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