Clinical trial NCT04730154: PI-targeted PNE+MI Compared to BIOMEDICAL Education in BCS
Official title: The Effect of Perceived Injustice Targeted Pain Neuroscience Education and Motivational Interviewing Compared to Biomedical Focused Education in Breast Cancer Survivors
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Breast Neoplasms
Survivorship
Pain, Chronic
Keywords: Breast cancer survivor
Perceived injustice
Pain Neuroscience Education
Motivational Interviewing
Biomedical Education
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
Collaborators: name: Vrije Universiteit Brussel
name: Kom Op Tegen Kanker
name: Hasselt University
First posted: 2021-01-29
Enrollment: 156
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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:

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.

Primary outcomes:
measure: Pain Outcome
timeFrame: T0: within the week before the randomisation and the start of the intervention
measure: Pain Outcome
timeFrame: T1: immediately after completing intervention
measure: Pain Outcome
timeFrame: T2: 6 months after therapy completion
measure: Pain Outcome
timeFrame: T3: 12 months after therapy completion
measure: Pain Outcome
timeFrame: T4: 24 months after therapy completion
Secondary outcomes:
measure: Health-related quality of life (HR-QoL)
timeFrame: 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
measure: Perceived injustice (PI)
timeFrame: 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
measure: Health care utilization (HCU)
timeFrame: 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
Other outcomes:
measure: Sleep quality
timeFrame: 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
measure: Sleep insomnia
timeFrame: 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
measure: Fatigue severity
timeFrame: 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
measure: Pain catastrophizing
timeFrame: 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
measure: Pain cognitions
timeFrame: 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
measure: Pain behaviour
timeFrame: 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
measure: Depression, Anxiety, Stress
timeFrame: 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
measure: Anger
timeFrame: 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
measure: Acceptance
timeFrame: 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
measure: Treatment adherence and compliance
timeFrame: During intervention period (after T0 and before T1)
measure: Co-interventions
timeFrame: 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
measure: Personal characteristics
timeFrame: T0: within the week before the randomisation and the start of the intervention
measure: Screening dementia or cognitive impairment
timeFrame: During screening period; before T0
Locations:
city: Bornem
country: Belgium
facility: AZ Rivierenland
state: Antwerpen
city: Jette
country: Belgium
facility: Vrije Universiteit Brussel
state: Brussel
city: Diepenbeek
country: Belgium
facility: Universiteit Hasselt - campus Diepenbeek
state: Limburg
city: Bonheiden
country: Belgium
facility: Imeldaziekenhuis
state: Vlaams-Brabant
Study officials:
affiliation: Vrije Universiteit Brussel
name: Jo Nijs, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: