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临床试验/NCT04924010
NCT04924010已完成不适用

Effect of Perioperative Cognitive Behavioural Therapy on Chronic Persistent Postsurgical Pain Among Breast Cancer Patients With High Pain Catastrophising Characteristics: A Randomised, Double-blind Clinical Trial

Mater Misericordiae University Hospital2 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2021年5月31日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
48
试验地点
2
主要终点
Brief Pain Inventory (BPI) Short-form: average pain severity

研究概览

简要总结

Chronic persistent post-surgical pain (CPSP) is defined as pain at or near the site of surgery persisting for 3 months or more after the date of surgery. The incidence CPSP in Europe is up to 50% at 3 months and 12% at 12 months, but the incidence varies depending on surgical procedure [Fletcher D et al]. In Breast surgery, one of the most commonly performed surgical procedures for cancer [Kehlet H et al], CPSP has been observed in 20-30% of patients at 6 months after surgery, making this group among the highest risk of developing CPSP [Spivey TL et al & Weiser TG et al]. Clinical developments that could mitigate the development of CPSP after breast cancer surgery would potentially yield multiple benefits in terms of reducing future healthcare utilization, associated costs [Spivey Tl et al], and improving their physical and mental health.

Several predictive factors for CPSP have been identified, the most important being chronic pre-operative pain, high intensity of acute postoperative pain, and several psychological factors [Vranceanu A-M et al]. Of these psychological factors, pain catastrophizing has emerged as one of the strongest predictors of pain severity and disability among individuals with a range of pain presentations and CPSP [Leung L & Wade Jb & Wildeman TH]. Catastrophizing is described as a maladaptive psychological coping strategy involving an exaggerated reaction to anticipated or actual pain. It can involve mental rumination, magnification of the perceived danger or threat associated with pain, and feelings of helplessness in relation to what can be done [Leung L et al]. A recent systematic review on psychological interventions undergoing major elective abdominal surgery concluded catastrophization can have a direct influence on the neuropathophysiological mechanisms underlying pain experiences and can improve pain and psychological outcomes, after surgery [Villa G et al].

In recent years, there has been a growing number of studies investigating the potential impact of perioperative psychological interventions in a variety of patient groups. A recent systematic review and meta-analysis of observational studies concluded that psychological predictors may have a significant association with chronic postsurgical pain, including catastrophization, although this conclusion is limited by the heterogeneity of study designs and methods used [Giusti et al]. To our knowledge, no randomized controlled trial has been done to date, investigating the influence of perioperative psychological interventions on CPSP in patients undergoing breast cancer surgery.

详细描述

This will be a single-center, prospective, double-blinded, randomized controlled trial. The study will randomize breast cancer surgery patients into two groups: one that receives perioperative cognitive-behavioral therapy (CBT) in addition to usual care and the other receives an educational program. The estimated duration for the main investigational plan (e.g. from the start of screening of the first participant to the last participant processed and finishing the study) is one year.

Aims and objectives:

The primary objective is to examine whether a perioperative CBT-based psychological intervention is effective at reducing pain intensity at three-month follow-up, in high catastrophizing patients undergoing breast cancer surgery, compared to an education program.

Secondary objectives of the study include examining whether perioperative CBT has a demonstrable impact on patients, compared to a time-matched education program, with regard to additional self-reported secondary outcomes, including quality-of-recovery, pain catastrophizing, pain interference, depression, and anxiety.

Participants and recruitment:

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 (Participant, Outcomes Assessor)

盲法说明

Patients will be blinded to which intervention they will receive. The outcome assessors for this study will be unaware as to which group the participant will be randomised to and therefore they will be blinded to which intervention the participant had received

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Female patients
  • 18-75 years of age
  • Undergoing breast cancer surgery (wide local excision with magseed or full mastectomy)
  • Pain Catastrophizing Scale score of 24 of higher

排除标准

  • Pain Catastrophizing Scale score below 24
  • Surgery for benign breast disease
  • Patient non-consent
  • Plans to undergo major surgery within six months after current breast surgery
  • Comorbid severe psychiatric conditions such as schizophrenia or personality disorder
  • Known or suspected non-compliance
  • Known or suspected drug or alcohol abuse problems within past 3 months
  • Inability to follow the study procedures e.g. dementia or non-fluency of English
  • The presence of any serious medical comorbidity such as sepsis or cancer that might cause disability or worsen the patient's general health condition
  • Pregnancy
  • An opioid intrathecal pump
  • Prisoner within the criminal justice system
  • Cognitive behavioural therapy in the past 12 months

结局指标

主要结局

Brief Pain Inventory (BPI) Short-form: average pain severity

时间窗: 3 months post-operative

BPI Short-form is a 9 item questionnaire used to evaluate the severity of a patient's cancer or non cancer pain \[Tan G et al\]. Brief Pain Inventory short-form scale is measured between 0 - 10, where '0' indicates no pain and '10' indicates severe pain. A decrease in the Brief Pain Inventory score of 2 or more from the baseline score is considered significant and indicates an improvement in severity of the patient's cancer and non-cancer pain.

次要结局

  • Pain Catastrophizing Scale (PCS) Score(3 months post-operative)
  • Quality of Recovery-15 (QoR-15) Score(24 hours post-operative)
  • Brief Pain Inventory (BPI) Short-form: average interference score(3 months post-operative)
  • Hospital Anxiety and Depression Scale (HADS) Score(3 months post-operative)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Aneurin Moorthy

Research Fellow in Anaesthesia and Perioperative Medicine

Mater Misericordiae University Hospital

研究点 (2)

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