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CompletedNCT00268502Updated Nov 16, 2015

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

An observational study in Breast Cancer, Cancer Survivor and Depression, sponsored by Indiana University. Completed at 1 site in United States. Open to female participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2015-11-16.

Sponsored by Indiana University · Observational

Study type
Observational
Enrollment
195
Ages
18 Years to 120 Years
Sex
Female
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Study 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.

Read the 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.

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Conditions studied

  • 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
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In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's planned enrollment of 195 is close to the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Indiana University is the lead sponsor of 958 studies on the registry; 200 are open to participants now.

Of its 142 completed or terminated interventional studies of FDA-regulated products, 112 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 120 Years
Sexes eligible
Female
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
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Study design

Enrollment
195 participants (estimated)
Patient registry
No

Interventions

  • Otherstudy of socioeconomic and demographic variables
  • Procedurefatigue assessment and management
  • Proceduremanagement of therapy complications
  • Procedurepsychosocial assessment and care
  • Procedurequality-of-life assessment
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Study locations

1 site
  • Indiana University Melvin and Bren Simon Cancer Center
    Indianapolis, Indiana 46202-5289, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 16, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00268502
Lead sponsor
Indiana University
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Dec 22, 2005
Start date
Dec 2005
Primary completion
Nov 2007
Completion
Apr 2014
Last update
Nov 16, 2015

Study contacts

Kathleen Russell, RN, DNS
study chair · Indiana University Melvin and Bren Simon Cancer Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.

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