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| Sponsors and Collaborators: |
Indiana University Melvin and Bren Simon Cancer Center National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00268502 |
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-Related Problem/Condition Fatigue |
Procedure: fatigue assessment and management Procedure: management of therapy complications Procedure: psychosocial assessment and care Procedure: quality-of-life assessment Procedure: study of socioeconomic and demographic variables |
| Study Type: | Observational |
| Official Title: | Survey of the Quality of Life of Women |
| Estimated Enrollment: | 195 |
| Study Start Date: | December 2005 |
| Primary Completion Date: | November 2007 (Final data collection date for primary outcome measure) |
OBJECTIVES:
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 |
DISEASE CHARACTERISTICS:
Meets 1 of the following criteria:
African-American or Caucasian breast cancer survivor
Healthy African-American
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Contacts and 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 | |
| Study Chair: | Kathleen Russell, RN, DNS | Indiana University Melvin and Bren Simon Cancer Center |
More Information
| Study ID Numbers: | CDR0000459904, IUMC-0209-08B, IUMC-0502-01B |
| Study First Received: | December 20, 2005 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00268502 History of Changes |
| Health Authority: | Unspecified |
|
quality of life fatigue depression spiritual concerns sexual dysfunction and infertility sleep disorders |
stage I breast cancer stage II breast cancer stage IIIA breast cancer stage IIIB breast cancer stage IIIC breast cancer |
|
Signs and Symptoms Infertility Depression Fatigue Skin Diseases |
Quality of Life Sleep Disorders Breast Neoplasms Depressive Disorder Breast Diseases |
|
Signs and Symptoms Neoplasms Neoplasms by Site Fatigue |
Skin Diseases Breast Neoplasms Breast Diseases |
