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Sponsors and Collaborators: |
Wake Forest University National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00665782 |
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 | Intervention |
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Breast Cancer Cancer-Related Problem/Condition |
Procedure: assessment of therapy complications Procedure: laboratory biomarker analysis Procedure: psychosocial assessment and care Procedure: questionnaire administration Procedure: study of socioeconomic and demographic variables Procedure: therapeutic conventional surgery |
Study Type: | Observational |
Official Title: | Stress Measures in Women With Newly Diagnosed Breast Cancer |
Estimated Enrollment: | 60 |
Study Start Date: | March 2008 |
Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
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).
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Able to refrain from:
PRIOR CONCURRENT THERAPY:
United States, North Carolina | |
Wake Forest University Comprehensive Cancer Center | Recruiting |
Winston-Salem, North Carolina, United States, 27157-1096 | |
Contact: Clinical Trials Office - Wake Forest University Comprehensive 336-713-6771 |
Study Chair: | Julia A. Lawrence | Wake Forest University |
Study ID Numbers: | CDR0000586701, CCCWFU-97307 |
Study First Received: | April 23, 2008 |
Last Updated: | December 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00665782 |
Health Authority: | Unspecified |
anxiety disorder depression psychosocial effects/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 |
Depression Skin Diseases Breast Neoplasms Stress Depressive Disorder Carcinoma Carcinoma, Ductal |
Anxiety Disorders Carcinoma in Situ Carcinoma, Intraductal, Noninfiltrating Carcinoma, Ductal, Breast Adenocarcinoma Breast Diseases Neoplasms, Glandular and Epithelial |
Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Ductal, Lobular, and Medullary |