Ignite Creation Date:
2024-05-06 @ 4:14 PM
Last Modification Date:
2024-10-26 @ 2:06 PM
Study NCT ID:
NCT04924010
Status:
COMPLETED
Last Update Posted:
2023-03-14
First Post:
2021-06-07
Brief Title:
Effect of Perioperative CBT on Chronic Persistent Postsurgical Pain Among Breast Cancer Patients
Sponsor:
Mater Misericordiae University Hospital
Organization:
Mater Misericordiae University Hospital
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
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 eg 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
Adult patients who are undergoing breast surgery defined as wide excision with magseed surgery or full mastectomy patients with or without axillary clearance who are proficient in the English language will be eligible for inclusion Patients will be enrolled at the outpatient clinic of the Department of Anaesthesiology and the Breast Health Department at the Mater Misericordiae University Hospital All patients entering the screening phase of the study will be registered on a Study Patient Registration Log and a unique registration number will be assigned Clinical data will be assessed to evaluate a subjects eligibility
Patients eligible for participation will be evaluated approximately two weeks before surgery and asked for informed consent and then asked to complete the Pain Catastrophizing Scale PCS Sullivan M et al by a member of the research team Patients with high pain catastrophizing defined as a score of 24 on the PCS will be eligible for randomization to perioperative treatment with CBT or the education and mindfulness program This cut-off is based on a previous study that showed a pre-treatment score of 24 or higher on the PCS best-predicted follow-up chronic pain ratings and work status after multidisciplinary treatmentScott W et al and has since been selected as an appropriate score cut-off in a perioperative CBT intervention in lumbar surgery patients Scarone P et al More recently this cut-off was also suggested to obtain the highest sensitivity and specificity to predict unfavorable outcomes after spinal surgery Tuna T et al
Randomization
Patients will be randomized after they are included in the study having consented and completed the PCS and scoring scored 24 and two preoperative appointments will be scheduled with the patients in the intervention and control groups Patients will be randomized to either CBT or Education group by using an online computer-generated block randomization The patient study number and group allocation will be typed onto separate pages and concealed in sequentially numbered sealed envelopes Block randomization will occur as follows 12 subjects per block to ensure even numbers of participants in each arm of the study and the number of blocks that will be used is 4 Randomization will be performed by an independent third party The randomization keyseed will also be held by an independent third party and investigators will not have access to this keyseed until the study has been completed
The envelope will be opened by the treating psychologist to reveal the group allocation Patients and members of the research team involved in data collection and analyzing the data will be masked to group allocation The treating psychologist will not be blinded Group allocations will be revealed immediately if there was a clinical concern
All patients in both interventional arms
All patients irrespective of group allocation will be routinely prescribed medications for pain control and will be referred for physical therapy on an out-patient basis or other services depending on clinical indications and personal needs
Sample size power considerations and statistical analysis
The primary outcome is the difference in the BPI average pain severity score and average pain interference score between the study groups three months after surgery A clinically important difference on the BPI is a 2 raw score reduction on the 11-point NRS Wong K et al Marcus J et al Mease PJ etl al The standard deviation SD of BPI scores after breast surgery is in the order of 23 on this scale Burckhardt CS et al Taking a BPI score reduction of 2 as being clinically significant then n21 patients would be required each arm if Type I error005 and Type II error is 02 power 80 Taking into account a 10 drop-outs rate we propose to enroll 24 eligible patients in each group N48 total
Baseline patient characteristics will be stratified by group and presented as mean and standard deviation SD median and first and third quartile and count and percentage as appropriate Differences in baseline characteristics between randomized groups will not be statistically tested whereas differences with the separate control cohort will be tested using the independent-samples t-test for continuous variables and Pearsons chi-square test for categorical variables In case of expected cell counts of less than 5 Fishers Exact test will be used instead
All patients randomized ie those with a PCS score 24 will be analyzed in an intention-to-treat analysis To test for a difference between the CBT and control group in the BPI average pain intensity scale at three months linear regression will be used Adjustment for the type of surgery age and education will be made and if necessary for other prognostic variables significantly associated with the outcome ie acute postoperative pain intensity the severity of catastrophizing preoperative depression preoperative surgical fear length of current sick leave pain duration
Secondary outcome variables will be analyzed similarly to the primary outcome For these logistic regression analysis will be used to test for differences in proportions at three months postoperatively For exploratory purposes we will compare the outcomes of the patients in the two intervention groups with the outcomes of patients with low pain catastrophizing scores ie those with a PCS score 24 undergoing care as usual Linear mixed-effects regression for the three groups will be performed with primary and secondary outcomes at the three postoperative assessment periods and controlling for preoperative values This analysis will indicate whether high catastrophizing patients follow a similar trajectory of pain and functioning after breast surgery compared to non-catastrophizing patients
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
Adult patients who are undergoing breast surgery defined as wide excision with magseed surgery or full mastectomy patients with or without axillary clearance who are proficient in the English language will be eligible for inclusion Patients will be enrolled at the outpatient clinic of the Department of Anaesthesiology and the Breast Health Department at the Mater Misericordiae University Hospital All patients entering the screening phase of the study will be registered on a Study Patient Registration Log and a unique registration number will be assigned Clinical data will be assessed to evaluate a subjects eligibility
Patients eligible for participation will be evaluated approximately two weeks before surgery and asked for informed consent and then asked to complete the Pain Catastrophizing Scale PCS Sullivan M et al by a member of the research team Patients with high pain catastrophizing defined as a score of 24 on the PCS will be eligible for randomization to perioperative treatment with CBT or the education and mindfulness program This cut-off is based on a previous study that showed a pre-treatment score of 24 or higher on the PCS best-predicted follow-up chronic pain ratings and work status after multidisciplinary treatmentScott W et al and has since been selected as an appropriate score cut-off in a perioperative CBT intervention in lumbar surgery patients Scarone P et al More recently this cut-off was also suggested to obtain the highest sensitivity and specificity to predict unfavorable outcomes after spinal surgery Tuna T et al
Randomization
Patients will be randomized after they are included in the study having consented and completed the PCS and scoring scored 24 and two preoperative appointments will be scheduled with the patients in the intervention and control groups Patients will be randomized to either CBT or Education group by using an online computer-generated block randomization The patient study number and group allocation will be typed onto separate pages and concealed in sequentially numbered sealed envelopes Block randomization will occur as follows 12 subjects per block to ensure even numbers of participants in each arm of the study and the number of blocks that will be used is 4 Randomization will be performed by an independent third party The randomization keyseed will also be held by an independent third party and investigators will not have access to this keyseed until the study has been completed
The envelope will be opened by the treating psychologist to reveal the group allocation Patients and members of the research team involved in data collection and analyzing the data will be masked to group allocation The treating psychologist will not be blinded Group allocations will be revealed immediately if there was a clinical concern
All patients in both interventional arms
All patients irrespective of group allocation will be routinely prescribed medications for pain control and will be referred for physical therapy on an out-patient basis or other services depending on clinical indications and personal needs
Sample size power considerations and statistical analysis
The primary outcome is the difference in the BPI average pain severity score and average pain interference score between the study groups three months after surgery A clinically important difference on the BPI is a 2 raw score reduction on the 11-point NRS Wong K et al Marcus J et al Mease PJ etl al The standard deviation SD of BPI scores after breast surgery is in the order of 23 on this scale Burckhardt CS et al Taking a BPI score reduction of 2 as being clinically significant then n21 patients would be required each arm if Type I error005 and Type II error is 02 power 80 Taking into account a 10 drop-outs rate we propose to enroll 24 eligible patients in each group N48 total
Baseline patient characteristics will be stratified by group and presented as mean and standard deviation SD median and first and third quartile and count and percentage as appropriate Differences in baseline characteristics between randomized groups will not be statistically tested whereas differences with the separate control cohort will be tested using the independent-samples t-test for continuous variables and Pearsons chi-square test for categorical variables In case of expected cell counts of less than 5 Fishers Exact test will be used instead
All patients randomized ie those with a PCS score 24 will be analyzed in an intention-to-treat analysis To test for a difference between the CBT and control group in the BPI average pain intensity scale at three months linear regression will be used Adjustment for the type of surgery age and education will be made and if necessary for other prognostic variables significantly associated with the outcome ie acute postoperative pain intensity the severity of catastrophizing preoperative depression preoperative surgical fear length of current sick leave pain duration
Secondary outcome variables will be analyzed similarly to the primary outcome For these logistic regression analysis will be used to test for differences in proportions at three months postoperatively For exploratory purposes we will compare the outcomes of the patients in the two intervention groups with the outcomes of patients with low pain catastrophizing scores ie those with a PCS score 24 undergoing care as usual Linear mixed-effects regression for the three groups will be performed with primary and secondary outcomes at the three postoperative assessment periods and controlling for preoperative values This analysis will indicate whether high catastrophizing patients follow a similar trajectory of pain and functioning after breast surgery compared to non-catastrophizing patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None