Well-Being After Breast Cancer Surgery: Targeted-PCST for Persistent Post-Mastectomy Pain
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ClinicalTrials.gov Identifier: NCT04225585 |
Recruitment Status :
Recruiting
First Posted : January 13, 2020
Last Update Posted : June 24, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Targeted Pain Coping Skills Training General Health Education Enhanced Usual Care | Behavioral: Targeted-PCST 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: | Persistent Post-Mastectomy Pain: Randomized Clinical Trial of Targeted Pain Coping Skills Training (Targeted-PCST) With Mediational Analysis |
Actual Study Start Date : | June 8, 2021 |
Estimated Primary Completion Date : | April 2025 |
Estimated Study Completion Date : | April 2025 |

Arm | Intervention/treatment |
---|---|
Experimental: Targeted Pain Coping Skills Training (Targeted-PCST)
novel pain coping skills training intervention designed specifically for women with persistent pain (PP) following breast cancer surgery (active intervention group)
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Behavioral: Targeted-PCST
skills training and experiential learning exercises
Other Name: Targeted Pain Coping Skills Training |
Placebo Comparator: General health education
general health education Intervention (control group)
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Behavioral: General health education
general health education intervention that focuses on improving overall health |
No Intervention: Self-guided health education
usual health care and usual medical treatment for pain
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- 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: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- prior diagnosis of Stage 0 to III breast cancer
- received first breast cancer surgery (total or partial mastectomy, lumpectomy) in the past 3 to 12 months
- reports average breast pain of ≥3 in the past month on the 0 to 10 pain severity scale
- able to speak and read English
- able to provide meaningful consent
Exclusion Criteria:
- <18 years of age
- history of prior breast surgery
- 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 | Not yet 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: | June 24, 2021 |
Last Verified: | June 2021 |
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 |