Breast Cancer, Hot Flashes
Conditions
Keywords
breast cancer in situ, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, hot flashes
Brief summary
RATIONALE: Gathering information about the frequency and intensity of hot flashes in patients with breast cancer and in patients who have a high risk of developing breast cancer may help doctors learn more about menopausal symptoms. PURPOSE: This clinical trial is looking at menopausal symptoms in women with breast cancer or at high risk of breast cancer who received treatment on another clinical trial.
Detailed description
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.
Interventions
OTHERinformational intervention
Data from an archived database of a closed clinical trial is retrieved.
Sponsors
National Cancer Institute (NCI)
Case Comprehensive Cancer Center
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Personal or family history of carcinoma in situ of the breast or invasive breast cancer * Treated with sertraline hydrochloride or a placebo on a clinical trial (that is now closed) at the Baylor College of Medicine-The Methodist Hospital Breast Cancer Center * Reported hot flashes with a hot flash rating of \> 15 (frequency and severity) for 1 week (before starting treatment with sertraline hydrochloride or a placebo) * No progressive metastatic breast cancer * Hormone receptor status not specified PATIENT CHARACTERISTICS: * Female * Menopausal status not specified PRIOR CONCURRENT THERAPY: * See Disease Characteristics
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Retrieval and analysis of data regarding the frequency and intensity of hot flashes | Up to one year | Data from an archived database of a closed clinical trial is retrieved. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of psychosocial and quality of life scales (i.e., FACT-B and POMS) | Up to one year | 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. |
Countries
United States
Outcome results
None listed