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

September 28, 2015 updated by: Case Comprehensive Cancer Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

183

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Data from an archived database of a closed clinical trial is retrieved.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Retrieval and analysis of data regarding the frequency and intensity of hot flashes
Time Frame: Up to one year
Data from an archived database of a closed clinical trial is retrieved.
Up to one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of psychosocial and quality of life scales (i.e., FACT-B and POMS)
Time Frame: 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.
Up to one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Case Comprehensive Cancer Center

Collaborators

National Cancer Institute (NCI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

June 1, 2010

Study Registration Dates

First Submitted

April 24, 2008

First Submitted That Met QC Criteria

April 24, 2008

First Posted (Estimate)

April 25, 2008

Study Record Updates

Last Update Posted (Estimate)

September 29, 2015

Last Update Submitted That Met QC Criteria

September 28, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CASE3107 (Other Identifier: Case Comprehensive Cancer Center)
  • P30CA043703 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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