Well-Being After Breast Cancer Surgery

Not Applicable

Recruiting

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

• Registration Number: NCT04225585
• Lead Sponsor: Duke University

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.

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 Timeline

• Study First Submitted: 2020-01-03
• Study First Submitted QC: 2020-01-09
• Study First Posted: 2020-01-13
• Study Start: 2021-06-08
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-25
• Last Update Posted: 2023-09-28
• Primary Completion: 2025-04-30
• Study Completion: 2025-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 307

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Coping Skills Training for Persistent Post-Surgical Pain	CST-PSP	novel pain coping skills training intervention designed specifically for people with persistent pain (PP) following breast cancer surgery
Self-guided health education	General health education	general health education intervention
General health education with a coach	General health education	general health education intervention

Primary Outcome Measures

Name	Time	Method
Change in PEG Pain Severity and Interference	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

Name	Time	Method
Patient Health Questionnaire Depression Screener (PHQ-9)	Baseline, 3 months, 6 months, 12 months	9-item assessment of depressive symptoms over the past two weeks
Impact of Event Scale (IES)	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)	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)	Baseline, 3 months, 6 months, 12 months	7-item questionnaire designed to measure psychological inflexibility
Central sensitization: Temporal summation	Baseline, 6 months, 12 months	Designed to measure central pain mediation using weighted pinprick probes
Central Sensitization Inventory (CSI)	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	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
Generalized Anxiety Disorder Screener (GAD-7)	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)	Baseline, 3 months, 6 months, 12 months	9-item questionnaire designed to measure chronic pain patients' perceived self-efficacy for engaging in activities

Trial Locations

Locations (2)

University of Pittsburgh Medical Center; 🇺🇸 Pittsburgh, Pennsylvania, United States

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States