Breast Neoplasms, Survivorship, Pain, Chronic
Conditions
Keywords
Breast cancer survivor, Perceived injustice, Pain Neuroscience Education, Motivational Interviewing, Biomedical Education
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.
Interventions
BEHAVIORALPain 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.
BEHAVIORALMotivational 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.
BEHAVIORALBiomedically-focused education
The traditional biomedical-focused education programme explains patient's pain experience from a tissue (injured versus healthy tissue) and biomechanical perspective.
Sponsors
Universitair Ziekenhuis Brussel
Vrije Universiteit Brussel
Kom Op Tegen Kanker
Hasselt University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Outcome | T0: within the week before the randomisation and the start of the intervention | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | The European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) is a 30-item cancer-specific questionnaire developed for the assessment of quality of life in cancer patients. The EORTC QLQ-C30 is widely used in cancer studies, has been translated and validated in over 100 languages and shows acceptable psychometric properties. The internal consistence measured by Cronbach's resulted in 0.94. |
| 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 | The 12-item Injustice Experience Questionnaire (IEQ) will be used to assess perceived injustice. Participants have to rate the frequency of 12 different pain-related statements on a 5-point Likert scale ranging from 0 (not at all) to 4 (all the time). The sum of all items gives the total score which ranges from 0 to 48. The cut off score of 19 is suggestive for a clinically relevant case of perceived injustice. This questionnaire obtains two correlated factors: severity/irreparability of loss and blame/unfairness. The Dutch version of the IEQ has good (test-retest) reliability (ICC = 0.86-0.87). The scores obtained using the IEQ are valid. |
| 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 | Medical consumption, the type, dose, method of administration and frequency of analgesic, NSAID or symptom-modifying medication, as well as surgeries will be recorded. Health care use will be evaluated using the combination of three questionnaires (online): 1. the Medical Consumption Questionnaire (MCQ) 2. the Productivity Cost Questionnaire (PCQ) 3. the EuroQol EQ-5D The combination of these questionnaires is advised by the Institute for Medical Technology Assessment, Erasmus University Rotterdam (the Netherlands). |
Countries
Belgium
Contacts
PRINCIPAL_INVESTIGATORJo Nijs, Prof. Dr.
Vrije Universiteit Brussel
Outcome results
None listed