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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

December 20, 2005

Last Updated Date

May 9, 2009

Start Date ^†

December 2005

Current Primary Outcome Measures ^†

Original Primary Outcome Measures ^†

Change History

Complete list of historical versions of study NCT00268502 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Original Secondary Outcome Measures ^†

Descriptive Information

Brief Title ^†

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

Official Title ^†

Survey of the Quality of Life of Women

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.

Detailed Description

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.

Study Phase

Study Type ^†

Observational

Study Design ^†

Condition ^†

Breast Cancer
Depression
Fatigue
Quality of Life
Sexual Dysfunction and Infertility
Sleep Disorders
Spiritual Concerns

Intervention ^†

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 Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Recruiting

Enrollment ^†

195

Completion Date

Primary Completion Date

November 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^†

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

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00268502

Responsible Party

Secondary IDs ^††

IUMC-0209-08B, IUMC-0502-01B

Study Sponsor ^†

Indiana University Melvin and Bren Simon Cancer Center

Collaborators ^††

National Cancer Institute (NCI)

Investigators ^†

Study Chair:

Kathleen Russell, RN, DNS

Indiana University Melvin and Bren Simon Cancer Center

Information Provided By

National Cancer Institute (NCI)

Verification Date

March 2007

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.