Measuring Stress in Women With Newly Diagnosed Stage I, Stage II, or Stage III Breast Cancer or Ductal Carcinoma In Situ of the Breast
Condition: Anxiety Disorder; Breast Cancer; Depression; Psychosocial Effects of Cancer and Its Treatment
MeSH terms: Breast Neoplasms; Carcinoma in Situ; Depression; Anxiety Disorders
Study type: Observational

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).
    

Intervention name(s): laboratory biomarker analysis; questionnaire administration; study of socioeconomic and demographic variables; assessment of therapy complications; psychosocial assessment and care; therapeutic conventional surgery
Intervention type(s): Other; Other; Other; Procedure; Procedure; Procedure
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Those diagnosed with stage I-III invasive breast cancer or ductal carcinoma in situ of the
        breast within the past 2 weeks
      
Keywords: anxiety disorder; depression; psychosocial effects of cancer and its treatment; ductal breast carcinoma in situ; breast cancer in situ; stage I breast cancer; stage II breast cancer; stage IIIA breast cancer; stage IIIB breast cancer; stage IIIC breast cancer