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

Primary Purpose

Breast Cancer, Cancer Survivor, Depression

Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
study of socioeconomic and demographic variables
fatigue assessment and management
management of therapy complications
psychosocial assessment and care
quality-of-life assessment
Sponsored by
Indiana University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Breast Cancer focused on measuring fatigue, depression, 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

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Indiana University Melvin and Bren Simon Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
December 20, 2005
Last Updated
November 12, 2015
Sponsor
Indiana University
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00268502
Brief Title
Quality of Life in African-American or Caucasian Female Breast Cancer Survivors
Official Title
Survey of the Quality of Life of Women
Study Type
Observational

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Indiana University
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Cancer Survivor, Depression, Fatigue, Sexual Dysfunction, Sleep Disorders, Spiritual Concerns
Keywords
fatigue, depression, 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

7. Study Design

Enrollment
195 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Other
Intervention Name(s)
study of socioeconomic and demographic variables
Intervention Type
Procedure
Intervention Name(s)
fatigue assessment and management
Intervention Type
Procedure
Intervention Name(s)
management of therapy complications
Intervention Type
Procedure
Intervention Name(s)
psychosocial assessment and care
Intervention Type
Procedure
Intervention Name(s)
quality-of-life assessment

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathleen Russell, RN, DNS
Organizational Affiliation
Indiana University Melvin and Bren Simon Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Indiana University Melvin and Bren Simon Cancer Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202-5289
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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