Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| P30CA012197 | U.S. NIH Grant/Contract | View source | |
| CCCWFU-97307 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
Not provided
Not provided
Not provided
Not provided
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.
OBJECTIVES:
Primary
Secondary
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).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| laboratory biomarker analysis | Other | |||
| questionnaire administration | Other | |||
| study of socioeconomic and demographic variables | Other | |||
| assessment of therapy complications | Procedure | |||
| psychosocial assessment and care | Procedure | |||
| therapeutic conventional surgery | Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Diurnal cortisol rhythm | Up to 10 days |
| Measure | Description | Time Frame |
|---|---|---|
| Consistency of diurnal salivary cortisol levels over two days | Up to 10 days | |
| Changes in diurnal cortisol rhythm pattern and night-time urinary epinephrine excretion pre- to post-surgery | Up to 10 days |
Not provided
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:
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
Not provided
Not provided
Those diagnosed with stage I-III invasive breast cancer or ductal carcinoma in situ of the breast within the past 2 weeks
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Julia A. Lawrence | Wake Forest University Health Sciences | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest University Comprehensive Cancer Center | Winston-Salem | North Carolina | 27157-1096 | United States |
Not provided
Not provided
Not provided
Not provided
| Correlation of the diurnal cortisol rhythm and the night-time urinary excretion with the measures of psychosocial and behavioral stress responses | Up to 10 days |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001943 | Breast Neoplasms |
| D003863 | Depression |
| D002285 | Carcinoma, Intraductal, Noninfiltrating |
| D000071960 | Breast Carcinoma In Situ |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D002278 | Carcinoma in Situ |
| D018299 | Neoplasms, Ductal, Lobular, and Medullary |
Not provided
Not provided
| ID | Term |
|---|---|
| D000067250 | Psychiatric Rehabilitation |
| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
Not provided
Not provided