Clinical trial · Interventional
Effect of Perioperative CBT on Chronic Persistent Postsurgical Pain Among Breast Cancer Patients
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Chronic Pain | — | UNRESOLVED | — |
| Chronic Postsurgical Pain | — | UNRESOLVED | — |
| Quality of Life | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cognitive Behavioural Therapy (CBT) | Behavioral | — | UNRESOLVED |
| Education and Mindfulness | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Cognitive Behavioural Therapy (CBT)
- description
- Cognitive behavioural therapy (CBT) is a talking therapy that can help patients manage problems by changing the way they think and behave. It's most commonly used to treat anxiety, depression and chronic pain conditions.
- interventionNames
- Behavioral: Cognitive Behavioural Therapy (CBT)
- type
- PLACEBO_COMPARATOR
- label
- Education and Mindfulness
- description
- Education and mindfulness therapy refers to lessons on techniques to calm the mind and body - can reduce the negative effects of stress
- interventionNames
- Behavioral: Education and Mindfulness
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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
References
Publications (21)
- BACKGROUNDFletcher D, Stamer UM, Pogatzki-Zahn E, Zaslansky R, Tanase NV, Perruchoud C, Kranke P, Komann M, Lehman T, Meissner W; euCPSP group for the Clinical Trial Network group of the European Society of Anaesthesiology. Chronic postsurgical pain in Europe: An observational study. Eur J Anaesthesiol. 2015 Oct;32(10):725-34. doi: 10.1097/EJA.0000000000000319. PMID 26241763
- BACKGROUNDKehlet H, Jensen TS, Woolf CJ. Persistent postsurgical pain: risk factors and prevention. Lancet. 2006 May 13;367(9522):1618-25. doi: 10.1016/S0140-6736(06)68700-X. PMID 16698416
- BACKGROUNDSpivey TL, Gutowski ED, Zinboonyahgoon N, King TA, Dominici L, Edwards RR, Golshan M, Schreiber KL. Chronic Pain After Breast Surgery: A Prospective, Observational Study. Ann Surg Oncol. 2018 Oct;25(10):2917-2924. doi: 10.1245/s10434-018-6644-x. Epub 2018 Jul 16. PMID 30014456
- BACKGROUNDWeiser TG, Regenbogen SE, Thompson KD, Haynes AB, Lipsitz SR, Berry WR, Gawande AA. An estimation of the global volume of surgery: a modelling strategy based on available data. Lancet. 2008 Jul 12;372(9633):139-144. doi: 10.1016/S0140-6736(08)60878-8. Epub 2008 Jun 24. PMID 18582931
- BACKGROUNDVranceanu AM, Bachoura A, Weening A, Vrahas M, Smith RM, Ring D. Psychological factors predict disability and pain intensity after skeletal trauma. J Bone Joint Surg Am. 2014 Feb 5;96(3):e20. doi: 10.2106/JBJS.L.00479. PMID 24500592
- BACKGROUNDLeung L. Pain catastrophizing: an updated review. Indian J Psychol Med. 2012 Jul;34(3):204-17. doi: 10.4103/0253-7176.106012. PMID 23441031
- BACKGROUNDWade JB, Riddle DL, Thacker LR. Is pain catastrophizing a stable trait or dynamic state in patients scheduled for knee arthroplasty? Clin J Pain. 2012 Feb;28(2):122-8. doi: 10.1097/AJP.0b013e318226c3e2.