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

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

Interventions

BEHAVIORAL

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.

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.

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.

Sponsors & Collaborators

• Vrije Universiteit Brussel

  collaborator OTHER

• Kom Op Tegen Kanker

  collaborator OTHER

• Hasselt University

  collaborator OTHER

• Universitair Ziekenhuis Brussel

  lead OTHER

Principal Investigators

• Jo Nijs, Prof. Dr. · Vrije Universiteit Brussel

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-04-01

Primary Completion

2025-09-28

Completion

2026-09-30

Countries

• Belgium

Study Locations