PI-targeted PNE+MI Compared to BIOMEDICAL Education in BCS (BCS-PI)
Breast Neoplasms, Survivorship, Pain, Chronic
About this trial
This is an interventional treatment trial for Breast Neoplasms focused on measuring Breast cancer survivor, Perceived injustice, Pain Neuroscience Education, Motivational Interviewing, Biomedical Education
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:
- 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).
Exclusion Criteria
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.
Sites / Locations
- AZ RivierenlandRecruiting
- Vrije Universiteit BrusselRecruiting
- Universiteit Hasselt - campus DiepenbeekRecruiting
- ImeldaziekenhuisRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Pain Neuroscience Education (PNE) + Motivational Interviewing (MI)
Biomedically-focused Education
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.
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.