Well-Being After Breast Cancer Surgery (WB ABCs)

• ClinicalTrials.gov Identifier: NCT04225585
• Recruitment Status: Recruiting
• First Posted: January 13, 2020
• Last Update Posted: February 9, 2023
• Sponsor: Duke University
• Collaborator: University of Pittsburgh Medical Center
• Information provided by (Responsible Party): Duke University

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Coping Skills Training for Persistent Post-Surgical Pain; General Health Education	Behavioral: CST-PSP; Behavioral: General health education	Not Applicable

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 Design

• 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

Arms and Interventions

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 Name: 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

Outcome Measures

Primary Outcome Measures :

1. 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)

Secondary Outcome Measures :

1. 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
2. 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
3. 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
4. Acceptance and Action Questionnaire (AAQ-II) [ Time Frame: Baseline, 3 months, 6 months, 12 months ]
   7-item questionnaire designed to measure psychological inflexibility
5. 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
6. 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
7. Central sensitization: Temporal summation [ Time Frame: Baseline, 6 months, 12 months ]
   Designed to measure central pain mediation using weighted pinprick probes
8. 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
9. 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

Other Outcome Measures:

1. 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
2. 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

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Contacts

Contact: Rebecca Shelby, PhD; 919-416-3410; rebecca.shelby@duke.edu

Contact: Dana Bovbjerg, PhD; 412-623-5965; bovbjergdh@upmc.edu

Locations

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

Sponsors and Collaborators

Duke University

University of Pittsburgh Medical Center

Investigators

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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Duke University
• ClinicalTrials.gov Identifier: NCT04225585
• Other Study ID Numbers: Pro00104214
• First Posted: January 13, 2020
• 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

Additional relevant MeSH terms:

Pain, Postoperative; Postoperative Complications; Pathologic Processes; Pain; Neurologic Manifestations