Trial

Conditions
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Pain, Breast Neoplasm

Intervention / Treatment
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* Other: Standard physical therapy program
* Other: Modern educational program
* Other: Traditional biomedical educational program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with primary breast cancer Unilateral surgery including, either: Axillary lymph node dissection and mastectomy/breast -conserving/reconstructive surgery OR Sentinel Node Biopsy and mastectomy/reconstructive surgery Exclusion Criteria: Active metastasis Cannot participate during the entire study period
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Standard physical therapy program + Modern educational program | Other: Standard physical therapy program<br>* Mobilisations, stretching, scar tissue treatment and exercises Start immediately after surgery, sessions are individual and take 30 minutes Intensive phase (4 months): 1-2x/week Maintenance phase (8 months, 3 sessions): 6, 8 and 12 months post-surgery<br>Other: Modern educational program<br>* This modern neuroscience educational approach is suited to explain more complex issues associated with pain such as the involvement of peripheral and central mechanisms, neuroplasticity and pain behaviour. Sessions are individual and take 30 minutes, in addition to the standard physical therapy sessions 3 sessions during week 1-2, 3 booster sessions at 6, 8 and 12 months post-surgery<br>|
| Active Comparator: Control group<br>Standard physical therapy program + Traditional biomedical educational program | Other: Standard physical therapy program<br>* Mobilisations, stretching, scar tissue treatment and exercises Start immediately after surgery, sessions are individual and take 30 minutes Intensive phase (4 months): 1-2x/week Maintenance phase (8 months, 3 sessions): 6, 8 and 12 months post-surgery<br>Other: Traditional biomedical educational program<br>* Traditional educational interventions are applied according to the biomedical model. This means that the patient's pain experience is explained from a tissue (injured versus healthy tissue) and biomechanics perspective Sessions are individual and take 30 minutes, in addition to the standard physical therapy sessions 3 sessions during week 1-2, 3 booster sessions at 6, 8 and 12 months post-surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-reported change in pain-related disability | 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. | Change between baseline and one year follow-up assessment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-reported pain-related disability | Measured with Pain Disability Index | Postoperatively after 4 months of intensive treatment and at 1,5 years (after follow-up) | 
| Self-reported pain-intensity | Measured with Visual Analogue Scale | Postoperatively after 4 months of intensive treatment, at 1 year (after maintenance treatment) and at 1,5 years (after follow-up) | 
| Self-reported pain severity | Measured with the Brief Pain Inventory | Postoperatively after 4 months of intensive treatment, at 1 year (after maintenance treatment) and at 1,5 years (after follow-up) | 
| Prevalence of neuropathic pain | Measured with the Douleur Neuropathique en 4 questions (DN4) | Postoperatively after 4 months of intensive treatment, at 1 year (after maintenance treatment) and at 1,5 years (after follow-up) | 
| Self-reported central sensitization symptoms | Measured with the Central Sensitization Inventory | Postoperatively after 4 months of intensive treatment, at 1 year (after maintenance treatment) and at 1,5 years (after follow-up) | 
| Altered somatosensory functions (touch) | Measured with Von Frey monofilaments | Postoperatively after 4 months of intensive treatment, at 1 year (after maintenance treatment) and at 1,5 years (after follow-up) | 
| Altered somatosensory functions (temperature) | Measured with computerized thermotests | Postoperatively after 4 months of intensive treatment, at 1 year (after maintenance treatment) and at 1,5 years (after follow-up) | 
| Altered somatosensory functions (nociception: pinprick sensation) | Measured with Von Frey monofilaments | Postoperatively after 4 months of intensive treatment, at 1 year (after maintenance treatment) and at 1,5 years (after follow-up) | 
| Altered somatosensory functions (nociception: deep pain sensitivity) | Measured with algometer | Postoperatively after 4 months of intensive treatment, at 1 year (after maintenance treatment) and at 1,5 years (after follow-up) | 
| Widespread pain | Measured with Quantitative Sensory Tests | Postoperatively after 4 months of intensive treatment, at 1 year (after maintenance treatment) and at 1,5 years (after follow-up) | 
| Endogenous pain facilitation assessed by a temporal summation paradigm | Measured with repetitive pinprick stimuli (using Von Frey Monofilament) | Postoperatively after 4 months of intensive treatment, at 1 year (after maintenance treatment) and at 1,5 years (after follow-up) | 
| Endogenous pain inhibition assessed by a conditioned pain modulation paradigm | Measured with TSA-II NeuroSensory Analyzer from Medoc | Postoperatively after 4 months of intensive treatment, at 1 year (after maintenance treatment) and at 1,5 years (after follow-up) | 
| Self-reported upper limb function | Measured with Disability of Arm, Shoulder and Hand Questionnaire | Postoperatively after 4 months of intensive treatment, at 1 year (after maintenance treatment) and at 1,5 years (after follow-up) | 
| General physical activity level and upper limb performance | Measured using accelerometers | Postoperatively after 4 months of intensive treatment, at 1 year (after maintenance treatment) and at 1,5 years (after follow-up) | 
| Self-reported emotional functioning: pain catastrophizing | Measured with the Pain Catastrophizing scale | Postoperatively after 4 months of intensive treatment, at 1 year (after maintenance treatment) and at 1,5 years (after follow-up) | 
| Self-reported emotional functioning: depression, anxiety and stress | Measured with Depression Anxiety Stress scales 21 | Postoperatively after 4 months of intensive treatment, at 1 year (after maintenance treatment) and at 1,5 years (after follow-up) | 
| Self-reported health-related quality of life | Measured with the McGill Quality of Life questionnaire | Postoperatively after 4 months of intensive treatment, at 1 year (after maintenance treatment) and at 1,5 years (after follow-up) | 
| Socio-economic outcomes: patients perceived ability to work | Measured with the Return-to-work self-efficacy questionnaire | Postoperatively after 4 months of intensive treatment, at 1 year (after maintenance treatment) and at 1,5 years (after follow-up) | 
| Socio-economic outcomes: return to work | Measured with the Return-to-work questionnaire | Postoperatively after 4 months of intensive treatment, at 1 year (after maintenance treatment) and at 1,5 years (after follow-up) | 
| Socio-economic outcomes: health-related costs | Self-reported questionnaire and data including health-care expenditure from publicly funded healthcare organizations and medical files | Postoperatively after 4 months of intensive treatment, at 1 year (after maintenance treatment) and at 1,5 years (after follow-up) |