Measuring Stress in Women With Newly Diagnosed Stage I, Stage II, or Stage III Breast Cancer or Ductal Carcinoma In Situ of the Breast
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|ClinicalTrials.gov Identifier: NCT00665782|
Recruitment Status : Completed
First Posted : April 24, 2008
Last Update Posted : July 3, 2018
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|
|Actual Primary Completion Date :||July 2010|
|Actual 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|