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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2007 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00268502
First received: December 20, 2005
Last updated: February 19, 2012
Last verified: March 2007
  Purpose

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
Depression
Fatigue
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 National Cancer Institute (NCI):

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00268502

Locations
United States, Indiana
Indiana University Melvin and Bren Simon Cancer Center Recruiting
Indianapolis, Indiana, United States, 46202-5289
Contact: Clinical Trials Office - Indiana University Cancer Center    317-274-2552      
Sponsors and Collaborators
Indiana University Melvin and Bren Simon Cancer Center
Investigators
Study Chair: Kathleen Russell, RN, DNS Indiana University Melvin and Bren Simon Cancer Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00268502     History of Changes
Other Study ID Numbers: CDR0000459904, IUMC-0209-08B, IUMC-0502-01B
Study First Received: December 20, 2005
Last Updated: February 19, 2012
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
sexual dysfunction
fatigue
depression
spiritual concerns
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
Depression
Depressive Disorder
Fatigue
Sleep Disorders
Parasomnias
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Behavioral Symptoms
Mood Disorders
Mental Disorders
Signs and Symptoms
Nervous System Diseases
Neurologic Manifestations

ClinicalTrials.gov processed this record on August 20, 2014