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Sponsored by: |
International Breast Cancer Study Group |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00343616 |
RATIONALE: Studying cognitive function, such as thinking, attention, concentration, and memory, in postmenopausal women receiving hormone therapy for breast cancer may help improve quality of life and the ability to plan treatment for cancer.
PURPOSE: This phase III trial is studying cognitive function in postmenopausal women with breast cancer receiving hormone therapy on clinical trial IBCSG-1-98.
Condition | Intervention | Phase |
---|---|---|
Breast Cancer Cancer-Related Problem/Condition Fatigue |
Procedure: cognitive assessment Procedure: fatigue assessment and management Procedure: management of therapy complications Procedure: psychosocial assessment and care Procedure: quality-of-life assessment |
Phase III |
Study Type: | Observational |
Official Title: | Investigating Cognitive Function for Patients Participating in the BIG Trial 1-98 in Select Centers |
Estimated Enrollment: | 148 |
Study Start Date: | April 2005 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a longitudinal, multicenter study.
Patients undergo cognitive function testing and complete self-reported questionnaires regarding cognitive ability, quality of life, fatigue, and psychosocial status during the fifth year of adjuvant hormonal therapy on protocol IBCSG-1-98 and then during the sixth year* (post randomization on protocol IBCSG-1-98) (i.e., after completion of adjuvant hormonal therapy).
NOTE: *Patients who receive extended letrozole, hormone replacement therapy, or other endocrine therapy beyond 5 years do not undergo the 6-year assessment.
PROJECTED ACCRUAL: A total of 148 patients will be accrued for this study.
Ages Eligible for Study: | 30 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Enrolled in protocol IBCSG-1-98
Hormone receptor status
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Australia, New South Wales | |
Institute of Oncology at Prince of Wales Hospital | |
Randwick, New South Wales, Australia, 2031 | |
Australia, Victoria | |
Cabrini Hospital | |
Malvern, Victoria, Australia, 3144 | |
Peter MacCallum Cancer Centre | |
East Melbourne, Victoria, Australia, 3002 | |
St. Vincent's Hospital - Melbourne | |
Fitzroy, Victoria, Australia, 3065 | |
Belgium | |
Institut Jules Bordet | |
Brussels, Belgium, 1000 | |
Italy | |
European Institute of Oncology | |
Milan, Italy, 20141 | |
New Zealand | |
Auckland City Hospital | |
Auckland, New Zealand, 1 | |
Switzerland | |
International Breast Cancer Study Group | |
Bern, Switzerland, CH-3008 | |
Kantonsspital - St. Gallen | |
St. Gallen, Switzerland, CH-9007 | |
Oncology Institute of Southern Switzerland | |
Bellinzona, Switzerland, CH-6500 | |
Universitaetsspital-Basel | |
Basel, Switzerland, CH-4031 | |
United Kingdom, Scotland | |
Ninewells Hospital | |
Dundee, Scotland, United Kingdom, DD1 9SY |
Study Chair: | Kelly-Anne Phillips | Peter MacCallum Cancer Centre, Australia |
Investigator: | Jurg Bernhard, PhD | International Breast Cancer Study Group |
Study ID Numbers: | CDR0000482396, IBCSG-18-98-CFS, IBCSG-1-98-CFS, NOVARTIS-2026703019, EU-20624 |
Study First Received: | June 22, 2006 |
Last Updated: | October 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00343616 |
Health Authority: | United States: Federal Government |
cognitive/functional effects fatigue psychosocial effects/treatment |
stage I breast cancer stage II breast cancer stage IIIA breast cancer |
Signs and Symptoms Fatigue Skin Diseases Breast Neoplasms Breast Diseases |
Neoplasms Neoplasms by Site |