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

NCT04730154 | Active Not Recruiting

• 1 other identifier: ANI251_BCS-PI
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 4

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

Keywords

Breast cancer survivor; Perceived injustice; Pain Neuroscience Education; Motivational Interviewing; Biomedical Education

Outcome Measures

Primary Outcomes (5)

• 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).

  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).

  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).

  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).

  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).

  T4: 24 months after therapy completion

Secondary Outcomes (3)

• Health-related quality of life (HR-QoL)

  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)

  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)

  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

Other Outcomes (13)

• Sleep quality

  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

• Sleep insomnia

  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

• Fatigue severity

  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

Study Arms (2)

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.

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.

Behavioral: Biomedically-focused education

Interventions

Motivational Interviewing (MI) 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.

Pain Neuroscience Education (PNE) + Motivational Interviewing (MI)

Biomedically-focused education BEHAVIORAL

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

Biomedically-focused Education

Pain Neuroscience Education (PNE) 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.

Pain Neuroscience Education (PNE) + Motivational Interviewing (MI)

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vrije Universiteit Brussel: collaborator
• Universitair Ziekenhuis Brussel: lead
• Kom Op Tegen Kanker: collaborator
• Hasselt University: collaborator

Study Sites (4)

AZ Rivierenland

Bornem, Antwerpen, 2880, Belgium

Location

Vrije Universiteit Brussel

Jette, Brussels Capital, 1090, Belgium

Location

Universiteit Hasselt - campus Diepenbeek

Diepenbeek, Limburg, 3590, Belgium

Location

Imeldaziekenhuis

Bonheiden, Vlaams-Brabant, 2820, Belgium

Location

Related Publications (2)

• 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.

  PMID: 40629158 DERIVED

• 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.

  PMID: 38233049 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Chronic Pain

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Jo Nijs, Prof. Dr.

  Vrije Universiteit Brussel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2021
• First Posted: January 29, 2021
• Study Start: April 1, 2021
• Primary Completion: September 28, 2025
• Study Completion (Estimated): September 1, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The generated research data (both raw and processed data), the accompanying metadata and all documentation necessary to reuse the data will be transferred to the VUB University Archive server (K-drive) designed for long-term data archiving (managed by VUB ICTS with automatic back-up procedures). We will adhere to the principle of preservation of data and the policy of VUB (Vrije Universiteit Brussel) is to use a preservation term of 10 years, which we will apply. Data will be available upon publication of the research results until 10 years after.
• Access Criteria: Upon request by mail

Locations

BE (4)