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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04730154
Recruitment Status : Recruiting
First Posted : January 29, 2021
Last Update Posted : May 18, 2022
Sponsor:
Collaborators:
Vrije Universiteit Brussel
Kom Op Tegen Kanker
Hasselt University
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Breast Neoplasms Survivorship Pain, Chronic Behavioral: Pain Neuroscience Education (PNE) Behavioral: Motivational Interviewing (MI) Behavioral: Biomedically-focused education Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 156 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Perceived Injustice Targeted Pain Neuroscience Education and Motivational Interviewing Compared to Biomedical Focused Education in Breast Cancer Survivors
Actual Study Start Date : April 1, 2021
Estimated Primary Completion Date : April 2023
Estimated Study Completion Date : April 2024


Arm Intervention/treatment
Experimental: Pain Neuroscience Education (PNE) + 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.
Behavioral: Pain 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.

Behavioral: Motivational 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.

Active Comparator: 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.
Behavioral: Biomedically-focused education
The traditional biomedical-focused education programme explains patient's pain experience from a tissue (injured versus healthy tissue) and biomechanical perspective.




Primary Outcome Measures :
  1. Pain Outcome [ Time Frame: 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).

  2. Pain Outcome [ Time Frame: T1: immediately after completing 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).

  3. Pain Outcome [ Time Frame: T2: 6 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).

  4. Pain Outcome [ Time Frame: T3: 12 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).

  5. Pain Outcome [ Time Frame: 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 :
  1. Health-related quality of life (HR-QoL) [ Time Frame: 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.

  2. Perceived injustice (PI) [ Time Frame: 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.


  3. Health care utilization (HCU) [ Time Frame: 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).



Other Outcome Measures:
  1. Sleep quality [ Time Frame: 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 ]
    Pittsburgh Sleep Quality Index (PSQI): is a self-rated questionnaire to measure sleep quality and disturbance over 1 month. It is based on 19 items which generate a global score, ranging between 0 and 21, and 7 component scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. Scores above 5 signifies a poor sleeper. It is a reliable and valid measurement tool and internal consistency is acceptable in breast cancer population (Cronbach's alpha = 0.80).

  2. Sleep insomnia [ Time Frame: 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 ]
    Insomnia Severity Index (ISI): is a questionnaire to detect cases of insomnia and asses the insomnia severity of both night-time and daytime components of insomnia. It is based on 7 items measured on a 5-point Likert scale (0-4) which generates a total score ranging from 0 (no insomnia) to 28 (great insomnia severity). The cut-off score of 10 is optimal for detecting insomnia cases and a change score of -8.4 points is associated with a moderate improvement. ISI is a valid and reliable instrument in cancer patients and had an adequate concurrent validity of (r = 0,65).

  3. Fatigue severity [ Time Frame: 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 ]
    Fatigue Severity Scale (FSS): is used to evaluate global fatigue severity in a number of chronic medical conditions such as palliative cancer. It is a short questionnaire with 9-items and the total score ranges between 9 (no fatigue) and 63 (maximum fatigue). The FSS is a reliable and valid measurement in cancer patients. The internal consistency of the FSS is highly acceptable (Cronbach's alpha = 0.96).

  4. Pain catastrophizing [ Time Frame: 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 ]
    Pain Catastrophizing Scale (PCS): is a self-reported questionnaire to assess catastrophic thoughts or feelings accompanying the previously experienced pain. It is a 13-item measure that evaluates 3 subscales of catastrophizing: rumination, magnification and helplessness on a 5-point Likert scale. This scale ranges from 0 (not at all) to 4 (all the time) with a total score between 0 and 52. The PCS factor scales are valid and reliable.

  5. Pain cognitions [ Time Frame: 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 ]
    Brief Illness Perceptions Questionnaire-Dutch Language Version (Brief IPQ-DLV): measures five illness perceptions and consists nine items. Five items assess cognitive illness (consequences, personal control, treatment control and identity), two items assess emotional perceptions (concern and emotions), one item assesses illness comprehensibility and one item assesses causal perception. The first eight items are rated on a 10-point Likert scale and the ninth item is rated as an open-ended question which asks to list three most important causal factors in the illness. The Brief IPQ-DLV has acceptable psychometric properties. The Smallest Detectable Change (SDC) is 3 point for item 1 to 8.

  6. Pain behaviour [ Time Frame: 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 ]
    Pain Vigilance and Awareness Questionnaire (PVAQ): is designed to consider behaviour over the last 2 weeks in chronic pain patients. It consists 16-items that assesses attention to pain. The frequency of each item is rated on a 6-point Likert scale ranging from 0 (never) to 5 (always) with a total score ranges between 0 and 90. The higher the score, the more suggestive for a higher degree of vigilance and awareness to pain. It is highly correlated with pain-related measures such as catastrophizing, and weakly correlated with measures of unrelated constructs, such as trait anxiety. The PVAQ is a reliable and valid measurement in chronic patients.

  7. Depression, Anxiety, Stress [ Time Frame: 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 ]
    Depression, Anxiety, Stress Scale 21 items (DASS-21): is an instrument that is used to assess anxiety and depression. Twenty-one items are subdivided in 3 categories: depression (7 items), anxiety (7 items) and stress (7 items). Each item is scored on a 4-point Likert scale ranging from 0 (not at all) to 3 (most of the time). The higher the item score, the more severe symptom of psychological distress is identified. The total score, used for the interpretation, is the sum of all items multiplied by two. The DASS-21 is a valid and reliable assessment tool in cancer patients.

  8. Anger [ Time Frame: 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 ]
    State-Trait Anger Expression Inventory-II (STAXI-II): is a self-reported 57-item questionnaire that assesses the level and frequency of anger experience, expression and control. It consists three parts: (a) how angry the examinee currently feels, (b) how angry the examinee generally feels, and (c) how the examinee reacts when angry. Every item in each subscale is assessed on a 4-point Likert-scale. The validity and reliability of the STAXI-II questionnaire are satisfactory supported.

  9. Acceptance [ Time Frame: 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 ]
    Acceptance and Action Questionnaire - II (AAQ-II): is a self-reported 7-item questionnaire that assesses the amount of acceptance and experiential avoidance, or its opposite: psychological flexibility. Every item is a statement that is scored on a 7-point Likert-scale in which one can indicate to what extent these are applicable. The higher the total score, the lower the acceptance and the higher the experiential avoidance. The psychometric qualities of the Dutch translation of the AAQ-II are good with an internal reliability of 0.87 and a construct validity of -0.67 to -0.79 for oppression and psychological complaints.

  10. Treatment adherence and compliance [ Time Frame: During intervention period (after T0 and before T1) ]
    Patients' attendance at treatment sessions will be recorded. Patient adherence for the treatment sessions will be calculated as the ratio of the number of treatment sessions that were actually carried out versus the number of prescribed sessions. For the home sessions (incl. working with the information leaflet), patients will be asked to record the sessions' content in a personal log book. Treatment adherence will be calculated as a ratio of the number of sessions that were actually carried out at home versus the total number of prescribed home sessions. Patient drop-out and the reason for withdrawal will be registered.

  11. Co-interventions [ Time Frame: T0: within the week before randomisation and start of intervention; during intervention; T1: immediately after completing intervention; T2: 6 months after therapy completion; T3: 12 months after therapy completion; T4: 24 months after therapy completion ]
    Co-interventions will be closely monitored. Medical consumption, including the type, dose, method of administration and frequency of medication, as well as any other interventions will be recorded.

  12. Personal characteristics [ Time Frame: T0: within the week before the randomisation and the start of the intervention ]
    Personal characteristics including date of birth, nationality, race/ethnicity, level of education, professional situation, family income, relationship status, physical activity, smoking status, alcohol consumption, Body Mass Index (BMI), comorbidities, lymphedema, type of surgery, hormone therapy, chemotherapy, radiotherapy, immunotherapy, time since onset of complaints, time since complement of treatment, and treatment expectations will be collected at baseline.

  13. Screening dementia or cognitive impairment [ Time Frame: During screening period; before T0 ]
    Participants will be excluded if they 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
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:

  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04730154


Contacts
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Contact: Laurence Leysen, Prof. Dr. +32 2477 43 26 ext Belgium Laurence.Leysen@vub.be
Contact: Eva Roose, Dra. +32 2477 43 26 ext Belgium Eva.Charlotte.S.Roose@vub.be

Locations
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Belgium
AZ Rivierenland Recruiting
Bornem, Antwerpen, Belgium, 2880
Contact: Brenda De Petter, Dr.    03 890 16 11    brenda.de.petter@azr.be   
Vrije Universiteit Brussel Recruiting
Jette, Brussel, Belgium, 1090
Contact: Jo Nijs, Prof. Dr.       Jo.Nijs@vub.be   
Universiteit Hasselt - campus Diepenbeek Recruiting
Diepenbeek, Limburg, Belgium, 3590
Contact: Annick Timmermans, Prof. Dr.       Annick.Timmermans@uhasselt.be   
Imeldaziekenhuis Recruiting
Bonheiden, Vlaams-Brabant, Belgium, 2820
Contact: Carine De Rop, Dr.         
Sponsors and Collaborators
Universitair Ziekenhuis Brussel
Vrije Universiteit Brussel
Kom Op Tegen Kanker
Hasselt University
Investigators
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Principal Investigator: Jo Nijs, Prof. Dr. Vrije Universiteit Brussel
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Responsible Party: Universitair Ziekenhuis Brussel
ClinicalTrials.gov Identifier: NCT04730154    
Other Study ID Numbers: ANI251_BCS-PI
First Posted: January 29, 2021    Key Record Dates
Last Update Posted: May 18, 2022
Last Verified: May 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Universitair Ziekenhuis Brussel:
Breast cancer survivor
Perceived injustice
Pain Neuroscience Education
Motivational Interviewing
Biomedical Education
Additional relevant MeSH terms:
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Breast Neoplasms
Chronic Pain
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Pain
Neurologic Manifestations