Well-Being After Breast Cancer Surgery (WB ABCs)
March 24, 2026 updated by: Duke University
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
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.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Actual)
316
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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North Carolina
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Durham, North Carolina, United States, 27705
- Duke University Medical Center
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15232
- University of Pittsburgh Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- prior diagnosis of Stage 0 to III breast cancer, DCIS or LCiS
- received first breast cancer surgery (total or partial mastectomy, lumpectomy) at least 3 months ago
- reports score of ≥3 in the past month on the 0 to 10 breast pain severity and/or interference scale
- able to speak and read English
- able to provide meaningful consent
Exclusion Criteria:
- <18 years of age
- hearing impairment that limits use of videoconferencing for intervention sessions
- cognitive impairment that is documented in the medical record or results in being unable to provide meaningful consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Coping Skills Training for Persistent Post-Surgical Pain
novel pain coping skills training intervention designed specifically for people with persistent pain (PP) following breast cancer surgery
|
skills training and experiential learning exercises
Other Names:
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|
Active Comparator: General health education with a coach
general health education intervention
|
general health education intervention that focuses on improving overall health
|
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Active Comparator: Self-guided health education
general health education intervention
|
general health education intervention that focuses on improving overall health
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in PEG Pain Severity and Interference
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)
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Baseline, 3 months, 6 months, 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in emotional distress: Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS)
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
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Baseline, 3 months, 6 months, 12 months
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Change in pain catastrophizing: Pain Catastrophizing Scale (PCS)
Time Frame: Baseline, 3 months, 6 months, 12 months
|
13-item assessment of the degree to which participants experience catastrophic thinking during painful experiences
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Baseline, 3 months, 6 months, 12 months
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Change in Central sensitization: Central Sensitization Inventory (CSI)
Time Frame: Baseline, 3 months, 6 months, 12 months
|
25-item questionnaire designed to measure hypersensitivity to senses and signs of central sensitization
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Baseline, 3 months, 6 months, 12 months
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Change in Central sensitization: Temporal summation
Time Frame: Baseline, 6 months, 12 months
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Designed to measure central pain mediation using weighted pinprick probes
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Baseline, 6 months, 12 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in cancer-specific distress: Impact of Event Scale (IES)
Time Frame: Baseline, 3 months, 6 months, 12 months
|
15-item measure of intrusive and avoidant cognition regarding breast cancer during the past week
|
Baseline, 3 months, 6 months, 12 months
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Change in psychological inflexibility: Acceptance and Action Questionnaire (AAQ-II)
Time Frame: Baseline, 3 months, 6 months, 12 months
|
7-item questionnaire designed to measure psychological inflexibility
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Baseline, 3 months, 6 months, 12 months
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Change in self-efficacy: Chronic Pain Self-Efficacy Scale: Function Self-Efficacy Subscale (FSE)
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
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Baseline, 3 months, 6 months, 12 months
|
|
Change in Pain sensitivity: Pressure pain thresholds
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
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Baseline, 6 months, 12 months
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Change in Pain sensitivity: Mechanical cutaneous pain thresholds
Time Frame: Baseline, 6 months, 12 months
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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.
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Baseline, 6 months, 12 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Dana Bovbjerg, PhD, University of Pittsburgh Medical Center
- Principal Investigator: Rebecca Shelby, PhD, Duke University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 8, 2021
Primary Completion (Actual)
March 11, 2026
Study Completion (Actual)
March 11, 2026
Study Registration Dates
First Submitted
January 3, 2020
First Submitted That Met QC Criteria
January 9, 2020
First Posted (Actual)
January 13, 2020
Study Record Updates
Last Update Posted (Actual)
March 27, 2026
Last Update Submitted That Met QC Criteria
March 24, 2026
Last Verified
February 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00104214
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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