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

NCT00062400 | Completed

• 3 other identifiers: EORTC-10002BIG-3-98IBCSG-29-03
• Study Type: interventional
• Target: 385
• Locations: 15 countries
• Sites: 27

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

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

Interventions

psychosocial assessment and care PROCEDURE

Eligibility Criteria

• Age: Up to 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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

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

Sponsors & Collaborators

• European Organisation for Research and Treatment of Cancer - EORTC: lead
• German Adjuvant Breast Cancer Group: collaborator
• ETOP IBCSG Partners Foundation: collaborator

Study Sites (27)

Institut Jules Bordet

Brussels, 1000, Belgium

Location

Centre Hospitalier Etterbeek Ixelles

Brussels, B-1050, Belgium

Location

CHU Liege - Domaine Universitaire du Sart Tilman

Liège, B-4000, Belgium

Location

Algemeen Ziekenhuis Sint-Augustinus

Wilrijk, 2610, Belgium

Location

Instituto de Radiomedicina

Santiago, 10, Chile

Location

Clinica Alemana

Santiago, 5951, Chile

Location

Hospital Militar

Santiago, Chile

Location

University Hospital Rebro

Zagreb, 41000, Croatia

Location

Klinikum der J.W. Goethe Universitaet

Frankfurt, D-60590, Germany

Location

Universitatsklinikum Heidelberg

Heidelberg, 69115, Germany

Location

Centro di Riferimento Oncologico - Aviano

Aviano, 33081, Italy

Location

Azienda Istituti Ospitalieri

Cremona, 26100, Italy

Location

Ospedale Alessandro Manzoni

Lecco, 23900, Italy

Location

European Institute of Oncology

Milan, 20141, Italy

Location

American University of Beirut Medical Center

Beirut, 113-6044, Lebanon

Location

Academisch Medisch Centrum at University of Amsterdam

Amsterdam, 1105 AZ, Netherlands

Location

Arnhems Radiotherapeutisch Instituut

Arnhem, 6815 AD, Netherlands

Location

Instituto Nacional de Enfermedades Neoplasicas

Lima, 34, Peru

Location

Medical University of Gdansk

Gdansk, 80-211, Poland

Location

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

Lisbon, 1099-023 Codex, Portugal

Location

Institute of Oncology and Radiology of Serbia

Belgrade, 11000, Serbia

Location

Groote Schuur Hospital

Cape Town, 7925, South Africa

Location

Inselspital Bern

Bern, CH-3010, Switzerland

Location

Ospedale Beata Vergine

Mendrisio, CH-6850, Switzerland

Location

Kantonsspital - St. Gallen

Sankt Gallen, CH-9007, Switzerland

Location

Marmara University Hospital

Istanbul, 81190, Turkey (Türkiye)

Location

Western Infirmary

Glasgow, Scotland, G11 6NT, United Kingdom

Location

Related Publications (1)

• 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.

  RESULT

MeSH Terms

Conditions

Breast Neoplasms; Sexual Dysfunction, Physiological; Infertility; Sexuality

Interventions

Psychiatric Rehabilitation

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Genital Diseases; Urogenital Diseases; Sexual Behavior; Behavior

Intervention Hierarchy (Ancestors)

Rehabilitation; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Zora Neskovic-Konstantinovic

  Institute Of Oncology & Radiology, Belgrade, Serbia

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2003
• First Posted: June 6, 2003
• Study Start: May 1, 2003
• Primary Completion: June 1, 2008
• Last Updated: October 24, 2013

Record last verified: 2013-10

Locations

IT (4); CR (1); PT (1); ZA (1); SE (1); CL (3); NL (2); PE (1); BE (4); LE (1); PL (1); CH (3); GB (1); DE (2); TU (1)