CST-PSP
Behavioralskills training and experiential learning exercises
Other names: Coping Skills Training for Persistent Post-Surgical Pain
NCT Number: NCT04225585
The purpose of this study is to compare the benefits of skills training and health education interventions designed specifically to increase the well-being of people with persistent pain after breast surgery for lobular carcinoma in situ (LCIS), ductal carcinoma in situ (DCIS), or invasive breast cancer, and to examine the roles of psychological and physiological variables as modifiable contributors to the continuing burden of persistent pain.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Duke University Medical Center, Durham, North Carolina, United States
Persistent pain following breast surgery for lobular carcinoma in situ (LCIS), ductal carcinoma in situ (DCIS), or invasive breast cancer is increasingly recognized as an important clinical and public health issue due to the large number of women affected, the powerful negative impact that persistent pain has on emotional and physical functioning and its financial costs. Most of the more than a quarter of a million women newly diagnosed with breast cancer in the U.S. this year will undergo surgery as a part of curative treatment. The prevalence of persistent pain following surgical removal of the affected breast (mastectomy) or more limited surgeries (lumpectomy) is high, ranging from 25-60% across studies. Unlike acute post-operative pain, which is a normal response to surgical trauma, persistent pain at or near the surgical site has an uncertain multifaceted etiology, and no satisfactory pharmacological treatment. A critical question is whether key pain-related psychosocial factors are drivers of the continuing burden of persistent pain, and whether they could be ameliorated by non-pharmacological intervention. The research planned under this award will provide a first critical test of the hypothesized driving role of pain catastrophizing in persistent pain after breast surgery. It also will explore the role of two other key psychosocial variables that may contribute to the burden associated with persistent pain after breast cancer surgery: self-efficacy for engaging in valued activities and psychological inflexibility. We have developed, manualized, and pilot tested a pain coping skills training intervention that specifically targets the needs of women with persistent pain following breast cancer surgery (CST-PSP) and aims to reduce pain catastrophizing, increase self-efficacy for engaging in valued activities, and increase psychological flexibility. We propose a multiple-site, randomized clinical trial to evaluate the efficacy of the CST-PSP intervention, as well as a health education intervention. The study will be conducted in diverse oncology clinics affiliated with Duke University/Duke Cancer Network and the University of Pittsburgh/UPMC Hillman Cancer Center. Participants (N=316) will be randomized to either receive: 1) CST-PSP, 2) health education with an interventionist, or 3) self-guided health education . Participants will complete assessments pre-intervention and at 3 months (post-intervention), 6 months follow-up, and 12 months follow-up. Study aims are: Aim 1: Examine the impact of intervention programs on persistent post-surgical pain severity and interference (i.e., PEG score), emotional distress (anxiety and depression), and cancer-specific distress. Aim 2: Investigate the impact of intervention programs on pain catastrophizing, pain self-efficacy, and psychological inflexibility, and evaluate these variables as possible mediators of the intervention benefits. Aim 3: Evaluate the impact of intervention programs on pain sensitivity and central sensitization, and explore whether changes in these variables mediate group differences in pain severity and interference.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
skills training and experiential learning exercises
Other names: Coping Skills Training for Persistent Post-Surgical Pain
general health education intervention that focuses on improving overall health
Time frame: Baseline, 3 months, 6 months, 12 months
Persistent post-surgical pain burden 3-item measure: average pain intensity (P); interference with enjoyment in life (E); interference with general activity (G)
Time frame: Baseline, 3 months, 6 months, 12 months
Composite score of 8-item assessment of depressive symptoms over the past two weeks and 7-item assessment of symptoms of anxiety over the past two weeks
Time frame: Baseline, 3 months, 6 months, 12 months
13-item assessment of the degree to which participants experience catastrophic thinking during painful experiences
Time frame: Baseline, 3 months, 6 months, 12 months
25-item questionnaire designed to measure hypersensitivity to senses and signs of central sensitization
Time frame: Baseline, 6 months, 12 months
Designed to measure central pain mediation using weighted pinprick probes
Time frame: Baseline, 3 months, 6 months, 12 months
15-item measure of intrusive and avoidant cognition regarding breast cancer during the past week
Time frame: Baseline, 3 months, 6 months, 12 months
7-item questionnaire designed to measure psychological inflexibility
Time frame: Baseline, 3 months, 6 months, 12 months
9-item questionnaire designed to measure chronic pain patients' perceived self-efficacy for engaging in activities
Time frame: Baseline, 6 months, 12 months
Designed to measure central hyperexcitability using a digital pressure algometer measured pressure that is first perceived as painful and recorded in kg
Time frame: Baseline, 6 months, 12 months
Assessed using weighted pinprick probes with standard stimulus intensities (8, 16, 32, 64, 128, 256, and 512 mN) and contact areas (tip diameter 0.20 mm). Stimuli are applied to the middle phalanx of digit 3, beginning with the lowest-force stimulator until the suprathreshold value is reached. The direction of the testing is then changed toward lower stimulus intensities until the probe stimulation is perceived as 'touch' only (sub-threshold value). Testing then directs again toward higher intensities, until 5 suprathreshold and 5 subthreshold values have been recorded.
Duke University
Other
Improving Well-Being for Individuals With Persistent Pain After Surgery for Breast Cancer, Lobular Carcinoma in Situ, or Ductal Carcinoma in Situ: A Randomized Clinical Trial That Compares Three Behavioral Intervention Strategies and Examines Psychological Factors as Drivers of the Continuing Burden of Persistent Pain
Acronym: WB ABCs
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