The Effect of Pain Neuroscience Education and Behavioural Graded Activity on Chronic Pain in Breast Cancer Survivors

Condition(s) studied

Investigational drug(s) / intervention(s)

Pain Neuroscience Education: Pain Neuroscience Education (PNE) teaches patients about complex pain mechanisms known to be of importance in pain following breast cancer such as malfunctioning of the endogenous analgesic system and pain memories.

Behavioural Graded Activity: Patients in the experimental group will receive a behavioural treatment integrated within the concepts of operant conditioning. The purpose of Behavioural Graded Activity (BGA) is to increase the level of physical activity in the patient's daily lives in a time-contingent manner. On top of that, a healthy behaviour will be positively reinforced to consequently create a withdrawal of the attention towards pain behaviour, which is seen as an unreliable "alarm sign" in chronic pain patients. The implementation of BGA after PNE is described in the guideline reported by the International Association for the Study of Pain.

Usual care: The content of the leaflet has a biomedical approach in explaining pain and providing information on the different pain medication classes. This leaflet is mostly available in waiting rooms of oncology centres and units of the Flemish part of Belgium.

Study 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

Primary outcome measure(s)

• Change in pain intensity and pain interference — T1: baseline (within one week before randomisation) and T3: 3 months after intervention (w 26)
  Change between baseline (T1) and 3 months post-intervention (T3) * Measured with the 'Brief Pain Inventory' * The minimum and maximum values: 0, 10 * Higher score means a worse outcome
• Self-reported pain intensity and pain interference — T1: baseline (within one week before randomisation)
  * Measured with the 'Brief Pain Inventory' * The minimum and maximum values: 0, 10 * Higher score means a worse outcome
• Self-reported pain intensity and pain interference — T2: after finishing intervention (week 13)
  * Measured with the 'Brief Pain Inventory' * The minimum and maximum values: 0, 10 * Higher score means a worse outcome
• Self-reported pain intensity and pain interference — T3: 3 months after intervention (week 26)
  * Measured with the 'Brief Pain Inventory' * The minimum and maximum values: 0, 10 * Higher score means a worse outcome
• Self-reported pain intensity and pain interference — T4: 1 year after intervention (week 64)
  * Measured with the 'Brief Pain Inventory' * The minimum and maximum values: 0, 10 * Higher score means a worse outcome
• Self-reported pain intensity and pain interference — T5: 2 years after intervention (week 116)
  * Measured with the 'Brief Pain Inventory' * The minimum and maximum values: 0, 10 * Higher score means a worse outcome

Trial sites (1)

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