PI-targeted PNE+MI Compared to BIOMEDICAL Education in BCS

NCT ID: NCT04730154

Last Updated: 2025-04-02

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 156 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-01
• Study Completion Date: 2025-12-31

Brief 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. 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.

Conditions

Breast Neoplasms; Survivorship; Pain, Chronic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Pain Neuroscience Education (PNE) + 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.

Group Type: EXPERIMENTAL

Pain Neuroscience Education (PNE)

Intervention Type: BEHAVIORAL

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)

Intervention Type: BEHAVIORAL

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 Education

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.

Group Type: ACTIVE_COMPARATOR

Biomedically-focused education

Intervention Type: BEHAVIORAL

The traditional biomedical-focused education programme explains patient's pain experience from a tissue (injured versus healthy tissue) and biomechanical perspective.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

Biomedically-focused education

The traditional biomedical-focused education programme explains patient's pain experience from a tissue (injured versus healthy tissue) and biomechanical perspective.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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:

1. Be women aged 18 years or older.

2. 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.

3. Report a pain severity of at least 3/10 on the Brief Pain Inventory.

4. Be able to speak and read Dutch in order to give informed consent and to complete the assessment tools.

5. Show evidence of perceived injustice, defined as a score of 17 or higher on the Injustice Experience Questionnaire (IEQ).

Exclusion Criteria

Participants will be excluded if they:

1. Are diagnosed with new neoplasms or metastases.

2. Have not reached the stable level of a chronic disease and/or which is causing pain complaints (e.g. fibromyalgia, rheumatoid arthritis…).

3. Are suffering from severe psychological or psychiatric diseases.

4. 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.

5. Recently started a new therapy which has not yet resulted in a stable level and might interference with one of the treatments.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Vrije Universiteit Brussel

OTHER

Sponsor Role: collaborator

Kom Op Tegen Kanker

OTHER

Sponsor Role: collaborator

Hasselt University

OTHER

Sponsor Role: collaborator

Universitair Ziekenhuis Brussel

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jo Nijs, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Vrije Universiteit Brussel

Locations

AZ Rivierenland

Bornem, Antwerpen, Belgium

Vrije Universiteit Brussel

Jette, Brussels Capital, Belgium

Universiteit Hasselt - campus Diepenbeek

Diepenbeek, Limburg, Belgium

Imeldaziekenhuis

Bonheiden, Vlaams-Brabant, Belgium

Countries

Belgium

References

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.

Reference Type: DERIVED

PMID: 40629158 (View on PubMed)

Roose 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.

Reference Type: DERIVED

PMID: 38233049 (View on PubMed)

Other Identifiers

ANI251_BCS-PI

Identifier Type: -

Identifier Source: org_study_id