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

Primary Purpose

Breast Cancer, Psychosocial Effects of Cancer and Its Treatment, Sexual Dysfunction and Infertility

Status

Completed

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

psychosocial assessment and care

About this trial

This is an interventional trial for Breast Cancer focused on measuring sexual dysfunction and infertility, sexuality and reproductive issues, psychosocial effects of cancer and its treatment, stage II breast cancer, stage IA breast cancer, stage IB breast cancer

Eligibility Criteria

undefined - 35 Years (Child, Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Institut Jules Bordet
Centre Hospitalier Etterbeek Ixelles
CHU Liege - Domaine Universitaire du Sart Tilman
Algemeen Ziekenhuis Sint-Augustinus
Instituto de Radiomedicina
Clinica Alemana
Hospital Militar
University Hospital Rebro
Klinikum der J.W. Goethe Universitaet
Universitatsklinikum Heidelberg
Centro di Riferimento Oncologico - Aviano
Azienda Istituti Ospitalieri
Ospedale Alessandro Manzoni
European Institute of Oncology
American University of Beirut Medical Center
Academisch Medisch Centrum at University of Amsterdam
Arnhems Radiotherapeutisch Instituut
Instituto Nacional de Enfermedades Neoplasicas
Medical University of Gdansk
Instituto Portugues de Oncologia de Francisco Gentil - Centro Regional de Oncologia de Lisboa, SA
Institute of Oncology and Radiology of Serbia
Groote Schuur Hospital
Inselspital Bern
Ospedale Beata Vergine
Kantonsspital - St. Gallen
Marmara University Hospital
Western Infirmary

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT00062400

First Posted

June 5, 2003

Last Updated

October 23, 2013

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Collaborators

German Adjuvant Breast Cancer Group, ETOP IBCSG Partners Foundation

1. Study Identification

Unique Protocol Identification Number

NCT00062400

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2013

Overall Recruitment Status

Completed

Study Start Date

May 2003 (undefined)

Primary Completion Date

June 2008 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Collaborators

German Adjuvant Breast Cancer Group, ETOP IBCSG Partners Foundation

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

sexual dysfunction and infertility, sexuality and reproductive issues, psychosocial effects of cancer and its treatment, stage II breast cancer, stage IA breast cancer, stage IB breast cancer

7. Study Design

Study Phase

Not Applicable

Enrollment

385 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

psychosocial assessment and care

Primary Outcome Measure Information:

Title

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

10. Eligibility

Sex

Female

Maximum Age & Unit of Time

35 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Zora Neskovic-Konstantinovic

Organizational Affiliation

Institute Of Oncology & Radiology, Belgrade, Serbia

Official's Role

Study Chair

Facility Information:

Facility Name

Institut Jules Bordet

City

Brussels

ZIP/Postal Code

1000

Country

Belgium

Facility Name

Centre Hospitalier Etterbeek Ixelles

City

Brussels

ZIP/Postal Code

B-1050

Country

Belgium

Facility Name

CHU Liege - Domaine Universitaire du Sart Tilman

City

Liege

ZIP/Postal Code

B-4000

Country

Belgium

Facility Name

Algemeen Ziekenhuis Sint-Augustinus

City

Wilrijk

ZIP/Postal Code

2610

Country

Belgium

Facility Name

Instituto de Radiomedicina

City

Santiago

ZIP/Postal Code

Country

Chile

Facility Name

Clinica Alemana

City

Santiago

ZIP/Postal Code

5951

Country

Chile

Facility Name

Hospital Militar

City

Santiago

Country

Chile

Facility Name

University Hospital Rebro

City

Zagreb

ZIP/Postal Code

41000

Country

Croatia

Facility Name

Klinikum der J.W. Goethe Universitaet

City

Frankfurt

ZIP/Postal Code

D-60590

Country

Germany

Facility Name

Universitatsklinikum Heidelberg

City

Heidelberg

ZIP/Postal Code

69115

Country

Germany

Facility Name

Centro di Riferimento Oncologico - Aviano

City

Aviano

ZIP/Postal Code

33081

Country

Italy

Facility Name

Azienda Istituti Ospitalieri

City

Cremona

ZIP/Postal Code

26100

Country

Italy

Facility Name

Ospedale Alessandro Manzoni

City

Lecco

ZIP/Postal Code

23900

Country

Italy

Facility Name

European Institute of Oncology

City

Milan

ZIP/Postal Code

20141

Country

Italy

Facility Name

American University of Beirut Medical Center

City

Beirut

ZIP/Postal Code

113-6044

Country

Lebanon

Facility Name

Academisch Medisch Centrum at University of Amsterdam

City

Amsterdam

ZIP/Postal Code

1105 AZ

Country

Netherlands

Facility Name

Arnhems Radiotherapeutisch Instituut

City

Arnhem

ZIP/Postal Code

6815 AD

Country

Netherlands

Facility Name

Instituto Nacional de Enfermedades Neoplasicas

City

Lima

ZIP/Postal Code

Country

Peru

Facility Name

Medical University of Gdansk

City

Gdansk

ZIP/Postal Code

80-211

Country

Poland

Facility Name

Instituto Portugues de Oncologia de Francisco Gentil - Centro Regional de Oncologia de Lisboa, SA

City

Lisboa

ZIP/Postal Code

1099-023 Codex

Country

Portugal

Facility Name

Institute of Oncology and Radiology of Serbia

City

Belgrade

ZIP/Postal Code

11000

Country

Serbia

Facility Name

Groote Schuur Hospital

City

Cape Town

ZIP/Postal Code

7925

Country

South Africa

Facility Name

Inselspital Bern

City

Bern

ZIP/Postal Code

CH-3010

Country

Switzerland

Facility Name

Ospedale Beata Vergine

City

Mendrisio

ZIP/Postal Code

CH-6850

Country

Switzerland

Facility Name

Kantonsspital - St. Gallen

City

St. Gallen

ZIP/Postal Code

CH-9007

Country

Switzerland

Facility Name

Marmara University Hospital

City

Istanbul

ZIP/Postal Code

81190

Country

Turkey

Facility Name

Western Infirmary

City

Glasgow

State/Province

Scotland

ZIP/Postal Code

G11 6NT

Country

United Kingdom

12. IPD Sharing Statement

Citations:

Citation

Neskovic-Konstantinovic Z, Gomez H, Senkus-Konefka E, et al.: A Breast International Group survey of young breast cancer patients attitudes towards the risk of loss of fertility related to adjuvant therapies: EORTC protocol 10002 - BIG 3-98. [Abstract] 31st Annual San Antonio Breast Cancer Symposium, December 10-14, 2008, San Antonio, Texas. A-3106, 2008.

Results Reference

result

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

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