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Completed

NCT Number: NCT04225585

Well-Being After Breast Cancer Surgery

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Medical Center, Durham, North Carolina, United States

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About this study

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=316) 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CST-PSP

Behavioral

skills training and experiential learning exercises

Other names: Coping Skills Training for Persistent Post-Surgical Pain

General health education

Behavioral

general health education intervention that focuses on improving overall health

Primary outcomes

  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 outcomes

  1. Change in emotional distress: Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS)

    Time frame: Baseline, 3 months, 6 months, 12 months

    Composite score of 8-item assessment of depressive symptoms over the past two weeks and 7-item assessment of symptoms of anxiety over the past two weeks

  2. Change in pain catastrophizing: 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

  3. Change in Central sensitization: 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

  4. Change in Central sensitization: Temporal summation

    Time frame: Baseline, 6 months, 12 months

    Designed to measure central pain mediation using weighted pinprick probes

Other outcomes

  1. Change in cancer-specific distress: 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

  2. Change in psychological inflexibility: Acceptance and Action Questionnaire (AAQ-II)

    Time frame: Baseline, 3 months, 6 months, 12 months

    7-item questionnaire designed to measure psychological inflexibility

  3. Change in self-efficacy: 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

  4. Change in 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

  5. Change in Pain sensitivity: Mechanical cutaneous pain thresholds

    Time frame: Baseline, 6 months, 12 months

    Assessed using weighted pinprick probes with standard stimulus intensities (8, 16, 32, 64, 128, 256, and 512 mN) and contact areas (tip diameter 0.20 mm). Stimuli are applied to the middle phalanx of digit 3, beginning with the lowest-force stimulator until the suprathreshold value is reached. The direction of the testing is then changed toward lower stimulus intensities until the probe stimulation is perceived as 'touch' only (sub-threshold value). Testing then directs again toward higher intensities, until 5 suprathreshold and 5 subthreshold values have been recorded.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • University of Pittsburgh Medical Center

Registry information

Official study 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

Acronym: WB ABCs

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Jan 13, 2020
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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