The Effect of Pain Neuroscience Education and Behavioural Graded Activity on Chronic Pain in Breast Cancer Survivors
- Conditions
- SurvivorsChronic PainBreast Neoplasms
- Interventions
- Other: Usual careOther: Pain Neuroscience EducationOther: Behavioural Graded Activity
- Registration Number
- NCT04531917
- Lead Sponsor
- Universitair Ziekenhuis Brussel
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 122
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Usual care Usual care Patients allocated to the control group will receive an information leaflet from "Kom op tegen kanker" regarding "Pain in and after cancer". Pain Neuroscience Education + Behavioural Graded Activity Pain Neuroscience Education 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. Pain Neuroscience Education + Behavioural Graded Activity 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.
- Primary Outcome Measures
Name Time Method Self-reported pain intensity and pain interference T5: 2 years after intervention (week 116) * Measured with the 'Brief Pain Inventory'
* The minimum and maximum values: 0, 10
* Higher score means a worse outcomeChange in pain intensity and pain interference T1: baseline (within one week before randomisation) and T3: 3 months after intervention (w 26) Change between baseline (T1) and 3 months post-intervention (T3)
* Measured with the 'Brief Pain Inventory'
* The minimum and maximum values: 0, 10
* Higher score means a worse outcome
- Secondary Outcome Measures
Name Time Method Temperature detection threshold T1: baseline (within one week before randomisation), T2: after finishing intervention (w 13) and T3: 3 months after intervention (w 26) Assessed by the Medoc TSA-II Neurosensory Analyzer.
Pain detection threshold T1: baseline (within one week before randomisation), T2: after finishing intervention (w 13) and T3: 3 months after intervention (w 26) Assessed by the digital algometer, the Medoc TSA-II Neurosensory Analyzer and a manual blood pressure cuff.
Self-reported health-related quality of life 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) * Measured with the 'European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC-QLQ-C30)'
* The minimum and maximum values: 0, 100
* Higher score means a better outcomePain tolerance threshold T1: baseline (within one week before randomisation), T2: after finishing intervention (w 13) and T3: 3 months after intervention (w 26) Assessed by a manual blood pressure cuff.
Endogenous pain facilitation T1: baseline (within one week before randomisation), T2: after finishing intervention (w 13) and T3: 3 months after intervention (w 26) 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.
Endogenous pain inhibition T1: baseline (within one week before randomisation), T2: after finishing intervention (w 13) and T3: 3 months after intervention (w 26) 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.
Trial Locations
- Locations (1)
Vrije Universiteit Brussel (VUB)
🇧🇪Jette, Brussel, Belgium