Clinical trial NCT04531917: The Effect of Pain Neuroscience Education and Behavioural Graded Activity on Chronic Pain in Breast Cancer Survivors
Official title: The Effect of Pain Neuroscience Education and Behavioural Graded Activity Compared to Usual Care on Chronic Pain in Breast Cancer Survivors: a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Breast Neoplasms
Survivors
Chronic Pain
Keywords: Behavioural Graded Activity
Pain Neuroscience Education
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
Collaborators: name: Fund for Scientific Research, Flanders, Belgium
name: Vrije Universiteit Brussel
First posted: 2020-08-31
Enrollment: 122
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Chronic pain in breast cancer survivors (BCS) is of considerable concern as it impacts the health-related quality of life (HRQoL) and activities of daily living negatively. Over the past decades, awareness has raised the value of pain neuroscience education (PNE) in chronic pain. However, pain education remains underused in oncology and is often restricted to a biomedical management, which falls short in explaining persistent pain following cancer. Since PNE alone has rather small effect sizes, it should ideally be combined with a physical part, 'behavioural graded activity' (BGA). Therefore, the purpose of this study is to investigate the effectiveness of PNE with BGA compared to usual care on chronic pain in BCS.

A multi-centre, parallel, two-arm, double-blinded superiority with a three months intervention and two years follow-up will be conducted in 200 BCS with chronic pain. These will be randomly assigned to the intervention or usual care group. The intervention group will receive 6 sessions, in which PNE and BGA will be integrated. Whereas, the usual care group will receive an information leaflet regarding "Pain in and after cancer".

The primary objective of the present study is to examine whether the combination of PNE and BGA has an added value in decreasing the pain intensity compared to the usual care in BCS with chronic pain. The secondary objectives are to investigate whether the combination of PNE and BGA has the ability to reduce endogenous hyperalgesia and improve HRQoL compared to the usual care in BCS with chronic pain.


Eligibility criteria: Inclusion Criteria:

* To meet the definition introduced by the National Cancer Institute's Office of Cancer Survivorship, in which a cancer survivor is a patient with a history of cancer that is beyond the acute diagnosis and treatment phase. Patients need to be cancer-free and should have finished their primary treatment with a curative intent for at least 3 months prior to study participation. Adjuvant hormonal therapy and immunotherapy form the exception to the rule and are tolerated.
* To report a pain severity of at least 3 out of 10 on pain visual analogue scale.
* To be able to speak and read in Dutch in order to give informed consent and to complete the assessment tools. Written and signed consent will be obtained from all participants.

Exclusion Criteria:

* Suffering from dementia or cognitive impairment (unable to understand the test instructions and/or Mini Mental State Examination score \<23/30).
* Suffering from severe psychological or psychiatric diseases.
* Diagnosis of new neoplasms or metastases.

Primary outcomes:
measure: Change in pain intensity and pain interference
timeFrame: T1: baseline (within one week before randomisation) and T3: 3 months after intervention (w 26)
measure: Self-reported pain intensity and pain interference
timeFrame: T1: baseline (within one week before randomisation)
measure: Self-reported pain intensity and pain interference
timeFrame: T2: after finishing intervention (week 13)
measure: Self-reported pain intensity and pain interference
timeFrame: T3: 3 months after intervention (week 26)
measure: Self-reported pain intensity and pain interference
timeFrame: T4: 1 year after intervention (week 64)
measure: Self-reported pain intensity and pain interference
timeFrame: T5: 2 years after intervention (week 116)
Secondary outcomes:
measure: Self-reported health-related quality of life
timeFrame: T1: baseline (within one week before randomisation), T2: after finishing intervention (w 13), T3: 3 months after intervention (w 26), T4: 1 year after intervention (w 64) and T5: 2 years after intervention (w 116)
measure: Temperature detection threshold
timeFrame: T1: baseline (within one week before randomisation), T2: after finishing intervention (w 13) and T3: 3 months after intervention (w 26)
measure: Pain detection threshold
timeFrame: T1: baseline (within one week before randomisation), T2: after finishing intervention (w 13) and T3: 3 months after intervention (w 26)
measure: Pain tolerance threshold
timeFrame: T1: baseline (within one week before randomisation), T2: after finishing intervention (w 13) and T3: 3 months after intervention (w 26)
measure: Endogenous pain inhibition
timeFrame: T1: baseline (within one week before randomisation), T2: after finishing intervention (w 13) and T3: 3 months after intervention (w 26)
measure: Endogenous pain facilitation
timeFrame: T1: baseline (within one week before randomisation), T2: after finishing intervention (w 13) and T3: 3 months after intervention (w 26)
Other outcomes:
measure: Self-reported pain
timeFrame: T1: baseline (within one week before randomisation), T2: after finishing intervention (w 13), T3: 3 months after intervention (w 26), T4: 1 year after intervention (w 64) and T5: 2 years after intervention (w 116)
measure: Self-reported neuropathic pain
timeFrame: T1: baseline (within one week before randomisation), T2: after finishing intervention (w 13), T3: 3 months after intervention (w 26), T4: 1 year after intervention (w 64) and T5: 2 years after intervention (w 116)
measure: Self-reported central sensitization
timeFrame: T1: baseline (within one week before randomisation), T2: after finishing intervention (w 13), T3: 3 months after intervention (w 26), T4: 1 year after intervention (w 64) and T5: 2 years after intervention (w 116)
measure: Self-reported physical activity level
timeFrame: T1: baseline (within one week before randomisation), T2: after finishing intervention (w 13), T3: 3 months after intervention (w 26), T4: 1 year after intervention (w 64) and T5: 2 years after intervention (w 116)
measure: Self-reported physical activity level
timeFrame: During the intervention and T2: after finishing intervention (w 13)
measure: Self-reported sleep quality
timeFrame: T1: baseline (within one week before randomisation), T2: after finishing intervention (w 13), T3: 3 months after intervention (w 26), T4: 1 year after intervention (w 64) and T5: 2 years after intervention (w 116)
measure: Self-reported insomnia severity
timeFrame: T1: baseline (within one week before randomisation), T2: after finishing intervention (w 13), T3: 3 months after intervention (w 26), T4: 1 year after intervention (w 64) and T5: 2 years after intervention (w 116)
measure: Self-reported fatigue
timeFrame: T1: baseline (within one week before randomisation), T2: after finishing intervention (w 13), T3: 3 months after intervention (w 26), T4: 1 year after intervention (w 64) and T5: 2 years after intervention (w 116)
measure: Self-reported pain cognitions (pain catastrophizing)
timeFrame: T1: baseline (within one week before randomisation), T2: after finishing intervention (w 13), T3: 3 months after intervention (w 26), T4: 1 year after intervention (w 64) and T5: 2 years after intervention (w 116)
measure: Self-reported pain cognitions (perceived injustice)
timeFrame: T1: baseline (within one week before randomisation), T2: after finishing intervention (w 13), T3: 3 months after intervention (w 26), T4: 1 year after intervention (w 64) and T5: 2 years after intervention (w 116)
measure: Self-reported pain cognitions (illness perception)
timeFrame: T1: baseline (within one week before randomisation), T2: after finishing intervention (w 13), T3: 3 months after intervention (w 26), T4: 1 year after intervention (w 64) and T5: 2 years after intervention (w 116)
measure: Self-reported pain cognitions (pain vigilance and awareness)
timeFrame: T1: baseline (within one week before randomisation), T2: after finishing intervention (w 13), T3: 3 months after intervention (w 26), T4: 1 year after intervention (w 64) and T5: 2 years after intervention (w 116)
measure: Self-reported depression
timeFrame: T1: baseline (within one week before randomisation), T2: after finishing intervention (w 13), T3: 3 months after intervention (w 26), T4: 1 year after intervention (w 64) and T5: 2 years after intervention (w 116)
measure: Self-reported anxiety
timeFrame: T1: baseline (within one week before randomisation), T2: after finishing intervention (w 13), T3: 3 months after intervention (w 26), T4: 1 year after intervention (w 64) and T5: 2 years after intervention (w 116)
measure: Self-reported stress
timeFrame: T1: baseline (within one week before randomisation), T2: after finishing intervention (w 13), T3: 3 months after intervention (w 26), T4: 1 year after intervention (w 64) and T5: 2 years after intervention (w 116)
measure: Treatment adherence
timeFrame: During the intervention and T2: after finishing intervention (w 13)
measure: Treatment compliance
timeFrame: During the intervention and T2: after finishing intervention (w 13)
measure: The presence of axillary web syndrome
timeFrame: T1: baseline (within one week before randomisation)
measure: The presence of lymphedema
timeFrame: T1: baseline (within one week before randomisation)
measure: The presence of arthralgia
timeFrame: T1: baseline (within one week before randomisation)
measure: Detection of inflammation or adhesion of the scar tissue
timeFrame: T1: baseline (within one week before randomisation)
measure: Self-reported health care cost
timeFrame: T1: baseline (within one week before randomisation), T2: after finishing intervention (w 13), T3: 3 months after intervention (w 26), T4: 1 year after intervention (w 64) and T5: 2 years after intervention (w 116)
measure: Self-reported work absenteeism and productivity loss at work
timeFrame: T1: baseline (within one week before randomisation), T2: after finishing intervention (w 13), T3: 3 months after intervention (w 26), T4: 1 year after intervention (w 64) and T5: 2 years after intervention (w 116)
measure: Self-reported overall health status
timeFrame: T1: baseline (within one week before randomisation), T2: after finishing intervention (w 13), T3: 3 months after intervention (w 26), T4: 1 year after intervention (w 64) and T5: 2 years after intervention (w 116)
measure: Patient specific questionnaire
timeFrame: T1: baseline (within one week before randomisation)
Locations:
city: Jette
country: Belgium
facility: Vrije Universiteit Brussel (VUB)
state: Brussel
Study officials:
affiliation: Vrije Universiteit Brussel
name: Jo Nijs, Prof.
role: PRINCIPAL_INVESTIGATOR
References: