Menstrual Cycle Maintenance and Quality of Life: A Prospective Study (NCT00589654) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Menstrual Cycle Maintenance and Quality of Life: A Prospective Study
United States810 participantsStarted 1997-12
Plain-language 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.
Who can participate
Age range
18 Years – 45 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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.