Menstrual Cycle Maintenance and Quality of Life: A Prospective Study

Sponsor

Memorial Sloan Kettering Cancer Center (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT00589654

Collaborator

(none)

810

Enrollment

Location

312

Duration (Months)

2.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Amenorrhea Menstrual Cycle Breast Cancer	Other: Questionnaire

Study Design

Study Type:

Observational

Anticipated Enrollment :

810 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Menstrual Cycle Maintenance and Quality of Life: A Prospective Study

Study Start Date :

Dec 1, 1997

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
1	Other: Questionnaire Data collection instruments will be obtained at baseline and every six months. Follow-up will range between 26-42 months for participants.

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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