Breast NeoplasmsBCS-PAINNCT04531917
The Effect of Pain Neuroscience Education and Behavioural Graded Activity on Chronic Pain in Breast Cancer Survivors
A study testing Pain Neuroscience Education and Behavioural Graded Activity in people with Breast Neoplasms and Survivors, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Neoplasms, Survivors, Chronic Pain
- What is being tested?
- Pain Neuroscience Education and Behavioural Graded Activity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteBelgium
- Study dates
- 12 Oct 2020to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Breast Neoplasms, Survivors, Chronic Pain
- Being tested
- Pain Neuroscience Education, Behavioural Graded Activity, Usual care
- Keywords
- Behavioural Graded Activity, Pain Neuroscience Education
- Medical subject headings
- Breast Neoplasms, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain Neuroscience EducationOther
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.
Behavioural Graded ActivityOther
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.
Usual careOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Pain Neuroscience Education + Behavioural Graded Activity | Experimental | 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. Receives: Other: Pain Neuroscience Education; Other: Behavioural Graded Activity |
| Usual care | Active comparator | Patients allocated to the control group will receive an information leaflet from "Kom op tegen kanker" regarding "Pain in and after cancer". Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain intensity and pain interference
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
Measured: T1: baseline (within one week before randomisation) and T3: 3 months after intervention (w 26)
Self-reported pain intensity and pain interference
- Measured with the 'Brief Pain Inventory'
- The minimum and maximum values: 0, 10
- Higher score means a worse outcome
Measured: T1: baseline (within one week before randomisation)
Self-reported pain intensity and pain interference
- Measured with the 'Brief Pain Inventory'
- The minimum and maximum values: 0, 10
- Higher score means a worse outcome
Measured: T2: after finishing intervention (week 13)
Self-reported pain intensity and pain interference
- Measured with the 'Brief Pain Inventory'
- The minimum and maximum values: 0, 10
- Higher score means a worse outcome
Measured: T3: 3 months after intervention (week 26)
Self-reported pain intensity and pain interference
- Measured with the 'Brief Pain Inventory'
- The minimum and maximum values: 0, 10
- Higher score means a worse outcome
Measured: T4: 1 year after intervention (week 64)
Self-reported pain intensity and pain interference
- Measured with the 'Brief Pain Inventory'
- The minimum and maximum values: 0, 10
- Higher score means a worse outcome
Measured: T5: 2 years after intervention (week 116)
Secondary outcomes (6)
Self-reported health-related quality of life
- 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 outcome
Measured: 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)
Temperature detection threshold
Assessed by the Medoc TSA-II Neurosensory Analyzer.
Measured: T1: baseline (within one week before randomisation), T2: after finishing intervention (w 13) and T3: 3 months after intervention (w 26)
Pain detection threshold
Assessed by the digital algometer, the Medoc TSA-II Neurosensory Analyzer and a manual blood pressure cuff.
Measured: T1: baseline (within one week before randomisation), T2: after finishing intervention (w 13) and T3: 3 months after intervention (w 26)
Pain tolerance threshold
Assessed by a manual blood pressure cuff.
Measured: T1: baseline (within one week before randomisation), T2: after finishing intervention (w 13) and T3: 3 months after intervention (w 26)
Endogenous pain inhibition
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.
Measured: T1: baseline (within one week before randomisation), T2: after finishing intervention (w 13) and T3: 3 months after intervention (w 26)
Endogenous pain facilitation
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.
Measured: T1: baseline (within one week before randomisation), T2: after finishing intervention (w 13) and T3: 3 months after intervention (w 26)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2020
- Study start12 Oct 2020
- Primary completionDec 2026 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by Universitair Ziekenhuis BrusselThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Collaborators
- Fund for Scientific Research, Flanders, Belgium, Vrije Universiteit Brussel
- Responsible party
- Sponsor
- Investigators
- Jo Nijs, Prof., Principal investigator, Vrije Universiteit Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04531917
- Sponsor's protocol ID
- 11B1920N_BCS-PAIN
- Acronym
- BCS-PAIN
- Status last verified
- Mar 2026
- First submitted
- 18 Aug 2020
- Last updated
- 16 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04531917
- Acronym / sponsor ID
- BCS-PAIN / 11B1920N_BCS-PAIN
- Conditions
- Breast Neoplasms, Survivors, Chronic Pain
- Keywords
- Behavioural Graded Activity, Pain Neuroscience Education
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Collaborators
- Fund for Scientific Research, Flanders, Belgium, Vrije Universiteit Brussel
- Study start
- 12 Oct 2020 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 31 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pain Neuroscience Education + Behavioural Graded Activity | Experimental | Other: Pain Neuroscience Education, Other: Behavioural Graded ActivityPatients 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. |
| Usual care | Active comparator | Other: Usual carePatients allocated to the control group will receive an information leaflet from "Kom op tegen kanker" regarding "Pain in and after cancer". |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pain Neuroscience EducationPain 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. | Other | Pain Neuroscience Education + Behavioural Graded Activity |
| Behavioural Graded ActivityPatients 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. | Other | Pain Neuroscience Education + Behavioural Graded Activity |
| Usual careThe 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. | Other | Usual care |
Primary outcome
Change in pain intensity and pain interference
Time frame: 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
Self-reported pain intensity and pain interference
Time frame: T1: baseline (within one week before randomisation)
* Measured with the 'Brief Pain Inventory' * The minimum and maximum values: 0, 10 * Higher score means a worse outcome
Self-reported pain intensity and pain interference
Time frame: T2: after finishing intervention (week 13)
* Measured with the 'Brief Pain Inventory' * The minimum and maximum values: 0, 10 * Higher score means a worse outcome
Self-reported pain intensity and pain interference
Time frame: T3: 3 months after intervention (week 26)
* Measured with the 'Brief Pain Inventory' * The minimum and maximum values: 0, 10 * Higher score means a worse outcome
Self-reported pain intensity and pain interference
Time frame: T4: 1 year after intervention (week 64)
* Measured with the 'Brief Pain Inventory' * The minimum and maximum values: 0, 10 * Higher score means a worse outcome
Self-reported pain intensity and pain interference
Time frame: 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 outcome
6 secondary outcomes
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)
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)
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)
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)
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)
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jo Nijs, Prof. principal investigator
Vrije Universiteit Brussel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pain Neuroscience Education and Behavioural Graded Activity in people with Breast Neoplasms and Survivors, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain intensity and pain interference (time frame: T1: baseline (within one week before randomisation) and T3: 3 months after intervention (w 26)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.