The Effect of Pain Neuroscience Education and Behavioural Graded Activity on Chronic Pain in Breast Cancer Survivors (BCS-PAIN)

Universitair Ziekenhuis Brussel

Status: Active, not recruiting

Conditions: Chronic Pain; Survivors; Breast Neoplasms

Treatments: Other: Usual care; Other: Pain Neuroscience Education; Other: Behavioural Graded Activity

Study type: Interventional

Funder types: Other

Identifiers

NCT04531917

11B1920N_BCS-PAIN

Details and patient eligibility

About

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.

Enrollment: 122 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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122 participants in 2 patient groups

Pain Neuroscience Education + Behavioural Graded Activity

Experimental group

Description:

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.

Treatment:

Other: Behavioural Graded Activity

Other: Pain Neuroscience Education

Usual care

Active Comparator group

Description:

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

Treatment:

Other: Usual care