Patient case: 67-year-old female with Breast cancer. Genetic variant: FGFR1 Amplification, PTEN (Q171). Other conditions: Depression, Hypertension, Heart Disease.

Clinical trial: Measuring Stress in Women With Newly Diagnosed Stage I, Stage II, or Stage III Breast Cancer or Ductal Carcinoma In Situ of the Breast

Summary: RATIONALE: Gathering information about how patients respond to stress and measuring stress levels in women with newly diagnosed breast cancer may help doctors provide better methods of treatment and on-going care.
  PURPOSE: This research study is measuring stress in women with newly diagnosed stage I, stage II, or stage III breast cancer or ductal carcinoma in situ of the breast.

Detailed description: OBJECTIVES:
  Primary
  -  Describe the distributions of physiologic, psychosocial, and behavioral response to stress in women with newly diagnosed breast cancer.
  -  Describe the patterns of diurnal cortisol rhythms in women newly diagnosed with breast cancer.
  Secondary
  -  Determine if diurnal salivary cortisol (mean or pattern) is consistent over two days within two weeks of study entry.
  -  Assess the changes in diurnal cortisol rhythm pattern and night-time urinary epinephrine excretion change after an intervening stress event (pre- to post-surgery).
  -  Determine if the diurnal cortisol rhythm and the night-time urinary excretion correlate with a variety of self-reported psychosocial factors: optimism (LOT-R), state and trait anxiety (STAI form Y-2), positive and negative affect (PANAS), depressive symptoms (CES-D), coping (Brief COPE), and perceived stress (PSS-10).
  -  Determine if the diurnal cortisol rhythm and the night-time urinary epinephrine excretion correlate with socioeconomic stress and discrimination (functional social support and discrimination [EOD]).
  -  Determine if the diurnal cortisol rhythm and the night-time urinary epinephrine excretion correlate with one lifestyle behavior and dietary fat consumption (Block food screener).
  OUTLINE: Patients are stratified according to race (Caucasian vs African American).
  Patients are instructed to collect saliva and urine samples on 2 separate days, within 2 weeks of study enrollment. Saliva samples are collected 6 times a day at baseline, before breast cancer surgery, and 7-10 days after surgery. Urine samples are collected after midnight until and including the first morning sample on the saliva-collection days.
  Patients also complete questionnaires (either by telephone interview or in person) within 2 weeks of study enrollment and 7-10 days after breast surgery. Stress measures examined include optimism (LOT-R), trait-anxiety scale (STAI form Y-2), functional social support, affect and depression (PANAS and CES-D), perceived stress (PSS-10), economic hardship scales, discrimination (EOD), coping mechanisms (Brief COPE), and dietary fat consumption (Block Sugar/Fat/Fruit/Vegetable screener).

Eligibility: Inclusion Criteria:
  -  Diagnosed with stage I-III invasive breast cancer or ductal carcinoma in situ of the breast within the past 2 weeks
  -  Surgery for breast cancer planned
  -  Hormone receptor status not specified
  -  Female
  -  Menopausal status not specified
  -  Able to refrain from:
  -  Smoking cigarettes for the 24-hour period of saliva-sample collection
  -  Brushing teeth or eating for up to one hour prior to saliva collection
  -  More than 1 year since prior therapy for another malignancy
  -  At least 1 month since prior withdrawal from hormone-replacement product
  -  Able to refrain from steroid inhalers for greater than 24 hours
  -  No chronic oral steroids

Relevance to patient case: not relevant