View Clinical Trial (Medical Research Study)
Survey of the Quality of Life of Women
| City: |
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Indianapolis |
| State: |
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Indiana |
| Zip Code: |
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46202 |
| Conditions: |
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Breast Cancer - Cancer Survivor - Depression - Fatigue - Sexual Dysfunction - Sleep Disorders - Spiritual Concerns |
| Purpose: |
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RATIONALE: Studying quality of life in cancer survivors may help determine the long-term
effects of breast cancer and may help improve the quality of life for future cancer
survivors.
PURPOSE: This clinical trial is studying the quality of life in African-American or
Caucasian female breast cancer survivors.
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| Study Summary: |
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OBJECTIVES:
- Compare disease-specific, generic, and global quality of life measures in
African-American survivors of breast cancer with Caucasian survivors of breast cancer.
- Compare these quality of life measures in African-American survivors of breast cancer
with control group of African-American women with no history of breast cancer.
OUTLINE: Patients and healthy participants complete a battery of quality of life (QOL)
questionnaires over approximately 65 minutes by mail or over the phone, including the Sexual
Function Index, Functional Assessment of Cancer Therapy - Fatigue, Concerns About Recurrence
Scale, and other measures of symptoms/side effects (including sleep problems), the RAND
Physical Functioning -10 Scale, Center for Epidemiologic Studies - Depression Scale,
assessment of family function/social support, ENRICH Marital Satisfaction Scale, Reed
Spiritual Perspective Scale, assessments of coping and body image, Post-Traumatic Growth
Inventory, and the Index of Well-being. Demographic, disease, treatment, and comorbidity
information, as well as menstrual and gynecological history, work status and insurance
history, and a measure of health care provider communication is collected using
questionnaires and medical chart review.
PROJECTED ACCRUAL: A total of 195 patients and healthy participants will be accrued for this
study.
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| Criteria: |
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DISEASE CHARACTERISTICS:
- Meets 1 of the following criteria:
- African-American or Caucasian breast cancer survivor
- Diagnosed with stage I-III breast cancer between the years of 1995-2003
- Receiving follow up care at the Indiana University Cancer Center (IUCC),
the IUCC Northside Clinic, Spring Mill Clinic, or Wishard Memorial Hospital
- Healthy African-American
- Acquaintance of an African-American breast cancer survivor
- Not known to have breast cancer
PATIENT CHARACTERISTICS:
- Female
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
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| NCT ID: |
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NCT00268502 |
| Primary Contact: |
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Study Chair Kathleen Russell, RN, DNS Indiana University Melvin and Bren Simon Cancer Center
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| Backup Contact: |
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N/A |
| Location Contact: |
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Indianapolis, Indiana 46202 United States
Clinical Trials Office - Indiana University Cancer Center Phone: 317-274-2552
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 19, 2013 |
| Modifications to this listing: |
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