Menstrual Cycle Maintenance and Quality of Life: A Prospective Study

N/AActive Not RecruitingNCT00589654

Memorial Sloan Kettering Cancer Center810 enrolled

Overview

Very little is known about the incidence, onset, time course, and symptomatology of premature menopause induced by breast cancer therapy. No prospective study exists. The purpose of the present study is to identify determinants of treatment-related amenorrhea nad its effect on quality of life in a cohort of youg breast cancer patients.

Study Type

OBSERVATIONAL

Enrollment

810

Conditions

Amenorrhea Menstrual Cycle Breast Cancer

Interventions

QuestionnaireOTHER

Data collection instruments will be obtained at baseline and every six months. Follow-up will range between 26-42 months for participants.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Non-institutional (community dwelling) woman of any race * Between 18-45 years at the first screening visit * Have regular menstrual cycles * Diagnosed with invasive breast cancer stage I, II, III within the previous eight months * Have physician agreement for patient participation Exclusion Criteria: * No menstrual bleeding cycles * Psychiatric or psychologic abnormality precluding the informed consent process or which would decrease compliance * Previous malignancy (excepting basal and squamous skin cancer and stage 0 cervical cancer) * Stage IV breast malignancy * Residency outside United States * No telephone

Locations (1)

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Outcomes

Primary Outcomes

The overall goal of the proposed research is to recruit and follow young breast cancer patients aged 45 and younger, in order to examine menstrual cycle maintenance.

Time frame: Conclusion of the study

Secondary Outcomes

Examine possible predictors of treatment-related amenorrhea including age, smoking history, race, and treatment variables

Time frame: Conclusion of study

Data from ClinicalTrials.gov

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