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

This study has been completed.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Indiana University Identifier:
First received: December 20, 2005
Last updated: November 12, 2015
Last verified: November 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 Intervention
Breast Cancer
Cancer Survivor
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

Study Type: Observational
Official Title: Survey of the Quality of Life of Women

Resource links provided by NLM:

Further study details as provided by Indiana University:

Estimated Enrollment: 195
Study Start Date: December 2005
Study Completion Date: April 2014
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
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.


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
  Contacts and Locations
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Please refer to this study by its identifier: 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
  More Information

Responsible Party: Indiana University Identifier: NCT00268502     History of Changes
Other Study ID Numbers: IUMC-0209-08B
CDR0000459904 ( Registry Identifier: PDQ (Physician Data Query) )
Study First Received: December 20, 2005
Last Updated: November 12, 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 processed this record on April 28, 2017