Quality of Life in African-American or Caucasian Female Breast Cancer Survivors
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|ClinicalTrials.gov Identifier: NCT00268502|
Recruitment Status : Completed
First Posted : December 22, 2005
Last Update Posted : November 16, 2015
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.
|Condition or disease||Intervention/treatment|
|Breast Cancer Cancer Survivor Depression Fatigue Sexual Dysfunction Sleep Disorders Spiritual Concerns||Other: study of socioeconomic and demographic variables Procedure: fatigue assessment and management Procedure: management of therapy complications Procedure: psychosocial assessment and care Procedure: quality-of-life assessment|
- 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.
|Study Type :||Observational|
|Estimated Enrollment :||195 participants|
|Official Title:||Survey of the Quality of Life of Women|
|Study Start Date :||December 2005|
|Actual Primary Completion Date :||November 2007|
|Actual Study Completion Date :||April 2014|
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): NCT00268502
|United States, Indiana|
|Indiana University Melvin and Bren Simon Cancer Center|
|Indianapolis, Indiana, United States, 46202-5289|
|Study Chair:||Kathleen Russell, RN, DNS||Indiana University Melvin and Bren Simon Cancer Center|