Measuring Stress in Women With Newly Diagnosed Stage I, Stage II, or Stage III Breast Cancer or Ductal Carcinoma In Situ of the Breast
|ClinicalTrials.gov Identifier: NCT00665782|
Recruitment Status : Completed
First Posted : April 24, 2008
Last Update Posted : June 1, 2017
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.
|Condition or disease||Intervention/treatment|
|Anxiety Disorder Breast Cancer Depression Psychosocial Effects of Cancer and Its Treatment||Other: laboratory biomarker analysis Other: questionnaire administration Other: study of socioeconomic and demographic variables Procedure: assessment of therapy complications Procedure: psychosocial assessment and care Procedure: therapeutic conventional surgery|
- 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.
- 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).
|Study Type :||Observational|
|Actual Enrollment :||24 participants|
|Official Title:||Stress Measures in Women With Newly Diagnosed Breast Cancer|
|Study Start Date :||March 2008|
|Primary Completion Date :||July 2010|
|Study Completion Date :||July 2010|
- Diurnal cortisol rhythm [ Time Frame: Up to 10 days ]
- Consistency of diurnal salivary cortisol levels over two days [ Time Frame: Up to 10 days ]
- Changes in diurnal cortisol rhythm pattern and night-time urinary epinephrine excretion pre- to post-surgery [ Time Frame: Up to 10 days ]
- Correlation of the diurnal cortisol rhythm and the night-time urinary excretion with the measures of psychosocial and behavioral stress responses [ Time Frame: Up to 10 days ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00665782
|United States, North Carolina|
|Wake Forest University Comprehensive Cancer Center|
|Winston-Salem, North Carolina, United States, 27157-1096|
|Study Chair:||Julia A. Lawrence||Wake Forest University Health Sciences|