Breast NeoplasmsBCS-PINCT04730154
PI-targeted PNE+MI Compared to BIOMEDICAL Education in BCS
A study testing Pain Neuroscience Education (PNE), Motivational Interviewing (MI) and Biomedically-focused education in people with Breast Neoplasms and Survivorship, run by Universitair Ziekenhuis Brussel at 4 sites in Belgium.
Trial summary
Breast cancer is the most frequently diagnosed cancer in women worldwide. An important portion of the breast cancer survivors will face chronic pain complaints. These pain complaints do not only impact the patient's quality of life but also prevents resumption of activities, leading to huge economic costs. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Neoplasms, Survivorship, Pain, Chronic
- What is being tested?
- Pain Neuroscience Education (PNE), Motivational Interviewing (MI) and Biomedically-focused education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 4 sitesBelgium
- Study dates
- 1 Apr 2021to Sep 2026
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- In order to be eligible, participants have to fulfil the definition for survivorship introduced by the European Organisation of Research and Treatment of Cancer (EORTC) Survivorship Task Force, in which a cancer survivor is: 'any person who has been diagnosed with cancer, has completed his or her primary treatment (with the exception of maintenance therapy) and has no evidence of active disease'. Therefore, participants need to:
- Be women aged 18 years or older.
- Be in complete remission and should have finished their primary treatment with a curative intent at least 3 months prior to study participation. Adjuvant hormonal therapy and immunotherapy are tolerated.
- Report a pain severity of at least 3/10 on the Brief Pain Inventory.
- Be able to speak and read Dutch in order to give informed consent and to complete the assessment tools.
- Show evidence of perceived injustice, defined as a score of 17 or higher on the Injustice Experience Questionnaire (IEQ).
Who cannot join
- Participants will be excluded if they:
- Are diagnosed with new neoplasms or metastases.
- Have not reached the stable level of a chronic disease and/or which is causing pain complaints (e.g. fibromyalgia, rheumatoid arthritis…).
- Are suffering from severe psychological or psychiatric diseases.
- Are suffering from dementia or cognitive impairment (unable to understand the test instructions and/or a result of ≤11, corresponding with MMSE ≤23, on the Six-item Cognitive Impairment Test (6-item CIT) is a short questionnaire containing 6 items.
- Recently started a new therapy which has not yet resulted in a stable level and might interference with one of the treatments.
Trial locations and contacts
4 sites in 1 country.
Belgium4 sites
Imeldaziekenhuis
Bonheiden, Vlaams-Brabant, 2820
AZ Rivierenland
Bornem, Antwerpen, 2880
Universiteit Hasselt - campus Diepenbeek
Diepenbeek, Limburg, 3590
Vrije Universiteit Brussel
Jette, Brussels Capital, 1090
About this study
Official title: The Effect of Perceived Injustice Targeted Pain Neuroscience Education and Motivational Interviewing Compared to Biomedical Focused Education in Breast Cancer Survivors
Breast cancer is the most frequently diagnosed cancer in women worldwide. An important portion of the breast cancer survivors will face chronic pain complaints. These pain complaints do not only impact the patient's quality of life but also prevents resumption of activities, leading to huge economic costs. 30% of all breast cancer survivors with pain present with perceived injustice which has been conceptualized as a multidimensional appraisal process characterized by a tendency to interpret one's losses as severe and irreparable, to attribute blame to others for one's suffering and to experience a sense of unfairness. Perceived injustice is also associated with increased opioid prescription and use, urging the need for targeted interventions to diminish perceived injustice.
Despite the fact that specific treatment plans for perceived injustice are not yet proven, pain neuroscience education (PNE) is proven to reassure and encourage towards activity. In order to obtain the targeted behavioural change, motivational interviewing (MI) is used as the communication process throughout PNE.
Read more
A multi-centre, parallel, two-arm, investigator-blinded study with 4-weeks intervention and two years follow-up will be conducted in 156 BCS with PI and pain. These will be randomly assigned to the intervention or usual care group. The groups will receive 1 online session, an information leaflet and 3 live sessions of education spread over 4 weeks. Pain neuroscience education in combination with motivational interviewing will be given in the experimental group and biomedically-focused education to the control group.
The primary scientific objective of the study is to examine whether perceived injustice-targeted PNE is superior to biomedically-focused pain education in reducing pain after 12 months in breast cancer survivors with perceived injustice and pain.
The secondary objectives of the study are to examine whether perceived injustice-targeted PNE, compared to biomedically-focused pain education, results in improving health-related quality of life, reducing perceived injustice and opioid use after 24 months in breast cancer survivors with perceived injustice and pain, and to conduct a health-care cost analysis which will finally result in a recommendation concerning the use of perceived injustice-targeted PNE in breast cancer survivors with perceived injustice and pain.
- Conditions
- Breast Neoplasms, Survivorship, Pain, Chronic
- Being tested
- Pain Neuroscience Education (PNE), Motivational Interviewing (MI), Biomedically-focused education
- Keywords
- Breast cancer survivor, Perceived injustice, Pain Neuroscience Education, Motivational Interviewing, Biomedical 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 Education (PNE)Behavioural
PNE is a cognitive behavioural intervention, including educating patients that pain is an output product of the brain resulting from input from multiple central and peripheral nervous system processes and leading to threat perception. Transferring that knowledge to patients, allows them to understand, accept and effectively cope with their pain. In order to obtain the targeted behavioural change, motivational interviewing is used as the communication process throughout PNE.
Motivational Interviewing (MI)Behavioural
Motivational interviewing is a directive, collaborative, patient-centered communication approach for eliciting and enhancing motivation for behaviour change by helping clients to resolve ambivalence and uncertainty.
Biomedically-focused educationBehavioural
The traditional biomedical-focused education programme explains patient's pain experience from a tissue (injured versus healthy tissue) and biomechanical perspective.
| Study group | Role | What they receive |
|---|---|---|
| Pain Neuroscience Education (PNE) + Motivational Interviewing (MI) | Experimental | Breast cancer survivors assigned to the experimental intervention will participate in 1 online PNE session followed by 3 PNE + MI sessions spread over 4 weeks. Each session will last for approximately 45 minutes and all sessions will be held in one-on-one format, allowing to individually tailor content to the patient's maladaptive beliefs and perceived injustice. After the first live session, breast cancer survivors will receive a perceived injustice-targeted PNE information leaflet that they need to read carefully at home. Receives: Behavioral: Pain Neuroscience Education (PNE); Behavioral: Motivational Interviewing (MI) |
| Biomedically-focused Education | Active comparator | Breast cancer survivors assigned to the experimental intervention will participate in 1 online biomedically-focused education session followed by 3 biomedically-focused education sessions spread over 4 weeks. Each session will last for approximately 45 minutes and all sessions will be held in one-on-one format in order to balance nonspecific treatment effects between treatment arms, the duration, format and number of sessions as well as the didactical approach will be identical in both treatment groups. After the first live session, breast cancer survivors will receive an information leaflet from 'Kom op tegen Kanker' regarding 'Pain in and after treatment' that they need to read carefully at home. Receives: Behavioral: Biomedically-focused education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Outcome
The Brief Pain Inventory is a 14-item questionnaire assessing worst pain, pain severity, and pain interference in cancer patients over the past week, reported on a scale of 0 to 10. Pain interference is measured as the average of the 7 interference items, such as walking, mood, and sleep. The Brief Pain Inventory is the most common, reliable and valid outcome measure to assess pain in cancer survivors (Cronbach's alfa and test-retest reliability score > 0.80).
Measured: T0: within the week before the randomisation and the start of the intervention
Pain Outcome
The Brief Pain Inventory is a 14-item questionnaire assessing worst pain, pain severity, and pain interference in cancer patients over the past week, reported on a scale of 0 to 10. Pain interference is measured as the average of the 7 interference items, such as walking, mood, and sleep. The Brief Pain Inventory is the most common, reliable and valid outcome measure to assess pain in cancer survivors (Cronbach's alfa and test-retest reliability score > 0.80).
Measured: T1: immediately after completing intervention
Pain Outcome
The Brief Pain Inventory is a 14-item questionnaire assessing worst pain, pain severity, and pain interference in cancer patients over the past week, reported on a scale of 0 to 10. Pain interference is measured as the average of the 7 interference items, such as walking, mood, and sleep. The Brief Pain Inventory is the most common, reliable and valid outcome measure to assess pain in cancer survivors (Cronbach's alfa and test-retest reliability score > 0.80).
Measured: T2: 6 months after therapy completion
Pain Outcome
The Brief Pain Inventory is a 14-item questionnaire assessing worst pain, pain severity, and pain interference in cancer patients over the past week, reported on a scale of 0 to 10. Pain interference is measured as the average of the 7 interference items, such as walking, mood, and sleep. The Brief Pain Inventory is the most common, reliable and valid outcome measure to assess pain in cancer survivors (Cronbach's alfa and test-retest reliability score > 0.80).
Measured: T3: 12 months after therapy completion
Pain Outcome
The Brief Pain Inventory is a 14-item questionnaire assessing worst pain, pain severity, and pain interference in cancer patients over the past week, reported on a scale of 0 to 10. Pain interference is measured as the average of the 7 interference items, such as walking, mood, and sleep. The Brief Pain Inventory is the most common, reliable and valid outcome measure to assess pain in cancer survivors (Cronbach's alfa and test-retest reliability score > 0.80).
Measured: T4: 24 months after therapy completion
Secondary outcomes (3)
Health-related quality of life (HR-QoL)
The European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) is a 30-item cancer-specific questionnaire developed for the assessment of quality of life in cancer patients. The EORTC QLQ-C30 is widely used in cancer studies, has been translated and validated in over 100 languages and shows acceptable psychometric properties. The internal consistence measured by Cronbach's resulted in 0.94.
Measured: T0: within the week before the randomisation and the start of the intervention; T1: immediately after completing intervention; T2: 6 months after therapy completion; T3: 12 months after therapy completion; T4: 24 months after therapy completion
Perceived injustice (PI)
The 12-item Injustice Experience Questionnaire (IEQ) will be used to assess perceived injustice. Participants have to rate the frequency of 12 different pain-related statements on a 5-point Likert scale ranging from 0 (not at all) to 4 (all the time). The sum of all items gives the total score which ranges from 0 to 48. The cut off score of 19 is suggestive for a clinically relevant case of perceived injustice.
This questionnaire obtains two correlated factors: severity/irreparability of loss and blame/unfairness. The Dutch version of the IEQ has good (test-retest) reliability (ICC = 0.86-0.87). The scores obtained using the IEQ are valid.
Measured: T0: within the week before the randomisation and the start of the intervention; T1: immediately after completing intervention; T2: 6 months after therapy completion; T3: 12 months after therapy completion; T4: 24 months after therapy completion
Health care utilization (HCU)
Medical consumption, the type, dose, method of administration and frequency of analgesic, NSAID or symptom-modifying medication, as well as surgeries will be recorded. Health care use will be evaluated using the combination of three questionnaires (online):
- the Medical Consumption Questionnaire (MCQ)
- the Productivity Cost Questionnaire (PCQ)
- the EuroQol EQ-5D
The combination of these questionnaires is advised by the Institute for Medical Technology Assessment, Erasmus University Rotterdam (the Netherlands).
Measured: T0: within the week before the randomisation and the start of the intervention; T1: immediately after completing intervention; T2: 6 months after therapy completion; T3: 12 months after therapy completion; T4: 24 months after therapy completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2021
- Study start1 Apr 2021
- Primary completion28 Sep 2025
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- 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
- 156 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Collaborators
- Vrije Universiteit Brussel, Kom Op Tegen Kanker, Hasselt University
- Responsible party
- Sponsor
- Investigators
- Jo Nijs, Prof. Dr., Principal investigator, Vrije Universiteit Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04730154
- Sponsor's protocol ID
- ANI251_BCS-PI
- Acronym
- BCS-PI
- Status last verified
- Apr 2026
- First submitted
- 20 Jan 2021
- Last updated
- 6 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After the project, the data will be archived in the VUB University Archive with restricted access. Data sharing is only permitted if all involved parties agree, and a Data Sharing Agreement has been signed. Open Access will not be possible due to the high degree of confidentiality of the pseudonymized medical data, although all requests regarding sharing the research data will be considered by the parties. The university server is equipped with user-level access permission management. Participants' personal data will be coded, and system encryption will be used to protect the coded data. No costs are expected, but project and/or research group funds will cover any potential data sharing costs.
Publications
Roose E, Van Bogaert W, Mostaqim K, Huysmans E, Nijs J, van Wilgen CP, Beckwee D, Timmermans A, Fontaine C, Lahousse A. An exploration of the relationship between perceived injustice and pain severity in breast cancer survivors: a structural equation model. Support Care Cancer. 2025 Jul 9;33(8):670. doi: 10.1007/s00520-025-09655-8.
PubMed 40629158Roose E, Huysmans E, Leysen L, Mostaqim K, Van Wilgen P, Beckwee D, De Couck M, Timmermans A, Bults R, Nijs J, Lahousse A. Effect of perceived injustice-targeted pain neuroscience education compared with biomedically focused education in breast cancer survivors: a study protocol for a multicentre randomised controlled trial (BCS-PI trial). BMJ Open. 2024 Jan 17;14(1):e075779. doi: 10.1136/bmjopen-2023-075779.
PubMed 38233049
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Perceived Injustice Targeted Pain Neuroscience Education and Motivational Interviewing Compared to Biomedical Focused Education in Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT04730154
- Acronym / sponsor ID
- BCS-PI / ANI251_BCS-PI
- Conditions
- Breast Neoplasms, Survivorship, Pain, Chronic
- Keywords
- Breast cancer survivor, Perceived injustice, Pain Neuroscience Education, Motivational Interviewing, Biomedical Education
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 156 participants (estimated)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Collaborators
- Vrije Universiteit Brussel, Kom Op Tegen Kanker, Hasselt University
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 28 Sep 2025 (actual)
- Study completion
- Sep 2026 (estimated)
- First posted
- 29 Jan 2021 (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.
Breast cancer is the most frequently diagnosed cancer in women worldwide. An important portion of the breast cancer survivors will face chronic pain complaints. These pain complaints do not only impact the patient's quality of life but also prevents resumption of activities, leading to huge economic costs. 30% of all breast cancer survivors with pain present with perceived injustice which has been conceptualized as a multidimensional appraisal process characterized by a tendency to interpret one's losses as severe and irreparable, to attribute blame to others for one's suffering and to experience a sense of unfairness. Perceived injustice is also associated with increased opioid prescription and use, urging the need for targeted interventions to diminish perceived injustice.
Despite the fact that specific treatment plans for perceived injustice are not yet proven, pain neuroscience education (PNE) is proven to reassure and encourage towards activity. In order to obtain the targeted behavioural change, motivational interviewing (MI) is used as the communication process throughout PNE.
A multi-centre, parallel, two-arm, investigator-blinded study with 4-weeks intervention and two years follow-up will be conducted in 156 BCS with PI and pain. These will be randomly assigned to the intervention or usual care group. The groups will receive 1 online session, an information leaflet and 3 live sessions of education spread over 4 weeks. Pain neuroscience education in combination with motivational interviewing will be given in the experimental group and biomedically-focused education to the control group.
The primary scientific objective of the study is to examine whether perceived injustice-targeted PNE is superior to biomedically-focused pain education in reducing pain after 12 months in breast cancer survivors with perceived injustice and pain.
The secondary objectives of the study are to examine whether perceived injustice-targeted PNE, compared to biomedically-focused pain education, results in improving health-related quality of life, reducing perceived injustice and opioid use after 24 months in breast cancer survivors with perceived injustice and pain, and to conduct a health-care cost analysis which will finally result in a recommendation concerning the use of perceived injustice-targeted PNE in breast cancer survivors with perceived injustice and 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 (PNE) + Motivational Interviewing (MI) | Experimental | Behavioral: Pain Neuroscience Education (PNE), Behavioral: Motivational Interviewing (MI)Breast cancer survivors assigned to the experimental intervention will participate in 1 online PNE session followed by 3 PNE + MI sessions spread over 4 weeks. Each session will last for approximately 45 minutes and all sessions will be held in one-on-one format, allowing to individually tailor content to the patient's maladaptive beliefs and perceived injustice. After the first live session, breast cancer survivors will receive a perceived injustice-targeted PNE information leaflet that they need to read carefully at home. |
| Biomedically-focused Education | Active comparator | Behavioral: Biomedically-focused educationBreast cancer survivors assigned to the experimental intervention will participate in 1 online biomedically-focused education session followed by 3 biomedically-focused education sessions spread over 4 weeks. Each session will last for approximately 45 minutes and all sessions will be held in one-on-one format in order to balance nonspecific treatment effects between treatment arms, the duration, format and number of sessions as well as the didactical approach will be identical in both treatment groups. After the first live session, breast cancer survivors will receive an information leaflet from 'Kom op tegen Kanker' regarding 'Pain in and after treatment' that they need to read carefully at home. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- In order to be eligible, participants have to fulfil the definition for survivorship introduced by the European Organisation of Research and Treatment of Cancer (EORTC) Survivorship Task Force, in which a cancer survivor is: 'any person who has been diagnosed with cancer, has completed his or her primary treatment (with the exception of maintenance therapy) and has no evidence of active disease'. Therefore, participants need to:
- Be women aged 18 years or older.
- Be in complete remission and should have finished their primary treatment with a curative intent at least 3 months prior to study participation. Adjuvant hormonal therapy and immunotherapy are tolerated.
- Report a pain severity of at least 3/10 on the Brief Pain Inventory.
- Be able to speak and read Dutch in order to give informed consent and to complete the assessment tools.
Key exclusion criteria (6 listed)
- Are diagnosed with new neoplasms or metastases.
- Have not reached the stable level of a chronic disease and/or which is causing pain complaints (e.g. fibromyalgia, rheumatoid arthritis…).
- Are suffering from severe psychological or psychiatric diseases.
- Are suffering from dementia or cognitive impairment (unable to understand the test instructions and/or a result of ≤11, corresponding with MMSE ≤23, on the Six-item Cognitive Impairment Test (6-item CIT) is a short questionnaire containing 6 items.
- Recently started a new therapy which has not yet resulted in a stable level and might interference with one of the treatments.
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 Education (PNE)PNE is a cognitive behavioural intervention, including educating patients that pain is an output product of the brain resulting from input from multiple central and peripheral nervous system processes and leading to threat perception. Transferring that knowledge to patients, allows them to understand, accept and effectively cope with their pain. In order to obtain the targeted behavioural change, motivational interviewing is used as the communication process throughout PNE. | Behavioural | Pain Neuroscience Education (PNE) + Motivational Interviewing (MI) |
| Motivational Interviewing (MI)Motivational interviewing is a directive, collaborative, patient-centered communication approach for eliciting and enhancing motivation for behaviour change by helping clients to resolve ambivalence and uncertainty. | Behavioural | Pain Neuroscience Education (PNE) + Motivational Interviewing (MI) |
| Biomedically-focused educationThe traditional biomedical-focused education programme explains patient's pain experience from a tissue (injured versus healthy tissue) and biomechanical perspective. | Behavioural | Biomedically-focused Education |
Primary outcome
Pain Outcome
Time frame: T0: within the week before the randomisation and the start of the intervention
The Brief Pain Inventory is a 14-item questionnaire assessing worst pain, pain severity, and pain interference in cancer patients over the past week, reported on a scale of 0 to 10. Pain interference is measured as the average of the 7 interference items, such as walking, mood, and sleep. The Brief Pain Inventory is the most common, reliable and valid outcome measure to assess pain in cancer survivors (Cronbach's alfa and test-retest reliability score > 0.80).
Pain Outcome
Time frame: T1: immediately after completing intervention
The Brief Pain Inventory is a 14-item questionnaire assessing worst pain, pain severity, and pain interference in cancer patients over the past week, reported on a scale of 0 to 10. Pain interference is measured as the average of the 7 interference items, such as walking, mood, and sleep. The Brief Pain Inventory is the most common, reliable and valid outcome measure to assess pain in cancer survivors (Cronbach's alfa and test-retest reliability score > 0.80).
Pain Outcome
Time frame: T2: 6 months after therapy completion
The Brief Pain Inventory is a 14-item questionnaire assessing worst pain, pain severity, and pain interference in cancer patients over the past week, reported on a scale of 0 to 10. Pain interference is measured as the average of the 7 interference items, such as walking, mood, and sleep. The Brief Pain Inventory is the most common, reliable and valid outcome measure to assess pain in cancer survivors (Cronbach's alfa and test-retest reliability score > 0.80).
Pain Outcome
Time frame: T3: 12 months after therapy completion
The Brief Pain Inventory is a 14-item questionnaire assessing worst pain, pain severity, and pain interference in cancer patients over the past week, reported on a scale of 0 to 10. Pain interference is measured as the average of the 7 interference items, such as walking, mood, and sleep. The Brief Pain Inventory is the most common, reliable and valid outcome measure to assess pain in cancer survivors (Cronbach's alfa and test-retest reliability score > 0.80).
Pain Outcome
Time frame: T4: 24 months after therapy completion
The Brief Pain Inventory is a 14-item questionnaire assessing worst pain, pain severity, and pain interference in cancer patients over the past week, reported on a scale of 0 to 10. Pain interference is measured as the average of the 7 interference items, such as walking, mood, and sleep. The Brief Pain Inventory is the most common, reliable and valid outcome measure to assess pain in cancer survivors (Cronbach's alfa and test-retest reliability score > 0.80).
3 secondary outcomes
Health-related quality of life (HR-QoL)
Time frame: T0: within the week before the randomisation and the start of the intervention; T1: immediately after completing intervention; T2: 6 months after therapy completion; T3: 12 months after therapy completion; T4: 24 months after therapy completion
Perceived injustice (PI)
Time frame: T0: within the week before the randomisation and the start of the intervention; T1: immediately after completing intervention; T2: 6 months after therapy completion; T3: 12 months after therapy completion; T4: 24 months after therapy completion
Health care utilization (HCU)
Time frame: T0: within the week before the randomisation and the start of the intervention; T1: immediately after completing intervention; T2: 6 months after therapy completion; T3: 12 months after therapy completion; T4: 24 months after therapy completion
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 6 May 2026.
- Derived from this study: PubMed 40629158Roose E, Van Bogaert W, Mostaqim K, Huysmans E, Nijs J, van Wilgen CP, Beckwee D, Timmermans A, Fontaine C, Lahousse A. An exploration of the relationship between perceived injustice and pain severity in breast cancer survivors: a structural equation model. Support Care Cancer. 2025 Jul 9;33(8):670. doi: 10.1007/s00520-025-09655-8.
- Derived from this study: PubMed 38233049Roose E, Huysmans E, Leysen L, Mostaqim K, Van Wilgen P, Beckwee D, De Couck M, Timmermans A, Bults R, Nijs J, Lahousse A. Effect of perceived injustice-targeted pain neuroscience education compared with biomedically focused education in breast cancer survivors: a study protocol for a multicentre randomised controlled trial (BCS-PI trial). BMJ Open. 2024 Jan 17;14(1):e075779. doi: 10.1136/bmjopen-2023-075779.
- Individual participant dataSharing planned: Yes. After the project, the data will be archived in the VUB University Archive with restricted access. Data sharing is only permitted if all involved parties agree, and a Data Sharing Agreement has been signed. Open Access will not be possible due to the high degree of confidentiality of the pseudonymized medical data, although all requests regarding sharing the research data will be considered by the parties. The university server is equipped with user-level access permission management. Participants' personal data will be coded, and system encryption will be used to protect the coded data. No costs are expected, but project and/or research group funds will cover any potential data sharing costs.
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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. Dr. principal investigator
Vrije Universiteit Brussel
4 sites 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 (PNE), Motivational Interviewing (MI) and Biomedically-focused education in people with Breast Neoplasms and Survivorship, run by Universitair Ziekenhuis Brussel at 4 sites 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 6 inclusion and 6 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 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Pain Outcome (time frame: T0: within the week before the randomisation and the start of the intervention). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04730154, which also lists 2 linked publications.
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 6 May 2026.