Menstrual Cycle Maintenance and Quality of Life: A Prospective Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

810 participants

Study Classification

OBSERVATIONAL

Study Start Date

1997-12-31

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Amenorrhea Menstrual Cycle Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1

Questionnaire

Intervention Type OTHER

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

Interventions

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Questionnaire

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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No