Menopausal Symptoms in Women With Breast Cancer or At Hig... | NCT00666913

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

NCT00666913

Sponsor

Case Comprehensive Cancer Center

Status

Completed

Last Update Posted

Sep 29, 2015Estimated

Enrollment

183Actual

Phase

Not provided

Conditions

Breast Cancer
Hot Flashes

Interventions

informational intervention

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
P30CA043703	U.S. NIH Grant/Contract		View source
CASE3107	Other Identifier	Case Comprehensive Cancer Center

Status Module

Record Verification Date

Sep 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2007

Primary Completion Date

Jun 2010Actual

Completion Date

Jun 2010Actual

First Submitted Date

Apr 24, 2008

First Submission Date that Met QC Criteria

Apr 24, 2008

First Posted Date

Apr 25, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 28, 2015

Last Update Posted Date

Sep 29, 2015Estimated

Name	Class
National Cancer Institute (NCI)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

183Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
informational intervention	Other	Data from an archived database of a closed clinical trial is retrieved.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Assessment of psychosocial and quality of life scales (i.e., FACT-B and POMS)	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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Lois C. Friedman, PhD	Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center		Cleveland	Ohio	44106	United States

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms
D019584	Hot Flashes
D000071960	Breast Carcinoma In Situ

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided