This is a proposal to serve as a statistical coordinating center for a multi-institutional randomized clinical trial of a low fat diet aimed at prolonging the disease-free survival and overall survival in stage II breast cancer patients. Three phases of the project include the protocol development, feasibility and implementation phases. In the protocol development the investigators from NCI, the clinical, the nutritional, and coordinating centers will develop a protocol for recruitment, treatment, dietary education), and data management and analyses plans. In the feasibility phase, a sample of 200 in the treatment group and 100 in the control group seem adequate for assessing compliance with the 20% low fat diet and any adverse effects of the treatment. With modification of existing clinical data collection and 24 hour - frequency nutritional dieting assessment instruments, the data collection and management system using the IBM XT as data entry work stations with a DEC 11 minicomputer for analysis should offer the speed and economy necessary for an effective feasibility study. Assuming that the feasibility phase indicates patients can comply with a low fat diet, and implementation phase will be initiated with a sample size of 2000. With only slight modifications to the instruments and protocol, the same data collection card arrangement systems could be enlarged to accommodate the additional work load.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Research Project--Cooperative Agreements (U01)
Project #
3U01CA037583-01S1
Application #
3548420
Study Section
(SRC)
Project Start
1984-07-01
Project End
1986-04-30
Budget Start
1984-07-01
Budget End
1986-04-30
Support Year
1
Fiscal Year
1985
Total Cost
Indirect Cost
Name
University of California Los Angeles
Department
Type
Schools of Public Health
DUNS #
119132785
City
Los Angeles
State
CA
Country
United States
Zip Code
90095