Ignite Creation Date:
2024-05-06 @ 4:01 AM
Last Modification Date:
2024-10-26 @ 11:42 AM
Study NCT ID:
NCT02439437
Status:
COMPLETED
Last Update Posted:
2020-05-01
First Post:
2015-03-06
Brief Title:
Targeted Pain Coping Skills Training PCST for Prevention and Treatment of Persistent Post-Mastectomy Pain
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
Targeted Pain Coping Skills Training PCST for Prevention and Treatment of Persistent Post-Mastectomy Pain
Status:
COMPLETED
Status Verified Date:
2019-11
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:
This study looks at whether a coping skills training program can help women manage pain and stress after breast surgery and lower the risk of developing chronic pain This coping skills program includes eight training sessions that are done by telephone These sessions will focus on strategies for dealing with pain and stress and how to apply these strategies to subjects own experiences
Detailed Description:
Persistent pain following breast cancer surgery is increasingly being recognized as an important clinical and public health issue due to the large numbers of women affected the negative impact that persistent pain has on emotional and physical functioning and its financial cost Most of the 230000 women that are expected to be newly diagnosed with breast cancer in the US this year will undergo surgical treatment Surgical removal of the affected breast mastectomy or excision of the tumor lumpectomy followed by radiation markedly reduces the risk of disease progression and mortality However women undergoing even the more limited lumpectomy are at substantial risk for persistent pain Estimates of pains prevalence range from 25-60 across multiple studies with rates differing based on the stringency of the definition of persistent pain In one recent study 325 of the women who had undergone breast cancer surgery reported clinically significant persistent pain defined as a 310-pain severity rating for the breast axilla side or arm
Unlike acute post-operative pain which is considered to be a normal response to surgical trauma persistent pain has little biological utility and has proven difficult to treat once established A critical question is whether there are modifiable factors that contribute to the risk of developing persistent pain following breast cancer surgery that could be targeted for early preventative intervention To date attempts to reduce the risk of persistent pain have focused on alterations in medicalsurgical procedures these studies have had mixed results consistent with mixed findings in the broader literature regarding the status of medicalsurgical variables as risk factors for persistent pain In contrast there have been multiple studies showing associations between pain catastrophizing depression and anxiety and persistent pain In these studies pain catastrophizing shows the strongest and most consistent relationship to persistent pain as evidenced in a recent meta-analysis Consistent with the biopsychosocial theory of pain there is also evidence from quantitative sensory testing QST studies that alterations in central pain modulation pathways contribute to the development of post-surgical persistent pain including recent studies with breast cancer patients Since pain catastrophizing has been found to be associated with pernicious alterations in central pain modulation intervening to reduce catastrophizing may be a particularly effective prevention strategy for persistent pain following breast cancer surgery Pain coping skills training PCST interventions based on cognitive-behavioral principles are the only interventions demonstrated to reduce catastrophizing alter central modulation of pain and reduce chronic pain
The overarching hypothesis for the proposed pilot study N60 is that a targeted PCST protocol specifically designed for women at risk for persistent pain following breast cancer surgery pain score of 3 or greater 0-10 scale during the first 9 months post-surgery will significantly reduce this devastating consequence of treatment compared to usual care with printed education materials
Aim 1 To use a pilot RCT N60 to examine the feasibility acceptability and engagement in the targeted PCST protocol Feasibility will be assessed by examining overall accrual attrition and adherence to the study protocol engagement will be assessed by the use of intervention sessions and questionnaires number completed and acceptability will be assessed with a standardized measure of satisfaction
Aim 2 To obtain an estimate of the effect size of the targeted PCST protocol for persistent post-surgical pain in comparison to the usual care condition Effect sizes for group differences on pain burden symptoms of anxiety and depression breast cancer specific distress perceived stress sleep interference with daily activities pain catastrophizing and hypothesized changes in peripheral sensitivity and central inhibition will also be computed
The proposed study represents the next critical step in research examining persistent pain after surgical treatment for breast cancer The proposed study will provide the necessary preliminary data for larger studies aimed at testing the targeted PCST intervention This study will also provide preliminary data for future studies focused on pain sensitivity and central pain modulation in breast cancer survivors
Unlike acute post-operative pain which is considered to be a normal response to surgical trauma persistent pain has little biological utility and has proven difficult to treat once established A critical question is whether there are modifiable factors that contribute to the risk of developing persistent pain following breast cancer surgery that could be targeted for early preventative intervention To date attempts to reduce the risk of persistent pain have focused on alterations in medicalsurgical procedures these studies have had mixed results consistent with mixed findings in the broader literature regarding the status of medicalsurgical variables as risk factors for persistent pain In contrast there have been multiple studies showing associations between pain catastrophizing depression and anxiety and persistent pain In these studies pain catastrophizing shows the strongest and most consistent relationship to persistent pain as evidenced in a recent meta-analysis Consistent with the biopsychosocial theory of pain there is also evidence from quantitative sensory testing QST studies that alterations in central pain modulation pathways contribute to the development of post-surgical persistent pain including recent studies with breast cancer patients Since pain catastrophizing has been found to be associated with pernicious alterations in central pain modulation intervening to reduce catastrophizing may be a particularly effective prevention strategy for persistent pain following breast cancer surgery Pain coping skills training PCST interventions based on cognitive-behavioral principles are the only interventions demonstrated to reduce catastrophizing alter central modulation of pain and reduce chronic pain
The overarching hypothesis for the proposed pilot study N60 is that a targeted PCST protocol specifically designed for women at risk for persistent pain following breast cancer surgery pain score of 3 or greater 0-10 scale during the first 9 months post-surgery will significantly reduce this devastating consequence of treatment compared to usual care with printed education materials
Aim 1 To use a pilot RCT N60 to examine the feasibility acceptability and engagement in the targeted PCST protocol Feasibility will be assessed by examining overall accrual attrition and adherence to the study protocol engagement will be assessed by the use of intervention sessions and questionnaires number completed and acceptability will be assessed with a standardized measure of satisfaction
Aim 2 To obtain an estimate of the effect size of the targeted PCST protocol for persistent post-surgical pain in comparison to the usual care condition Effect sizes for group differences on pain burden symptoms of anxiety and depression breast cancer specific distress perceived stress sleep interference with daily activities pain catastrophizing and hypothesized changes in peripheral sensitivity and central inhibition will also be computed
The proposed study represents the next critical step in research examining persistent pain after surgical treatment for breast cancer The proposed study will provide the necessary preliminary data for larger studies aimed at testing the targeted PCST intervention This study will also provide preliminary data for future studies focused on pain sensitivity and central pain modulation in breast cancer survivors
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None