Menstrual Cycle Maintenance and Quality of Life: A Prospective Study
Active, not recruiting
- Conditions
- Breast CancerMenstrual CycleAmenorrhea
- Interventions
- Other: Questionnaire
- Registration Number
- NCT00589654
- Lead Sponsor
- Memorial Sloan Kettering Cancer Center
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 810
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
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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
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Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description 1 Questionnaire -
- Primary Outcome Measures
Name Time Method 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. Conclusion of the study
- Secondary Outcome Measures
Name Time Method Examine possible predictors of treatment-related amenorrhea including age, smoking history, race, and treatment variables Conclusion of study
Trial Locations
- Locations (1)
Memorial Sloan Kettering Cancer Center
🇺🇸New York, New York, United States