Persistent Post-Surgical Pain in Women With BrCA
Condition: Breast Cancer; Chronic Pain
MeSH terms: Breast Neoplasms; Chronic Pain; Pain, Postoperative
Study type: Observational

Summary: 
      Women with early-stage breast cancer (BrCA) are surviving longer, but many experience
      symptoms after curative treatments. Approximately 50% of BrCA survivors experience persistent
      pain post-surgery. Identifying individuals at high risk for long-term symptoms is important
      for restoring function and enhancing quality of life. This pilot study will investigate
      psychological (depression, anxiety, catastrophizing) and biological (inflammatory markers,
      gut microbiome, pain sensitivity) correlates of persistent post-surgical pain in women
      participants with early-stage BrCA. The investigators will also investigate the type of
      surgery that participants had and whether it is related to persistent pain. The investigators
      plan explore these factors over time.
    

Detailed description: 
      Subjects participate in a brief telephone or in-person screening to determine eligibility for
      this study. The first in-person visit to the UF Pain Clinical Research Unit (CRC) is
      scheduled to coincide with a pre-operative testing or a clinic visit. During this first
      visit, more health information is collected related to the eligibility criteria for the study
      and if the visit should proceed. The in-person screening process takes about 30 minutes. The
      Informed Consent will be reviewed to make sure that the subjects understand everything that
      is involved with the study. After consent, participants are randomly assigned, like the flip
      of a coin, a participant ID number known only to the investigators. The participants may
      choose not to continue or be excluded from the study after providing the screening
      information. The demographic and health information provided will be shredded. These names
      will be kept in a locked file, however, so that the investigators don't contact them again
      for screening. It will be indicated, next to the name and ID number, the reason for exclusion
      from the study. A copy of the signed informed consent form will remain in a locked file as
      well for documentation purposes.

      If selected for this study and agree to participate, participants will be asked to complete
      several tests. These tests will take around 2 hours, and will be done following the screening
      questions during the first visit. The first visit will take about 2 ½ hours. There will be a
      second and third visit (approximately 3 and 6 months later) to the UF Pain CRC for follow-up
      testing. Each visit will last about 2 hours. Every effort will be made to combine these
      visits with regular post-surgery follow-up visits to the clinic or your health care provider.
      Each participant's hospital medical record associated with their surgery for breast cancer
      will be assessed for the amount of pain they experienced following their surgery and the pain
      medications that they received. Information related to the type of surgery (i.e., lumpectomy,
      mastectomy, or reconstruction), the results of the biopsies and lymph node tests, the
      characteristics of the breast tumor, and information about your surgery (e.g., type of
      anesthesia, duration of surgery, surgical complications) will be collected.

      The following will occur during all 3 visits to the center. Information about health and
      medications will be collected. At the 2nd and 3rd visits, any changes to health and
      medications since the last visit will be collected. Blood pressure, heart rate, height and
      weight information will be collected from all participants. Surveys about participant's
      thoughts and feelings about pain will be conducted.

      A trained professional will draw blood (about 1-2 teaspoons) from a vein your arm. This will
      be used to measure laboratory values associated with inflammation in the body. Specifically,
      the investigators will look for biomarkers, such as chemicals and hormones that might be
      related to pain. They will also check the level of vitamin D in your blood. No fasting is
      required before these blood tests. The stored blood sample will not be labeled with the
      participant's name. It will be labeled only with the ID number. The samples will be stored in
      the University of Florida Clinical and Translational Science Biorepository.

      The Investigators will instruct participants in how to use a stool specimen kit. It will be
      used at home and returned in the mail. A stamped envelope will be provided to the
      participants with each kit. This will be used to measure microbes in your gut that are
      associated with inflammation. The stored stool sample will not be labeled with the
      participant's name. It will be labeled only with the ID number. The samples will be stored in
      a researcher's laboratory at the University of Florida. If participants are pre-menopausal
      woman, a urine pregnancy test may be required.

      Several tests to measure sensitivity and tolerance to pain will be performed.

        1. Pressure Sensation Test - applies pressure to one knee, thigh, shoulder and arm. The
           pressure may be slowly increased, and participants will be asked to tell the examiner
           when they begin to feel discomfort or mild pain. As soon as pain is felt, the pressure
           will be removed.

        2. Mechanical Sensation Test - a handheld probe that has a small nylon tip to tap the knee
           and hand. The investigator will ask participants to tell how painful this feels.

        3. Heat Pain Test - Sensitivity to heat pain will be tested using a commercially available
           sensory testing machine that is widely used in clinical settings. The machine has a
           small square piece that is used to apply heat to the skin. Heat will be applied to one
           knee and arm. The amount of heat is controlled by a computer. The procedure can be
           stopped at any time so that participants do not experience pain that is unacceptable.
    

Intervention name(s): No intervention
Intervention type(s): Other
Intervention description(s): There is no intervention in this study.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women diagnosed with early stage breast cancer, who plan to have breast surgery at UF
        Health/Shands Hospital in Gainesville, Florida
      
Biospecimen description: 
      A stool sample for microbiota analysis will be collected by participants at home using a
      standard test kit, and returned via mail. Fecal microbial DNA will be extracted from between
      50-200 mg of fecal material. The 16S ribosomal gene (V4 region) of each sample will be
      amplified using a barcoding system to allow multiplexing with the Illumina MiSeq system.

      Blood samples will be collected to measure C-reactive protein (CRP) (at each visit) and
      telomerase/telomere and 25(OH)D level at baseline and the 6-month visit. Venous blood samples
      will be collected by trained staff.