- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04531917
The Effect of Pain Neuroscience Education and Behavioural Graded Activity on Chronic Pain in Breast Cancer Survivors (BCS-PAIN)
The Effect of Pain Neuroscience Education and Behavioural Graded Activity Compared to Usual Care on Chronic Pain in Breast Cancer Survivors: a Randomised Controlled Trial
Chronic pain in breast cancer survivors (BCS) is of considerable concern as it impacts the health-related quality of life (HRQoL) and activities of daily living negatively. Over the past decades, awareness has raised the value of pain neuroscience education (PNE) in chronic pain. However, pain education remains underused in oncology and is often restricted to a biomedical management, which falls short in explaining persistent pain following cancer. Since PNE alone has rather small effect sizes, it should ideally be combined with a physical part, 'behavioural graded activity' (BGA). Therefore, the purpose of this study is to investigate the effectiveness of PNE with BGA compared to usual care on chronic pain in BCS.
A multi-centre, parallel, two-arm, double-blinded superiority with a three months intervention and two years follow-up will be conducted in 200 BCS with chronic pain. These will be randomly assigned to the intervention or usual care group. The intervention group will receive 6 sessions, in which PNE and BGA will be integrated. Whereas, the usual care group will receive an information leaflet regarding "Pain in and after cancer".
The primary objective of the present study is to examine whether the combination of PNE and BGA has an added value in decreasing the pain intensity compared to the usual care in BCS with chronic pain. The secondary objectives are to investigate whether the combination of PNE and BGA has the ability to reduce endogenous hyperalgesia and improve HRQoL compared to the usual care in BCS with chronic pain.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Laurence Leysen, Dr.
- Phone Number: Belgium +32 2477 43 26
- Email: Laurence.Leysen@vub.be
Study Contact Backup
- Name: Astrid Lahousse, Dra.
- Phone Number: Belgium +32 2477 45 30
- Email: astrid.lucie.lahousse@vub.be
Study Locations
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Brussel
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Jette, Brussel, Belgium, 1090
- Vrije Universiteit Brussel (VUB)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- To meet the definition introduced by the National Cancer Institute's Office of Cancer Survivorship, in which a cancer survivor is a patient with a history of cancer that is beyond the acute diagnosis and treatment phase. Patients need to be cancer-free and should have finished their primary treatment with a curative intent for at least 3 months prior to study participation. Adjuvant hormonal therapy and immunotherapy form the exception to the rule and are tolerated.
- To report a pain severity of at least 3 out of 10 on pain visual analogue scale.
- To be able to speak and read in Dutch in order to give informed consent and to complete the assessment tools. Written and signed consent will be obtained from all participants.
Exclusion Criteria:
- Suffering from dementia or cognitive impairment (unable to understand the test instructions and/or Mini Mental State Examination score <23/30).
- Suffering from severe psychological or psychiatric diseases.
- Diagnosis of new neoplasms or metastases.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Pain Neuroscience Education + Behavioural Graded Activity
Patients allocated to the intervention group will receive a 12-week treatment program that consists of 6 sessions, in which 'Pain Neuroscience Education' and 'Behavioural Graded Activity' will be integrated.
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Pain Neuroscience Education (PNE) teaches patients about complex pain mechanisms known to be of importance in pain following breast cancer such as malfunctioning of the endogenous analgesic system and pain memories.
Patients in the experimental group will receive a behavioural treatment integrated within the concepts of operant conditioning.
The purpose of Behavioural Graded Activity (BGA) is to increase the level of physical activity in the patient's daily lives in a time-contingent manner.
On top of that, a healthy behaviour will be positively reinforced to consequently create a withdrawal of the attention towards pain behaviour, which is seen as an unreliable "alarm sign" in chronic pain patients.
The implementation of BGA after PNE is described in the guideline reported by the International Association for the Study of Pain.
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Active Comparator: Usual care
Patients allocated to the control group will receive an information leaflet from "Kom op tegen kanker" regarding "Pain in and after cancer".
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The content of the leaflet has a biomedical approach in explaining pain and providing information on the different pain medication classes.
This leaflet is mostly available in waiting rooms of oncology centres and units of the Flemish part of Belgium.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in pain intensity and pain interference
Time Frame: T1: baseline (within one week before randomisation) and T3: 3 months after intervention (w 26)
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Change between baseline (T1) and 3 months post-intervention (T3)
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T1: baseline (within one week before randomisation) and T3: 3 months after intervention (w 26)
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Self-reported pain intensity and pain interference
Time Frame: T1: baseline (within one week before randomisation)
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T1: baseline (within one week before randomisation)
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Self-reported pain intensity and pain interference
Time Frame: T2: after finishing intervention (week 13)
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T2: after finishing intervention (week 13)
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Self-reported pain intensity and pain interference
Time Frame: T3: 3 months after intervention (week 26)
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T3: 3 months after intervention (week 26)
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Self-reported pain intensity and pain interference
Time Frame: T4: 1 year after intervention (week 64)
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T4: 1 year after intervention (week 64)
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Self-reported pain intensity and pain interference
Time Frame: T5: 2 years after intervention (week 116)
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T5: 2 years after intervention (week 116)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Self-reported health-related quality of life
Time Frame: T1: baseline (within one week before randomisation), T2: after finishing intervention (w 13), T3: 3 months after intervention (w 26), T4: 1 year after intervention (w 64) and T5: 2 years after intervention (w 116)
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T1: baseline (within one week before randomisation), T2: after finishing intervention (w 13), T3: 3 months after intervention (w 26), T4: 1 year after intervention (w 64) and T5: 2 years after intervention (w 116)
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Temperature detection threshold
Time Frame: T1: baseline (within one week before randomisation), T2: after finishing intervention (w 13) and T3: 3 months after intervention (w 26)
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Assessed by the Medoc TSA-II Neurosensory Analyzer.
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T1: baseline (within one week before randomisation), T2: after finishing intervention (w 13) and T3: 3 months after intervention (w 26)
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Pain detection threshold
Time Frame: T1: baseline (within one week before randomisation), T2: after finishing intervention (w 13) and T3: 3 months after intervention (w 26)
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Assessed by the digital algometer, the Medoc TSA-II Neurosensory Analyzer and a manual blood pressure cuff.
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T1: baseline (within one week before randomisation), T2: after finishing intervention (w 13) and T3: 3 months after intervention (w 26)
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Pain tolerance threshold
Time Frame: T1: baseline (within one week before randomisation), T2: after finishing intervention (w 13) and T3: 3 months after intervention (w 26)
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Assessed by a manual blood pressure cuff.
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T1: baseline (within one week before randomisation), T2: after finishing intervention (w 13) and T3: 3 months after intervention (w 26)
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Endogenous pain inhibition
Time Frame: T1: baseline (within one week before randomisation), T2: after finishing intervention (w 13) and T3: 3 months after intervention (w 26)
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Assessed objectively by conditioned pain modulation paradigm.
A manual blood pressure is the conditioned stimulus, and the digital algometer and the Medoc TSA-II Neurosensory Analyzer are testing stimuli.
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T1: baseline (within one week before randomisation), T2: after finishing intervention (w 13) and T3: 3 months after intervention (w 26)
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Endogenous pain facilitation
Time Frame: T1: baseline (within one week before randomisation), T2: after finishing intervention (w 13) and T3: 3 months after intervention (w 26)
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Assessed objectively by temporal summation paradigm.
Ten testing stimuli will be applied, and subjects will be asked to rate their pain intensity on the first, fifth and tenth stimulus by using the Visual Analogue Scale.
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T1: baseline (within one week before randomisation), T2: after finishing intervention (w 13) and T3: 3 months after intervention (w 26)
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Self-reported pain
Time Frame: T1: baseline (within one week before randomisation), T2: after finishing intervention (w 13), T3: 3 months after intervention (w 26), T4: 1 year after intervention (w 64) and T5: 2 years after intervention (w 116)
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T1: baseline (within one week before randomisation), T2: after finishing intervention (w 13), T3: 3 months after intervention (w 26), T4: 1 year after intervention (w 64) and T5: 2 years after intervention (w 116)
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Self-reported neuropathic pain
Time Frame: T1: baseline (within one week before randomisation), T2: after finishing intervention (w 13), T3: 3 months after intervention (w 26), T4: 1 year after intervention (w 64) and T5: 2 years after intervention (w 116)
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T1: baseline (within one week before randomisation), T2: after finishing intervention (w 13), T3: 3 months after intervention (w 26), T4: 1 year after intervention (w 64) and T5: 2 years after intervention (w 116)
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Self-reported central sensitization
Time Frame: T1: baseline (within one week before randomisation), T2: after finishing intervention (w 13), T3: 3 months after intervention (w 26), T4: 1 year after intervention (w 64) and T5: 2 years after intervention (w 116)
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T1: baseline (within one week before randomisation), T2: after finishing intervention (w 13), T3: 3 months after intervention (w 26), T4: 1 year after intervention (w 64) and T5: 2 years after intervention (w 116)
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Self-reported physical activity level
Time Frame: T1: baseline (within one week before randomisation), T2: after finishing intervention (w 13), T3: 3 months after intervention (w 26), T4: 1 year after intervention (w 64) and T5: 2 years after intervention (w 116)
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T1: baseline (within one week before randomisation), T2: after finishing intervention (w 13), T3: 3 months after intervention (w 26), T4: 1 year after intervention (w 64) and T5: 2 years after intervention (w 116)
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Self-reported physical activity level
Time Frame: During the intervention and T2: after finishing intervention (w 13)
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During the intervention and T2: after finishing intervention (w 13)
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Self-reported sleep quality
Time Frame: T1: baseline (within one week before randomisation), T2: after finishing intervention (w 13), T3: 3 months after intervention (w 26), T4: 1 year after intervention (w 64) and T5: 2 years after intervention (w 116)
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T1: baseline (within one week before randomisation), T2: after finishing intervention (w 13), T3: 3 months after intervention (w 26), T4: 1 year after intervention (w 64) and T5: 2 years after intervention (w 116)
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Self-reported insomnia severity
Time Frame: T1: baseline (within one week before randomisation), T2: after finishing intervention (w 13), T3: 3 months after intervention (w 26), T4: 1 year after intervention (w 64) and T5: 2 years after intervention (w 116)
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T1: baseline (within one week before randomisation), T2: after finishing intervention (w 13), T3: 3 months after intervention (w 26), T4: 1 year after intervention (w 64) and T5: 2 years after intervention (w 116)
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Self-reported fatigue
Time Frame: T1: baseline (within one week before randomisation), T2: after finishing intervention (w 13), T3: 3 months after intervention (w 26), T4: 1 year after intervention (w 64) and T5: 2 years after intervention (w 116)
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T1: baseline (within one week before randomisation), T2: after finishing intervention (w 13), T3: 3 months after intervention (w 26), T4: 1 year after intervention (w 64) and T5: 2 years after intervention (w 116)
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Self-reported pain cognitions (pain catastrophizing)
Time Frame: T1: baseline (within one week before randomisation), T2: after finishing intervention (w 13), T3: 3 months after intervention (w 26), T4: 1 year after intervention (w 64) and T5: 2 years after intervention (w 116)
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T1: baseline (within one week before randomisation), T2: after finishing intervention (w 13), T3: 3 months after intervention (w 26), T4: 1 year after intervention (w 64) and T5: 2 years after intervention (w 116)
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Self-reported pain cognitions (perceived injustice)
Time Frame: T1: baseline (within one week before randomisation), T2: after finishing intervention (w 13), T3: 3 months after intervention (w 26), T4: 1 year after intervention (w 64) and T5: 2 years after intervention (w 116)
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T1: baseline (within one week before randomisation), T2: after finishing intervention (w 13), T3: 3 months after intervention (w 26), T4: 1 year after intervention (w 64) and T5: 2 years after intervention (w 116)
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Self-reported pain cognitions (illness perception)
Time Frame: T1: baseline (within one week before randomisation), T2: after finishing intervention (w 13), T3: 3 months after intervention (w 26), T4: 1 year after intervention (w 64) and T5: 2 years after intervention (w 116)
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T1: baseline (within one week before randomisation), T2: after finishing intervention (w 13), T3: 3 months after intervention (w 26), T4: 1 year after intervention (w 64) and T5: 2 years after intervention (w 116)
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Self-reported pain cognitions (pain vigilance and awareness)
Time Frame: T1: baseline (within one week before randomisation), T2: after finishing intervention (w 13), T3: 3 months after intervention (w 26), T4: 1 year after intervention (w 64) and T5: 2 years after intervention (w 116)
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T1: baseline (within one week before randomisation), T2: after finishing intervention (w 13), T3: 3 months after intervention (w 26), T4: 1 year after intervention (w 64) and T5: 2 years after intervention (w 116)
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Self-reported depression
Time Frame: T1: baseline (within one week before randomisation), T2: after finishing intervention (w 13), T3: 3 months after intervention (w 26), T4: 1 year after intervention (w 64) and T5: 2 years after intervention (w 116)
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T1: baseline (within one week before randomisation), T2: after finishing intervention (w 13), T3: 3 months after intervention (w 26), T4: 1 year after intervention (w 64) and T5: 2 years after intervention (w 116)
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Self-reported anxiety
Time Frame: T1: baseline (within one week before randomisation), T2: after finishing intervention (w 13), T3: 3 months after intervention (w 26), T4: 1 year after intervention (w 64) and T5: 2 years after intervention (w 116)
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T1: baseline (within one week before randomisation), T2: after finishing intervention (w 13), T3: 3 months after intervention (w 26), T4: 1 year after intervention (w 64) and T5: 2 years after intervention (w 116)
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Self-reported stress
Time Frame: T1: baseline (within one week before randomisation), T2: after finishing intervention (w 13), T3: 3 months after intervention (w 26), T4: 1 year after intervention (w 64) and T5: 2 years after intervention (w 116)
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T1: baseline (within one week before randomisation), T2: after finishing intervention (w 13), T3: 3 months after intervention (w 26), T4: 1 year after intervention (w 64) and T5: 2 years after intervention (w 116)
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Treatment adherence
Time Frame: During the intervention and T2: after finishing intervention (w 13)
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Patient adherence for the treatment sessions will be calculated as the ratio of the number of treatment sessions that were actually carried out versus the number of prescribed sessions.
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During the intervention and T2: after finishing intervention (w 13)
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Treatment compliance
Time Frame: During the intervention and T2: after finishing intervention (w 13)
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Compliance will be calculated as the ratio of the total training duration (recorded in the logbooks) versus the prescribed total training duration, multiplied by 100.
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During the intervention and T2: after finishing intervention (w 13)
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The presence of axillary web syndrome
Time Frame: T1: baseline (within one week before randomisation)
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The diagnosis of Axillary Web Syndrome (AWS) will be made clinically.
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T1: baseline (within one week before randomisation)
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The presence of lymphedema
Time Frame: T1: baseline (within one week before randomisation)
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Lymphedema will be clinically diagnosed: The Stemmer sign is positive if the assessor is unable to pinch (between his/her thumb and index finger) the dorsal skin of proximal phalanx (second or third finger). A positive test confirms the presence of primary and secondary lymphedema of the arm(s). Single circumference measurement will only be performed if unilateral lymphedema is suspected. The arm circumference will be measured by a nylon tape measure with an accuracy of 1mm. The tape measure will be placed around the arm without tightening the tape at 30cm above the styloid process. Lymphedema is present if there is at least a difference of 10% between both arms. |
T1: baseline (within one week before randomisation)
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The presence of arthralgia
Time Frame: T1: baseline (within one week before randomisation)
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To assess arthralgia the assessor will ask the patient two questions: "Do you experience symmetrical pain in the left and right shoulders, elbows, wrists, fingers, hips, knees, ankles and/or toes?" and "Do you experience morning stiffness?
And if so, for how many minutes?"
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T1: baseline (within one week before randomisation)
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Detection of inflammation or adhesion of the scar tissue
Time Frame: T1: baseline (within one week before randomisation)
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The scar tissue will be clinically scored.
First, the assessor will inspect the affected (and painful) region for possible skin damage and will be looking for: wound disruption, hematoma (bruising), abscess (cavity filled with pus) and seroma (cavity filled with transparent liquid).
Second, the he will inspect the presence of a possible inflammation process of the scar tissue and will be looking for signs such as: warmth, redness, etc. Third, he will assess the mobility of the scar.
During this manual test, will be assessed whether the scar is moving relative to the underlying layers, which will be scored on a 5-point Likert scale with response possibilities: (totally disagree, disagree, don't disagree/agree, agree, totally agree).
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T1: baseline (within one week before randomisation)
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Self-reported health care cost
Time Frame: T1: baseline (within one week before randomisation), T2: after finishing intervention (w 13), T3: 3 months after intervention (w 26), T4: 1 year after intervention (w 64) and T5: 2 years after intervention (w 116)
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T1: baseline (within one week before randomisation), T2: after finishing intervention (w 13), T3: 3 months after intervention (w 26), T4: 1 year after intervention (w 64) and T5: 2 years after intervention (w 116)
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Self-reported work absenteeism and productivity loss at work
Time Frame: T1: baseline (within one week before randomisation), T2: after finishing intervention (w 13), T3: 3 months after intervention (w 26), T4: 1 year after intervention (w 64) and T5: 2 years after intervention (w 116)
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T1: baseline (within one week before randomisation), T2: after finishing intervention (w 13), T3: 3 months after intervention (w 26), T4: 1 year after intervention (w 64) and T5: 2 years after intervention (w 116)
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Self-reported overall health status
Time Frame: T1: baseline (within one week before randomisation), T2: after finishing intervention (w 13), T3: 3 months after intervention (w 26), T4: 1 year after intervention (w 64) and T5: 2 years after intervention (w 116)
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T1: baseline (within one week before randomisation), T2: after finishing intervention (w 13), T3: 3 months after intervention (w 26), T4: 1 year after intervention (w 64) and T5: 2 years after intervention (w 116)
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Patient specific questionnaire
Time Frame: T1: baseline (within one week before randomisation)
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Self-administered questions about: gender, ethnicity, age, nationality, weight, height, civil state, mutuality, educational level, year of the breast cancer diagnosis, received breast cancer treatments, lymphedema, medication, other treatments, menopausal, hot flashes.
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T1: baseline (within one week before randomisation)
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jo Nijs, Prof., Vrije Universiteit Brussel
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 11B1920N_BCS-PAIN
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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