Targeted Pain Coping Skills Training (PCST) for Prevention and Treatment of Persistent Post-Mastectomy Pain
Condition: Breast Cancer
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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 9 months post-surgery) 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
    

Intervention name(s): Psychosocial Intervention
Intervention type(s): Behavioral
Intervention description(s): Telephone-based psychosocial intervention involving Eight telephone encounters. Each encounter will focus on strategies for dealing with pain and stress, and how to apply these strategies to patients own experiences.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care