Trial Information

Menopausal Symptoms in Women With Breast Cancer

OBJECTIVES:

- Retrieve data from an archived database of a closed clinical trial that involved
treatment with sertraline hydrochloride or a placebo for the management of hot flashes
or other menopausal symptoms in women with breast cancer or at high risk of breast
cancer.

- Analyze the results of this closed clinical trial so that they can be published.

OUTLINE: Data from an archived database of a closed clinical trial is retrieved. Descriptive
analyses of outcome variables (e.g., menopausal symptoms, including number and intensity of
hot flashes, and psychosocial and quality of life scales) are conducted to gain insight into
their distributional aspects. Data is analyzed using ANOVA with repeated measures to account
for the changes within a patient over time as a function of treatment assignment. Summary
scores from the psychosocial scales that are reasonably complete (i.e., FACT-B and POMS) are
examined using mixed linear models to account for patient-specific differences, treatment
effects, and variable patterns of completeness.