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Principal Investigator: DANA H. BOVBJERG
Organization: DUKE UNIVERSITY
Fiscal Year: 2024
Award: $590,996
Funding agency: National Cancer Institute
Abstract
Persistent pain following breast cancer surgery 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 cancer
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
(Targeted PCST) and aims to reduce pain catastrophizing, increase self-efficacy for engaging in valued
activities, and decrease psychological inflexibility. We propose a multiple-site, randomized clinical trial to
evaluate the efficacy of the Targeted-PCST intervention. The study will be conducted in 9 diverse oncology
clinics: 5 affiliated with Duke University/Duke Cancer Network and 4 affiliated with the University of
Pittsburgh/UPMC Hillman Cancer Center. Participants (N=564) will be randomized to either receive: 1)
Targeted-PCST, 2) a general health education intervention (control), or 3) usual care (control). Participants will
complete assessments pre-intervention and at 3 months (post-intervention), 6 months follow-up, and 12
months follow-up. Study aims are: Aim1: Examine the impact of Targeted-PCST 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 Targeted-PCST on pain catastrophizing, pain self-efficacy,
and psychological inflexibility, and evaluate these variables as possible mediators of the benefits of Targeted-
PCST. Aim 3: Evaluate the impact of Targeted-PCST on pain sensitivity and central sensitization, and explore
whether changes in these variables mediate group differences in pain severity and interference.
Terms: <Abscission><Active Follow-up><Acute><Address><Adoption><Affect><Anxiety><Automobile Driving><Award><Breast><Breast Cancer><Breast Cancer Patient><Breast Cancer survivor><Breast Tumor Patient><Cancer Center><Cancers><Causality><Clinic><Clinical><Clinical Trials Design><Coping Skills><Distress><Education for Intervention><Educational Intervention><Etiology><Excision><Extirpation><Financial cost><Health Instruction><Health Tutoring><Health education><Institution><Instruction Intervention><Intervention><Intervention Strategies><Limited Resection Mastectomy><Local Excision Mastectomy><Lumpectomy><Malignant Breast Neoplasm><Malignant Neoplasms><Malignant Tumor><Mammectomy><Manuals><Mastectomy><Mediating><Mediator><Mental Depression><Newly Diagnosed><Non-pharmacologic Therapy><Nonpharmacologic Intervention><Nonpharmacologic Therapy><Nonpharmacologic approach><Nonpharmacologic treatment><Oncology><Oncology Cancer><Operative Procedures><Operative Surgical Procedures><Pain><Pain interference><Painful><Participant><Patients><Persistent pain><Pharmacological Treatment><Physical Function><Post-operative Pain><Postoperative Pain><Prevalence><Process><Psychosocial Factor><Public Health><QOL><Quality of life><Randomized><Removal><Research><Role><Self Efficacy><Sensory><Severities><Site><Surgical><Surgical Interventions><Surgical Procedure><Surgical Removal><Survivors><Testing><Training Intervention><Trauma><Universities><Woman><active followup><breast lumpectomy><cancer surgery><care as usual><causation><central sensitization><clinical significance><clinically significant><constant pain><coping strategy><curative intervention><curative therapeutic><curative therapy><curative treatments><depression><design><designing><determine efficacy><disease causation><driving><effective intervention><efficacy analysis><efficacy assessment><efficacy determination><efficacy evaluation><efficacy examination><emotional distress><emotional functioning><evaluate efficacy><examine efficacy><experience><feeling distress><feeling upset><follow up><follow-up><followed up><followup><improved><instructional intervention><intervention cost><interventional strategy><lasting pain><malignancy><malignant breast tumor><monetary cost><neoplasm/cancer><non-drug therapy><non-drug treatment><nondrug therapy><nondrug treatment><novel><on-going pain><ongoing pain><pain after surgery><pain catastrophizing><pain reduction><pain sensitivity><pilot test><post intervention><post-surgical pain><postsurgical pain><primary outcome><psychobiologic><psychobiological><psychologic><psychological><psychosocial variables><randomisation><randomization><randomized, clinical trials><randomly assigned><reduce pain><resection><response><secondary outcome><skills training><social role><surgery><treatment as usual><usual care>