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Chronic Pain Canada

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

Active, not recruitingNot applicableNCT04730154
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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 pa…

Study details

Official title
The Effect of Perceived Injustice Targeted Pain Neuroscience Education and Motivational Interviewing Compared to Biomedical Focused Education in Breast Cancer Survivors
Conditions
Interventions
Sponsor
Universitair Ziekenhuis Brussel
Collaborators
Vrije Universiteit Brussel; Kom Op Tegen Kanker; Hasselt University
Start date
2021-04-01
Primary completion
2025-09-28
Sex
Female
Age range
from 18 Years
Healthy volunteers
true
Results posted
No results posted in this snapshot
Countries
Belgium
Total sites listed
4

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
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.

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04730154