Targeted Pain Coping Skills Training (PCST) for Prevention and Treatment of Persistent Post-Mastectomy Pain

2015-05-13 18:23:21 | BioPortfolio


This study looks at whether a coping skills training program can help women manage pain and stress after breast surgery, and lower the risk of developing chronic pain. This coping skills program includes eight training sessions that are done by telephone. These sessions will focus on strategies for dealing with pain and stress, and how to apply these strategies to subjects' own experiences.


Persistent pain following breast cancer surgery is increasingly being recognized as an important clinical and public health issue due to the large numbers of women affected, the negative impact that persistent pain has on emotional and physical functioning, and its financial cost. Most of the 230,000 women that are expected to be newly diagnosed with breast cancer in the U.S. this year will undergo surgical treatment. Surgical removal of the affected breast (mastectomy) or excision of the tumor (lumpectomy) followed by radiation markedly reduces the risk of disease progression and mortality. However, women undergoing even the more limited lumpectomy are at substantial risk for persistent pain. Estimates of pain's prevalence range from 25-60% across multiple studies, with rates differing based on the stringency of the definition of persistent pain. In one recent study, 32.5% of the women who had undergone breast cancer surgery reported clinically significant persistent pain, defined as a 3/10-pain severity rating for the breast, axilla, side, or arm.

Unlike acute post-operative pain, which is considered to be a normal response to surgical trauma, persistent pain has little biological utility and has proven difficult to treat once established. A critical question is whether there are modifiable factors that contribute to the risk of developing persistent pain following breast cancer surgery that could be targeted for early, preventative intervention. To date, attempts to reduce the risk of persistent pain have focused on alterations in medical/surgical procedures; these studies have had mixed results, consistent with mixed findings in the broader literature regarding the status of medical/surgical variables as risk factors for persistent pain. In contrast, there have been multiple studies showing associations between pain catastrophizing, depression, and anxiety and persistent pain. In these studies, pain catastrophizing shows the strongest and most consistent relationship to persistent pain as evidenced in a recent meta-analysis. Consistent with the biopsychosocial theory of pain, there is also evidence from quantitative sensory testing (QST) studies that alterations in central pain modulation pathways contribute to the development of post-surgical persistent pain, including recent studies with breast cancer patients. Since pain catastrophizing has been found to be associated with pernicious alterations in central pain modulation intervening to reduce catastrophizing may be a particularly effective prevention strategy for persistent pain following breast cancer surgery. Pain coping skills training (PCST) interventions based on cognitive-behavioral principles are the only interventions demonstrated to reduce catastrophizing, alter central modulation of pain and reduce chronic pain.

The overarching hypothesis for the proposed pilot study (N=60) is that a targeted PCST protocol specifically designed for women at risk for persistent pain following breast cancer surgery (pain score of 3 or greater [0-10 scale] during the first month post-surgery) (3-5) will significantly reduce this devastating consequence of treatment compared to usual care with printed education materials.

Aim 1: To use a pilot RCT (N=60) to examine the feasibility, acceptability, and engagement in the targeted PCST protocol. Feasibility will be assessed by examining overall accrual, attrition, and adherence to the study protocol, engagement will be assessed by the use of intervention sessions and questionnaires (number completed), and acceptability will be assessed with a standardized measure of satisfaction.

Aim 2: To obtain an estimate of the effect size of the targeted PCST protocol for persistent post-surgical pain in comparison to the usual care condition. Effect sizes for group differences on pain burden, symptoms of anxiety and depression, breast cancer specific distress, perceived stress, sleep, interference with daily activities, pain catastrophizing, and hypothesized changes in peripheral sensitivity and central inhibition will also be computed.

The proposed study represents the next critical step in research examining persistent pain after surgical treatment for breast cancer. The proposed study will provide the necessary preliminary data for larger studies aimed at testing the targeted PCST intervention. This study will also provide preliminary data for future studies focused on pain sensitivity and central pain modulation in breast cancer survivors

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care


Breast Cancer


Psychosocial Intervention


Duke University Medical Center
North Carolina
United States


Not yet recruiting


Duke University

Results (where available)

View Results


Published on BioPortfolio: 2015-05-13T18:23:21-0400

Clinical Trials [6087 Associated Clinical Trials listed on BioPortfolio]

Psychosocial Intervention Pilot for Partners in BRCA Testing

A brief psychosocial intervention for partners of women affected by or at risk for breast cancer and harboring BRCA genetic alterations.

Yoga to Reduce Cancer Fatigue

A randomized trial from the British National Health Service found that supervised exercise benefits women with early stage breast cancer with improved functional and psychological benefit ...

Body Image and Psychosocial Functioning in Women With Breast Cancer: Can We Fix What We've Broken?

The purpose of this study is to test an innovative intervention geared towards issues of identity, body image and sexuality, and to examine the intervention for its impact on body image, q...

Improving Psychosocial Quality of Life in Women With Advanced Breast Cancer

Through a patient participation aid (PPA) the investigators hope to improve the psychosocial well-being of women diagnosed with metastatic breast cancer by empowering them to be active par...

Fathers and Mothers Invested in Lives of Their Youth (FAMILY) Study: A Pilot Intervention

This is a single-arm pilot study to evaluate the feasibility and acceptability of a novel psychosocial intervention to improve psychosocial outcomes for parents with advanced cancer and th...

PubMed Articles [18492 Associated PubMed Articles listed on BioPortfolio]

A Feasible and Acceptable Multicultural Psychosocial Intervention Targeting Symptom Management in the Context of Advanced Breast Cancer.

Advanced breast cancer patients around the world experience high symptom burden (i.e., distress, pain, fatigue) and are in need of psychosocial interventions that target symptom management. This study...

Exploring the efficacy of a paraprofessional delivered telephonic psychoeducational intervention on emotional well-being in African American breast cancer survivors.

African American breast cancer survivors (AABCS) are underserved in medical and psychosocial care despite greater disease burden. We evaluated the effectiveness of a telephonic psycho-educational inte...

Emotional distress and psychosocial needs in patients with breast cancer in British Columbia: younger versus older adults.

This study evaluates the prevalence of emotional distress and psychosocial needs in young adult (YA, age 18-39) patients at the time of their breast cancer diagnosis compared to older patients.

Risk Estimation, Anxiety and Breast Cancer Worry in Women at Risk for Breast Cancer: A Single-Arm Trial of Personalized Risk Communication.

Elevated anxiety and breast cancer worry can impede mammographic screening and early breast cancer detection. Genetic advances and risk models make personalized breast cancer risk assessment and commu...

The Japanese Breast Cancer Society Clinical Practice Guidelines for Breast Cancer Screening and Diagnosis, 2018 Edition.

This article updates readers as to what is new in the Japanese Breast Cancer Society Clinical Practice Guidelines for Breast Cancer Screening and Diagnosis, 2018 Edition. Breast cancer screening issue...

Medical and Biotech [MESH] Definitions

Abnormal accumulation of lymph in the arm, shoulder and breast area associated with surgical or radiation breast cancer treatments (e.g., MASTECTOMY).

Metastatic breast cancer characterized by EDEMA and ERYTHEMA of the affected breast due to LYMPHATIC METASTASIS and eventual obstruction of LYMPHATIC VESSELS by the cancer cells.

A infiltrating (invasive) breast cancer, relatively uncommon, accounting for only 5%-10% of breast tumors in most series. It is often an area of ill-defined thickening in the breast, in contrast to the dominant lump characteristic of ductal carcinoma. It is typically composed of small cells in a linear arrangement with a tendency to grow around ducts and lobules. There is likelihood of axillary nodal involvement with metastasis to meningeal and serosal surfaces. (DeVita Jr et al., Cancer: Principles & Practice of Oncology, 3d ed, p1205)

A deoxycytidine derivative and fluorouracil PRODRUG that is used as an ANTINEOPLASTIC ANTIMETABOLITE in the treatment of COLON CANCER; BREAST CANCER and GASTRIC CANCER.

Carbohydrate antigen elevated in patients with tumors of the breast, ovary, lung, and prostate as well as other disorders. The mucin is expressed normally by most glandular epithelia but shows particularly increased expression in the breast at lactation and in malignancy. It is thus an established serum marker for breast cancer.

More From BioPortfolio on "Targeted Pain Coping Skills Training (PCST) for Prevention and Treatment of Persistent Post-Mastectomy Pain"

Quick Search

Relevant Topics

Women's Health
Women's Health - key topics include breast cancer, pregnancy, menopause, stroke Follow and track Women's Health News on BioPortfolio: Women's Health News RSS Women'...

Pain is defined by the International Association for the Study of Pain as “an unpleasant sensory and emotional experience associated with actual or potential tissue damage or described in terms of such damage”. Some illnesses can be excruci...

Stress is caused by your perception of situations around you and then the reaction of your body to them. The automatic stress response to unexpected events is known as 'fight or flight'. Discovered by Walter Cannon in 1932, it is the release of h...

Searches Linking to this Trial