Well-Being After Breast Cancer Surgery: Targeted-PCST for Persistent Post-Mastectomy Pain

• ClinicalTrials.gov Identifier: NCT04225585
• Recruitment Status: Recruiting
• First Posted: January 13, 2020
• Last Update Posted: June 24, 2021
• 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 test a skills training program to help with coping skills for pain that was designed specifically for women with persistent pain after breast cancer surgery.

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

Detailed Description:

Persistent pain following breast cancer surgery 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 cancer 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 (Targeted PCST) and aims to reduce pain catastrophizing, increase self-efficacy for engaging in valued activities, and decrease psychological inflexibility. We propose a multiple-site, randomized clinical trial to evaluate the efficacy of the Targeted-PCST 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) Targeted-PCST, 2) a general health education intervention (control), or 3) enhanced usual care (control). 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 Targeted-PCST 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 Targeted-PCST on pain catastrophizing, pain self-efficacy, and psychological inflexibility, and evaluate these variables as possible mediators of the benefits of Targeted-PCST. Aim 3: Evaluate the impact of Targeted-PCST 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: 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

Arms and Interventions

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)	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)	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

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: Female
• Accepts Healthy Volunteers: No

Criteria

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

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; Not yet 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

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