Quality of Life in African-American or Caucasian Female Breast Cancer Survivors
|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|
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|