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Menopausal Symptoms in Women With Breast Cancer


N/A
18 Years
N/A
Not Enrolling
Female
Breast Cancer, Hot Flashes

Thank you

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.

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

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

Retrieval and analysis of data regarding the frequency and intensity of hot flashes

Outcome Description:

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

Safety Issue:

No

Principal Investigator

Lois C. Friedman, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CASE3107

NCT ID:

NCT00666913

Start Date:

October 2007

Completion Date:

June 2010

Related Keywords:

  • Breast Cancer
  • Hot Flashes
  • 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
  • Breast Neoplasms
  • Hot Flashes

Name

Location

Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer CenterCleveland, Ohio  44106-5065