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

NCT ID: NCT00268502

Last Updated: 2015-11-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 195 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2005-12-31
• Study Completion Date: 2014-04-30

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.

Conditions

Breast Cancer; Cancer Survivor; Depression; Fatigue; Sexual Dysfunction; Sleep Disorders; Spiritual Concerns

Interventions

study of socioeconomic and demographic variables

Intervention Type: OTHER

fatigue assessment and management

Intervention Type: PROCEDURE

management of therapy complications

Intervention Type: PROCEDURE

psychosocial assessment and care

Intervention Type: PROCEDURE

quality-of-life assessment

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kathleen Russell, RN, DNS

Role: STUDY_CHAIR

Indiana University Melvin and Bren Simon Cancer Center

Locations

Indiana University Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, United States

Countries

United States

Other Identifiers

CDR0000459904

Identifier Type: REGISTRY

Identifier Source: secondary_id

IUMC-0502-01B

Identifier Type: -

Identifier Source: secondary_id

IUMC-0209-08B

Identifier Type: -

Identifier Source: org_study_id