PI-targeted PNE+MI Compared to BIOMEDICAL Education in BCS
- Conditions
- Breast NeoplasmsSurvivorshipPain, Chronic
- Interventions
- Behavioral: Biomedically-focused educationBehavioral: Pain Neuroscience Education (PNE)Behavioral: Motivational Interviewing (MI)
- Registration Number
- NCT04730154
- Lead Sponsor
- Universitair Ziekenhuis Brussel
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 156
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Biomedically-focused Education Biomedically-focused education 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. Pain Neuroscience Education (PNE) + Motivational Interviewing (MI) Pain Neuroscience Education (PNE) 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. Pain Neuroscience Education (PNE) + Motivational Interviewing (MI) Motivational Interviewing (MI) 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.
- Primary Outcome Measures
Name Time Method Pain Outcome T4: 24 months after therapy completion 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 Outcome Measures
Name Time Method 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).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-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.
Trial Locations
- Locations (4)
AZ Rivierenland
🇧🇪Bornem, Antwerpen, Belgium
Vrije Universiteit Brussel
🇧🇪Jette, Brussel, Belgium
Universiteit Hasselt - campus Diepenbeek
🇧🇪Diepenbeek, Limburg, Belgium
Imeldaziekenhuis
🇧🇪Bonheiden, Vlaams-Brabant, Belgium