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| Sponsor: | Cancer and Leukemia Group B |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00068328 |
Purpose
RATIONALE: Studying how older women make treatment decisions and how these decisions affect the outcome of treatment may help doctors plan more effective treatments and improve patient quality of life.
PURPOSE: This clinical trial is studying how a patient's treatment preferences and decisions about chemotherapy affect the outcome of treatment in older women with newly diagnosed breast cancer.
| Condition | Intervention |
|---|---|
|
Breast Cancer Psychosocial Effects of Cancer and Its Treatment |
Procedure: psychosocial assessment and care Procedure: quality-of-life assessment |
| Study Type: | Interventional |
| Official Title: | Observational Cohort Study: Chemotherapy Decisions and Outcomes in Women Age 65 or Older With Operable, Newly Diagnosed Breast Cancer |
| Estimated Enrollment: | 1360 |
| Study Start Date: | August 2003 |
| Estimated Primary Completion Date: | July 2005 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a cohort study.
Patients participate in interviews over 30-45 minutes at baseline, at 6 months, and at 1 and 2 years.
Patients are followed annually for at least 5 years.
PROJECTED ACCRUAL: A total of 1,296 patients will be accrued for this study within 18-24 months.
Eligibility| Ages Eligible for Study: | 65 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed primary adenocarcinoma of the breast
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age
Sex
Menopausal status
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Contacts and Locations
Show 70 Study Locations| Study Chair: | Jeanne Mandelblatt, MD, MPH | Lombardi Cancer Research Center |
| Investigator: | Alice B. Kornblith, PhD | Dana-Farber Cancer Institute |
| Investigator: | Hyman B. Muss, MD | University of Vermont |
| Investigator: | Stephen B. Edge, MD | Roswell Park Cancer Institute |
More Information
| Study ID Numbers: | CDR0000321396, CALGB-369901 |
| Study First Received: | September 10, 2003 |
| Last Updated: | November 17, 2009 |
| ClinicalTrials.gov Identifier: | NCT00068328 History of Changes |
| Health Authority: | Unspecified |
|
psychosocial effects of cancer and its treatment stage I breast cancer stage II breast cancer |
stage IIIA breast cancer stage IIIB breast cancer stage IIIC breast cancer |
|
Neoplasms Neoplasms by Site Skin Diseases Breast Neoplasms Breast Diseases |