Effect of Perioperative CBT on Chronic Persistent Postsurgical Pain Among Breast Cancer Patients

NCT04924010 | Completed

• 1 other identifier: CBTMMUH
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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

Breast Cancer; Chronic Pain; Chronic Postsurgical Pain; Quality of Life

Keywords

Breast Surgery; Chronic PostSurgical Pain (CPSP); Mastectomy; Wide Local Excision; Cognitive Behavioural Therapy (CBT); Psychological factors; Perioperative; Pain catastrophizing; Anxiety

Outcome Measures

Primary Outcomes (1)

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

  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.

  3 months post-operative

Secondary Outcomes (4)

• Quality of Recovery-15 (QoR-15) Score

  24 hours post-operative

• Pain Catastrophizing Scale (PCS) Score

  3 months post-operative

• Hospital Anxiety and Depression Scale (HADS) Score

  3 months post-operative

• Brief Pain Inventory (BPI) Short-form: average interference score

  3 months post-operative

Study Arms (2)

Cognitive Behavioural Therapy (CBT)

ACTIVE COMPARATOR

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.

Behavioral: Cognitive Behavioural Therapy (CBT)

Education and Mindfulness

PLACEBO COMPARATOR

Education and mindfulness therapy refers to lessons on techniques to calm the mind and body - can reduce the negative effects of stress

Behavioral: Education and Mindfulness

Interventions

Cognitive Behavioural Therapy (CBT) BEHAVIORAL

The CBT intervention will be delivered by a Senior Psychologist with seventeen years of hospital psychology experience, six in the treatment of chronic pain patients. Sessions are delivered in one hour, individual therapy appointments to patients, and there is an emphasis on relaxation training, cognitive restructuring, exercise and pacing, behavioral activation, improving sleep, and anger management. Standardized worksheets and homework assignments are an important part of CBT-CP and these will be given (post or email) to patients who will be asked to read and complete in terms of complementing the consultations. This intervention has been developed with reference to two sources: A successful national implementation of CBT for chronic pain (CBT-CP) using video teleconferencing format \[Connolly KS et al\] AND an evidence-based CBT manual specifically designed to treat chronic pain \[Murphy JL et al\].

Cognitive Behavioural Therapy (CBT)

Education and Mindfulness BEHAVIORAL

To control for differences in attention between the two interventions, patients in the mindfulness group will also have two meetings before the surgery and two meetings afterward. As the same person will be providing the CBT-CP and educational interventions, this confounding factor will be controlled for. The control intervention consists of discussing pain education, as derived from the self-management section of the chronic pain Ireland website (https://www.chronicpain.ie/our-services/self-management) and the persistent pain section of the pain toolkit website (https://www.paintoolkit.org/persistent-pain). Four mindfulness-based stress reduction exercises will be completed including an introductory session on mindful breathing, a guided meditation, progressive muscle relaxation, and a body scan. These sessions will last about half an hour.

Education and Mindfulness

Eligibility Criteria

• Age: 18 Years - 75 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mater Misericordiae University Hospital: lead

Study Sites (1)

Mater Misericordiae University Hospital

Dublin, D07 R2WY, Ireland

Location

Related Publications (21)

• Fletcher 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 BACKGROUND

• Kehlet 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 BACKGROUND

• Spivey 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 BACKGROUND

• Weiser 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 BACKGROUND

• Vranceanu 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 BACKGROUND

• Leung L. Pain catastrophizing: an updated review. Indian J Psychol Med. 2012 Jul;34(3):204-17. doi: 10.4103/0253-7176.106012.

  PMID: 23441031 BACKGROUND

• Wade 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.

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• Wideman TH, Sullivan MJ. Reducing catastrophic thinking associated with pain. Pain Manag. 2011 May;1(3):249-56. doi: 10.2217/pmt.11.14.

  PMID: 24646391 BACKGROUND

• Villa G, Lanini I, Amass T, Bocciero V, Scire Calabrisotto C, Chelazzi C, Romagnoli S, De Gaudio AR, Lauro Grotto R. Effects of psychological interventions on anxiety and pain in patients undergoing major elective abdominal surgery: a systematic review. Perioper Med (Lond). 2020 Dec 8;9(1):38. doi: 10.1186/s13741-020-00169-x.

  PMID: 33292558 BACKGROUND

• Giusti EM, Lacerenza M, Manzoni GM, Castelnuovo G. Psychological and psychosocial predictors of chronic postsurgical pain: a systematic review and meta-analysis. Pain. 2021 Jan;162(1):10-30. doi: 10.1097/j.pain.0000000000001999.

  PMID: 32694386 BACKGROUND

• Scott W, Wideman TH, Sullivan MJ. Clinically meaningful scores on pain catastrophizing before and after multidisciplinary rehabilitation: a prospective study of individuals with subacute pain after whiplash injury. Clin J Pain. 2014 Mar;30(3):183-90. doi: 10.1097/AJP.0b013e31828eee6c.

  PMID: 23552561 BACKGROUND

• Scarone P, Smeets AYJM, van Kuijk SMJ, van Santbrink H, Peters M, Koetsier E. A randomized controlled TRIal of cognitive BEhavioral therapy for high Catastrophizing in patients undergoing lumbar fusion surgery: the TRIBECA study. BMC Musculoskelet Disord. 2020 Dec 4;21(1):810. doi: 10.1186/s12891-020-03826-w.

  PMID: 33276768 BACKGROUND

• Tuna T, Boz S, Van Obbergh L, Lubansu A, Engelman E. Comparison of the Pain Sensitivity Questionnaire and the Pain Catastrophizing Scale in Predicting Postoperative Pain and Pain Chronicization After Spine Surgery. Clin Spine Surg. 2018 Nov;31(9):E432-E440. doi: 10.1097/BSD.0000000000000694.

  PMID: 30036209 BACKGROUND

• Chazapis M, Walker EM, Rooms MA, Kamming D, Moonesinghe SR. Measuring quality of recovery-15 after day case surgery. Br J Anaesth. 2016 Feb;116(2):241-8. doi: 10.1093/bja/aev413.

  PMID: 26787793 BACKGROUND

• Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.

  PMID: 6880820 BACKGROUND

• Wong K, Zeng L, Zhang L, Bedard G, Wong E, Tsao M, Barnes E, Danjoux C, Sahgal A, Holden L, Lauzon N, Chow E. Minimal clinically important differences in the brief pain inventory in patients with bone metastases. Support Care Cancer. 2013 Jul;21(7):1893-9. doi: 10.1007/s00520-013-1731-9. Epub 2013 Feb 15.

  PMID: 23411998 BACKGROUND

• Marcus J, Lasch K, Wan Y, Yang M, Hsu C, Merante D. An Assessment of Clinically Important Differences on the Worst Pain Severity Item of the Modified Brief Pain Inventory in Patients with Diabetic Peripheral Neuropathic Pain. Pain Res Manag. 2018 Jul 22;2018:2140420. doi: 10.1155/2018/2140420. eCollection 2018.

  PMID: 30140328 BACKGROUND

• Mease PJ, Spaeth M, Clauw DJ, Arnold LM, Bradley LA, Russell IJ, Kajdasz DK, Walker DJ, Chappell AS. Estimation of minimum clinically important difference for pain in fibromyalgia. Arthritis Care Res (Hoboken). 2011 Jun;63(6):821-6. doi: 10.1002/acr.20449.

  PMID: 21312349 BACKGROUND

• Burckhardt CS, Jones KD. Effects of chronic widespread pain on the health status and quality of life of women after breast cancer surgery. Health Qual Life Outcomes. 2005 Apr 28;3:30. doi: 10.1186/1477-7525-3-30.

  PMID: 15860132 BACKGROUND

• Moorthy A, Lowry D, Edgely C, Blajeva M, Casey MB, Buggy DJ. Perioperative cognitive behavioural therapy compared with pain education and mindfulness for chronic postsurgical pain in breast cancer patients with high pain catastrophising characteristics: a randomised, controlled, parallel group clinical trial. BJA Open. 2025 Oct 30;16:100499. doi: 10.1016/j.bjao.2025.100499. eCollection 2025 Dec.

  PMID: 41234748 DERIVED

• Moorthy A, Lowry D, Edgley C, Casey MB, Buggy D. Effect of perioperative cognitive behavioural therapy on chronic post-surgical pain among breast cancer patients with high pain catastrophising characteristics: protocol for a double-blinded randomised controlled trial. Trials. 2022 Jan 21;23(1):66. doi: 10.1186/s13063-022-06019-z.

  PMID: 35062997 DERIVED

Related Links

• Nationwide implementation and outcomes of cognitive behavioral therapy for chronic pain over clinical video teleconferencing. J Technol Behav Sci
• Cognitive behavioral therapy for chronic pain among veterans: therapist manual. Washington, DC: Department of Veterans Affairs
• Pain education, self-management section of the chronic pain Ireland

MeSH Terms

Conditions

Breast Neoplasms; Chronic Pain; Pain, Postoperative; Anxiety Disorders

Interventions

Cognitive Behavioral Therapy; Educational Status; Mindfulness

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; Postoperative Complications; Pathologic Processes; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Socioeconomic Factors; Population Characteristics

Study Officials

• Donal Buggy, MB Bch BAO

  Department of Anaesthesiology & Perioperative Medicine, Mater Misericordiae University Hospital,

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Fellow in Anaesthesia and Perioperative Medicine

Study Record Dates

• First Submitted: June 7, 2021
• First Posted: June 11, 2021
• Study Start: May 31, 2021
• Primary Completion: March 1, 2023
• Study Completion: March 2, 2023
• Last Updated: March 14, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 5 years
• Access Criteria: Publications, reports or query requests from future investigators.

Locations

IE (1)