Menopausal Symptoms in Women With Breast Cancer or At High Risk of Breast Cancer Treated on Another Clinical Trial

Completed

• Conditions: Breast Cancer; Hot Flashes

• Registration Number: NCT00666913
• Lead Sponsor: Case Comprehensive Cancer Center

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.

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2008-04-24
• Study First Submitted QC: 2008-04-24
• Study First Posted: 2008-04-25
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-28
• Last Update Posted: 2015-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 183

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center; 🇺🇸 Cleveland, Ohio, United States