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

Breast Cancer Clinical Trial

Official title:

Survey of the Quality of Life of Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00268502
• Other study ID #: IUMC-0209-08B
• Secondary ID: CDR0000459904IUM
• Status: Completed
• Phase: N/A
• First received: December 20, 2005
• Last updated: November 12, 2015
• Start date: December 2005
• Est. completion date: April 2014

Study information

• Verified date: November 2015
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 195
• Est. completion date: April 2014
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 120 Years

Eligibility

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

Study Design

N/A

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Cancer Survivor
• Depression
• Fatigue
• Parasomnias
• Sexual Dysfunction
• Sleep Disorders
• Spiritual Concerns

Intervention

Other:
• study of socioeconomic and demographic variables

Procedure:
• fatigue assessment and management

• management of therapy complications

• psychosocial assessment and care

• quality-of-life assessment

Locations

Country	Name	City	State
United States	Indiana University Melvin and Bren Simon Cancer Center	Indianapolis	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Indiana University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,