Well-Being After Breast Cancer Surgery

General Health Education Clinical Trial

— WB ABCs  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04225585
• Other study ID #: Pro00104214
• Status: Recruiting
• Phase: N/A
• Start date: June 8, 2021
• Est. completion date: April 30, 2025

Study information

• Verified date: September 2023
• Source: Duke University
• Contact: Rebecca Shelby, PhD
• Phone: 919-416-3410
• Email: rebecca.shelby[@]duke.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 307
• Est. completion date: April 30, 2025
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• General Health Education
• Pain, Postoperative

Intervention

Behavioral:
• CST-PSP
skills training and experiential learning exercises
• General health education
general health education intervention that focuses on improving overall health

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	University of Pittsburgh Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	Acceptance and Action Questionnaire (AAQ-II)	7-item questionnaire designed to measure psychological inflexibility	Baseline, 3 months, 6 months, 12 months
Secondary	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
Secondary	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
Secondary	Central sensitization: Temporal summation	Designed to measure central pain mediation using weighted pinprick probes	Baseline, 6 months, 12 months
Secondary	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
Secondary	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