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
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 122
- 试验地点
- 1
- 主要终点
- Self-reported pain intensity and pain interference
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Pain Neuroscience Education + Behavioural Graded Activity
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.
干预措施: Pain Neuroscience Education (Other)
Pain Neuroscience Education + Behavioural Graded Activity
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.
干预措施: Behavioural Graded Activity (Other)
Usual care
Patients allocated to the control group will receive an information leaflet from "Kom op tegen kanker" regarding "Pain in and after cancer".
干预措施: Usual care (Other)
结局指标
主要结局
Self-reported pain intensity and pain interference
时间窗: 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
Change in pain intensity and pain interference
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
次要结局
- 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))
- 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))
- 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 facilitation(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))