Well-Being After Breast Cancer Surgery (WB ABCs)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04225585 |
Recruitment Status :
Recruiting
First Posted : January 13, 2020
Last Update Posted : February 9, 2023
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Condition or disease | Intervention/treatment | Phase |
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Coping Skills Training for Persistent Post-Surgical Pain General Health Education | Behavioral: CST-PSP Behavioral: General health education | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 564 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Masking Description: | Study staff conducting assessments will be blind to group assignment. To maintain blinding, we will use the following approaches: 1) all study staff will be trained on the importance of blinding and study procedures to maintain blinding; 2) participants will be provided with the rationale and instructions not to disclose their group assignment; 3) the study staff who conduct post-intervention assessments will not be given information about group assignment prior to the assessment; and 4) if a breach occurs, it will be documented and the participant will complete their assessment with a new assessor. |
Primary Purpose: | Treatment |
Official Title: | 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 |
Actual Study Start Date : | June 8, 2021 |
Estimated Primary Completion Date : | April 30, 2025 |
Estimated Study Completion Date : | April 30, 2025 |

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
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Behavioral: CST-PSP
skills training and experiential learning exercises
Other Name: Coping Skills Training for Persistent Post-Surgical Pain |
Active Comparator: General health education with a coach
general health education intervention
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Behavioral: General health education
general health education intervention that focuses on improving overall health |
Active Comparator: Self-guided health education
general health education intervention
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Behavioral: General health education
general health education intervention that focuses on improving overall health |
- 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)
- Patient Health Questionnaire Depression Screener (PHQ-9) [ Time Frame: Baseline, 3 months, 6 months, 12 months ]9-item assessment of depressive symptoms over the past two weeks
- 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
- 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
- Acceptance and Action Questionnaire (AAQ-II) [ Time Frame: Baseline, 3 months, 6 months, 12 months ]7-item questionnaire designed to measure psychological inflexibility
- 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
- 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
- Central sensitization: Temporal summation [ Time Frame: Baseline, 6 months, 12 months ]Designed to measure central pain mediation using weighted pinprick probes
- Generalized Anxiety Disorder Screener (GAD-7) [ Time Frame: Baseline, 3 months, 6 months, 12 months ]7-item assessment of symptoms of anxiety over the past two weeks
- 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
- Patient Healthcare Utilization [ Time Frame: Baseline, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 9 months, 12 months ]6-item self-report of time spent utilizing healthcare in the past 4 weeks, as well as medication use and time spent on the intervention
- Five-level EuroQoL-5 Dimensions (5L EQ-5D) [ Time Frame: Baseline, 3 months, 6 months, 12 months ]5-item assessment of current health utility, plus 0 to 100 rating of overall health; QALYS will be derived from utility estimates

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04225585
Contact: Rebecca Shelby, PhD | 919-416-3410 | rebecca.shelby@duke.edu | |
Contact: Dana Bovbjerg, PhD | 412-623-5965 | bovbjergdh@upmc.edu |
United States, North Carolina | |
Duke University Medical Center | Recruiting |
Durham, North Carolina, United States, 27705 | |
Contact: Rebecca Shelby, PhD 919-416-3410 rebecca.shelby@duke.edu | |
Principal Investigator: Rebecca Shelby, PhD | |
United States, Pennsylvania | |
University of Pittsburgh Medical Center | Recruiting |
Pittsburgh, Pennsylvania, United States, 15232 | |
Contact: Dana Bovbjerg, PhD 412-623-5965 bovbjergdh@upmc.edu | |
Principal Investigator: Dana Bovbjerg, PhD |
Principal Investigator: | Rebecca Shelby, PhD | Duke University | |
Principal Investigator: | Dana Bovbjerg, PhD | University of Pittsburgh Medical Center |
Responsible Party: | Duke University |
ClinicalTrials.gov Identifier: | NCT04225585 |
Other Study ID Numbers: |
Pro00104214 |
First Posted: | January 13, 2020 Key Record Dates |
Last Update Posted: | February 9, 2023 |
Last Verified: | February 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Pain, Postoperative Postoperative Complications Pathologic Processes Pain Neurologic Manifestations |