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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
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Indiana University

Brief Summary:

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

Detailed Description:


  • 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
Primary Completion Date : November 2007
Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • 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


  • Female


  • See Disease Characteristics

Information from the National Library of Medicine

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
Sponsors and Collaborators
Indiana University
National Cancer Institute (NCI)
Study Chair: Kathleen Russell, RN, DNS Indiana University Melvin and Bren Simon Cancer Center

Responsible Party: Indiana University
ClinicalTrials.gov Identifier: NCT00268502     History of Changes
Other Study ID Numbers: IUMC-0209-08B
CDR0000459904 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: December 22, 2005    Key Record Dates
Last Update Posted: November 16, 2015
Last Verified: November 2015

Keywords provided by Indiana University:
spiritual concerns
sexual dysfunction
sleep disorders
cancer survivor
stage IA breast cancer
stage IB breast cancer
stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Sleep Wake Disorders
Neoplasms by Site
Breast Diseases
Skin Diseases
Behavioral Symptoms
Signs and Symptoms
Nervous System Diseases
Neurologic Manifestations
Mental Disorders