Assessing Women's Attitudes About the Risk of Infertility Related to Adjuvant Therapy for Early Breast Cancer - Tabular View

Tracking Information

First Received Date ^ICMJE

June 5, 2003

Last Updated Date

July 14, 2009

Start Date ^ICMJE

May 2003

Estimated Primary Completion Date

March 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Patients who would agree to have chemotherapy if it reduces their chances of having children as assessed by questionnaire [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Patients who would agree to have chemotherapy if it reduces their chances of having children as assessed by questionnaire

Change History

Complete list of historical versions of study NCT00062400 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Assessing Women's Attitudes About the Risk of Infertility Related to Adjuvant Therapy for Early Breast Cancer

Official Title ^ICMJE

A Survey of the Breast International Group (B.I.G.) to Assess the Attitude of Patients Aged Less Than 35 Years, With Early Breast Cancer, Toward the Risk of Loss of Fertility Related to Adjuvant Therapies

Brief Summary

RATIONALE: Adjuvant therapy given after surgery for early breast cancer may cause infertility. Assessing young women's attitudes and feelings about the risk of infertility may help improve the ability to plan effective treatment.

PURPOSE: This clinical trial is studying young women's attitudes and feelings about the risk of infertility related to adjuvant therapy for stage I or stage II breast cancer.

Detailed Description

OBJECTIVES:

Determine the attitude toward the risk of infertility related to adjuvant therapy in women with early breast cancer.
Correlate, if possible, the patient's attitude with the fact that the patient already has children or the time interval between the date of breast cancer diagnosis and the date of study participation.

OUTLINE: This is a multicenter study.

Patients complete a questionnaire administered by a nontreating physician.

PROJECTED ACCRUAL: A total of 385 patients will be accrued for this study.

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Other

Condition ^ICMJE

Breast Cancer
Psychosocial Effects of Cancer and Its Treatment
Sexual Dysfunction and Infertility
Sexuality and Reproductive Issues

Intervention ^ICMJE

Procedure: psychosocial assessment and care

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

385

Completion Date

Estimated Primary Completion Date

March 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

DISEASE CHARACTERISTICS:

Histologically or cytologically confirmed prior or current diagnosis of breast cancer
- Stage I or II
- No relapsed disease
No evidence of infertility
- Regular menses or regular hormonal contraception use for the past 3 months
Hormonal status:
- Not specified

PATIENT CHARACTERISTICS:

Age

35 and under at diagnosis

Sex

Female

Menopausal status

Premenopausal

Performance status

Not specified

Life expectancy

Not specified

Hematopoietic

Not specified

Hepatic

Not specified

Renal

Not specified

Other

No psychological, familial, sociological, or geographical condition that would preclude study compliance

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

Not specified

Endocrine therapy

See Disease Characteristics

Radiotherapy

Not specified

Surgery

Not specified

Gender

Female

Ages

up to 35 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Location Countries ^ICMJE

Belgium, Chile, Croatia, Germany, Italy, Lebanon, Netherlands, Peru, Poland, Portugal, Serbia, South Africa, Switzerland, Turkey, United Kingdom

Administrative Information

NCT ID ^ICMJE

NCT00062400

Responsible Party

Study ID Numbers ^ICMJE

CDR0000304757, EORTC-10002, BIG-3-98

Study Sponsor ^ICMJE

European Organization for Research and Treatment of Cancer

Collaborators ^ICMJE

Investigators ^ICMJE

Investigator:

Angelo Di Leo, MD

Misericordia e Dolce Hospital

Information Provided By

National Cancer Institute (NCI)

Verification Date

June 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP