Menopausal Symptoms in Women With Breast Cancer or At High Risk of Breast Cancer Treated on Another Clinical Trial
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
-
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Ohio
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Cleveland, Ohio, Forenede Stater, 44106
- Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Retrieval and analysis of data regarding the frequency and intensity of hot flashes
Tidsramme: Up to one year
|
Data from an archived database of a closed clinical trial is retrieved.
|
Up to one year
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Assessment of psychosocial and quality of life scales (i.e., FACT-B and POMS)
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CASE3107 (Anden identifikator: Case Comprehensive Cancer Center)
- P30CA043703 (U.S. NIH-bevilling/kontrakt)
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