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

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

Interventions

BEHAVIORAL

Cognitive Behavioural Therapy (CBT)

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 \[Murphy JL et al\].

BEHAVIORAL

Education and Mindfulness

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.

Sponsors & Collaborators

• Mater Misericordiae University Hospital

  lead OTHER

Principal Investigators

• Donal Buggy, MB Bch BAO · Department of Anaesthesiology & Perioperative Medicine, Mater Misericordiae University Hospital,

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-05-31

Primary Completion

2023-03-01

Completion

2023-03-02

Countries

• Ireland

Study Locations