Menopausal Symptoms in Women With Breast Cancer
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.
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.
Status: Completed (N/A). Started on October 1st, 2007.
Enrollment: 183 subjects
Study Type: Observational
Study Design:
- Observational Model: Case-Only
- Time Perspective: Prospective
Conditions:
Interventions:
- Other: informational intervention
Eligibility
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
- Gender
Female
- Mininum Age
18 Years
- Maximum Age
N/A
- Healthy Volunteers
No
Resources
Source: Case Comprehensive Cancer Center
Authority: United States: Federal Government
Locations
-
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Cleveland
Ohio
44106
United States
Officials
Lois C. Friedman, PhD (Principal Investigator, Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center)
Sponsors
Case Comprehensive Cancer Center (Lead Sponsor)
National Cancer Institute (NCI) (Collaborator)
References
None.
Links
- Date Verified
- December 1st, 2010
- First Received
- December 16th, 2010
- Last Changed
- December 16th, 2010
Information obtained from ClinicalTrials.gov on June 09, 2011. Link to the current ClinicalTrials.gov record.
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