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

NCT00666913 | Completed

• 2 other identifiers: CASE3107P30CA043703
• Study Type: observational
• Target: 183
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Hot Flashes

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 (1)

• Assessment of psychosocial and quality of life scales (i.e., FACT-B and POMS)

  Up to one year

Interventions

informational intervention OTHER

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

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

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

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Hot Flashes; Breast Carcinoma In Situ

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Carcinoma in Situ; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Lois C. Friedman, PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2008
• First Posted: April 25, 2008
• Study Start: October 1, 2007
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: September 29, 2015

Record last verified: 2015-09

Locations

US (1)