Well-Being After Breast Cancer Surgery (WB ABCs)

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: Recruiting
• Conditions: General Health Education; Coping Skills Training for Persistent Post-Surgical Pain
• Intervention / Treatment: Behavioral: CST-PSP; Behavioral: General health education

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=564) 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 (Estimated): 307
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rebecca Shelby, PhD; Phone Number: 919-416-3410; Email: rebecca.shelby@duke.edu
• Study Contact Backup: Name: Dana Bovbjerg, PhD; Phone Number: 412-623-5965; Email: bovbjergdh@upmc.edu

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Recruiting
      • Duke University Medical Center
      • Contact: Rebecca Shelby, PhD; Phone Number: 919-416-3410; Email: rebecca.shelby@duke.edu
      • Principal Investigator: Rebecca Shelby, PhD
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15232
      • Recruiting
      • University of Pittsburgh Medical Center
      • Contact: Dana Bovbjerg, PhD; Phone Number: 412-623-5965; Email: bovbjergdh@upmc.edu
      • Principal Investigator: Dana Bovbjerg, PhD

Participation Criteria

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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

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	Behavioral: CST-PSP; skills training and experiential learning exercises; Other Names: Coping Skills Training for Persistent Post-Surgical Pain
Active Comparator: General health education with a coach; general health education intervention	Behavioral: General health education; general health education intervention that focuses on improving overall health
Active Comparator: Self-guided health education; general health education intervention	Behavioral: General health education; 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	Persistent post-surgical pain burden 3-item measure: average pain intensity (P); interference with enjoyment in life (E); interference with general activity (G)	Baseline, 3 months, 6 months, 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Health Questionnaire Depression Screener (PHQ-9)	9-item assessment of depressive symptoms over the past two weeks	Baseline, 3 months, 6 months, 12 months
Impact of Event Scale (IES)	15-item measure of intrusive and avoidant cognition regarding breast cancer during the past week	Baseline, 3 months, 6 months, 12 months
Pain Catastrophizing Scale (PCS)	13-item assessment of the degree to which participants experience catastrophic thinking during painful experiences	Baseline, 3 months, 6 months, 12 months
Acceptance and Action Questionnaire (AAQ-II)	7-item questionnaire designed to measure psychological inflexibility	Baseline, 3 months, 6 months, 12 months
Central Sensitization Inventory (CSI)	25-item questionnaire designed to measure hypersensitivity to senses and signs of central sensitization	Baseline, 3 months, 6 months, 12 months
Pain sensitivity: Pressure pain thresholds	Designed to measure central hyperexcitability using a digital pressure algometer measured pressure that is first perceived as painful and recorded in kg	Baseline, 6 months, 12 months
Central sensitization: Temporal summation	Designed to measure central pain mediation using weighted pinprick probes	Baseline, 6 months, 12 months
Generalized Anxiety Disorder Screener (GAD-7)	7-item assessment of symptoms of anxiety over the past two weeks	Baseline, 3 months, 6 months, 12 months
Chronic Pain Self-Efficacy Scale: Function Self-Efficacy Subscale (FSE)	9-item questionnaire designed to measure chronic pain patients' perceived self-efficacy for engaging in activities	Baseline, 3 months, 6 months, 12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Healthcare Utilization	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	Baseline, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 9 months, 12 months
Five-level EuroQoL-5 Dimensions (5L EQ-5D)	5-item assessment of current health utility, plus 0 to 100 rating of overall health; QALYS will be derived from utility estimates	Baseline, 3 months, 6 months, 12 months

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: University of Pittsburgh Medical Center
• Investigators: Principal Investigator: Dana Bovbjerg, PhD, University of Pittsburgh Medical Center; Principal Investigator: Rebecca Shelby, PhD, Duke University

Publications and helpful links

General Publications

• Stalls JM, Bovbjerg DH, Somers TJ, Plumb Vilardaga JC, Kimmick GG, McAuliffe PF, Keefe FJ, Posluszny DM, Sullivan MJL, Erkanli A, Reed SD, Sutton L, Owen L, Massa L, Shelby RA. 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. Contemp Clin Trials. 2022 Nov;122:106934. doi: 10.1016/j.cct.2022.106934. Epub 2022 Sep 21.

Study record dates

Study Major Dates

• Study Start (Actual): June 8, 2021
• Primary Completion (Estimated): April 30, 2025
• Study Completion (Estimated): April 30, 2025

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): September 28, 2023
• Last Update Submitted That Met QC Criteria: September 25, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• 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