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

NCT04531917 | Active Not Recruiting

• 1 other identifier: 11B1920N_BCS-PAIN
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain; Breast Neoplasms; Survivors

Keywords

Behavioural Graded Activity; Pain Neuroscience Education

Outcome Measures

Primary Outcomes (6)

• Change in pain intensity and pain interference

  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

  T1: baseline (within one week before randomisation) and T3: 3 months after intervention (w 26)

• Self-reported pain intensity and pain interference

  * Measured with the 'Brief Pain Inventory' * The minimum and maximum values: 0, 10 * Higher score means a worse outcome

  T1: baseline (within one week before randomisation)

• Self-reported pain intensity and pain interference

  * Measured with the 'Brief Pain Inventory' * The minimum and maximum values: 0, 10 * Higher score means a worse outcome

  T2: after finishing intervention (week 13)

• Self-reported pain intensity and pain interference

  * Measured with the 'Brief Pain Inventory' * The minimum and maximum values: 0, 10 * Higher score means a worse outcome

  T3: 3 months after intervention (week 26)

• Self-reported pain intensity and pain interference

  * Measured with the 'Brief Pain Inventory' * The minimum and maximum values: 0, 10 * Higher score means a worse outcome

  T4: 1 year after intervention (week 64)

• Self-reported pain intensity and pain interference

  * Measured with the 'Brief Pain Inventory' * The minimum and maximum values: 0, 10 * Higher score means a worse outcome

  T5: 2 years after intervention (week 116)

Secondary Outcomes (6)

• Self-reported health-related quality of life

  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)

• Temperature detection threshold

  T1: baseline (within one week before randomisation), T2: after finishing intervention (w 13) and T3: 3 months after intervention (w 26)

• Pain detection threshold

  T1: baseline (within one week before randomisation), T2: after finishing intervention (w 13) and T3: 3 months after intervention (w 26)

• Pain tolerance threshold

  T1: baseline (within one week before randomisation), T2: after finishing intervention (w 13) and T3: 3 months after intervention (w 26)

• Endogenous pain inhibition

  T1: baseline (within one week before randomisation), T2: after finishing intervention (w 13) and T3: 3 months after intervention (w 26)

Other Outcomes (25)

• Self-reported pain

  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)

• Self-reported neuropathic pain

  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)

• Self-reported central sensitization

  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)

Study Arms (2)

Pain Neuroscience Education + Behavioural Graded Activity

EXPERIMENTAL

Patients allocated to the intervention group will receive a 12-week treatment program that consists of 6 sessions, in which 'Pain Neuroscience Education' and 'Behavioural Graded Activity' will be integrated.

Other: Pain Neuroscience Education; Other: Behavioural Graded Activity

Usual care

ACTIVE COMPARATOR

Patients allocated to the control group will receive an information leaflet from "Kom op tegen kanker" regarding "Pain in and after cancer".

Other: Usual care

Interventions

Pain Neuroscience Education OTHER

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.

Pain Neuroscience Education + Behavioural Graded Activity

Usual care OTHER

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.

Usual care

Behavioural Graded Activity OTHER

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.

Pain Neuroscience Education + Behavioural Graded Activity

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vrije Universiteit Brussel: collaborator
• Universitair Ziekenhuis Brussel: lead
• Fund for Scientific Research, Flanders, Belgium: collaborator

Study Sites (1)

Vrije Universiteit Brussel (VUB)

Jette, Brussels Capital, 1090, Belgium

Location

MeSH Terms

Conditions

Breast Neoplasms; Chronic Pain

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jo Nijs, Prof.

  Vrije Universiteit Brussel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2020
• First Posted: August 31, 2020
• Study Start: October 12, 2020
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2028
• Last Updated: March 16, 2026

Record last verified: 2026-03

Locations

BE (1)