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

CompletedNot applicableNCT04924010
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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 studie…

Study details

Official title
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
Interventions
  • Behavioral: Cognitive Behavioural Therapy (CBT)
  • Behavioral: Education and Mindfulness
Sponsor
Mater Misericordiae University Hospital
Start date
2021-05-31
Primary completion
2023-03-01
Sex
Female
Age range
from 18 Years to 75 Years
Results posted
No results posted in this snapshot
Countries
Ireland
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
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

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04924010