Clinical trial NCT00268502: 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
Overall status: COMPLETED
Conditions: 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
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2005-12-22
Enrollment: 195
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

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.

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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University Melvin and Bren Simon Cancer Center
state: Indiana
Study officials:
affiliation: Indiana University Melvin and Bren Simon Cancer Center
name: Kathleen Russell, RN, DNS
role: STUDY_CHAIR
References: