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

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

Inclusion Criteria:

1. prior diagnosis of Stage 0 to Stage III breast cancer

2. received first breast surgery of total or partial mastectomy within the previous 6
weeks

3. report average pain > 3 during the first month after surgery on the Breast Cancer Pain
Questionnaire

4. with sufficient ability to communicate in English in order to provide informed consent
and complete study procedures and materials.

Exclusion Criteria:

1. < 21 years of age

2. history of prior breast cancer surgery

3. cognitive impairment documented in the medical record

4. unable to provide meaningful consent