Breast Cancer Clinical Trial
The Young Women’s Breast Cancer Study
Summary
The investigators are conducting a longitudinal cohort study of young women with breast cancer. The investigators identify women age 40 and younger with newly-diagnosed breast cancer from academic and community healthcare institutions. After women consent to the study, they fill-out surveys and give blood samples, and the investigators collect tissue from their breast cancer tumor after it is removed. Women are surveyed every 6 months for the first 3 years after diagnosis, then yearly thereafter for an additional 7 years (for a total follow-up of at least 10 years following diagnosis). The study investigates short and long-term disease and treatment issues, tumor biology and the relationship to patient outcomes, and psychosocial concerns at baseline and in follow-up among a cohort of young women who are newly-diagnosed with breast cancer.
Full Description
This is a longitudinal cohort study of young women with breast cancer. Over a 6-year period, the investigators aim to identify over 1,600 women age 40 and younger with newly diagnosed breast cancer from academic and community health care institutions. It is anticipated that 1,300 of these women will agree to participate in an observational study. Patient surveys, medical record review, and blood and tissue collection will be utilized. Women will be surveyed every 6 months for the first 3 years after diagnosis, then yearly thereafter for an additional 7 years (for a total follow-up of 10 year following diagnosis). The study will investigate short and long-term disease and treatment issues, and psychosocial concerns at baseline and in follow-up among a cohort of young women (age 40 or younger) newly diagnosed with breast cancer. The investigators aim to characterize the population of young women at diagnosis and in follow-up regarding disease and psychosocial outcomes (e.g., presentation and disease characteristics, treatment patterns and quality of care, short and long-term side effects, and psychosocial concerns including fertility, sexual functioning, and menopausal issues). The investigators will also collect tumor and blood specimens to characterize the tumors, and bank for future studies including molecular evaluations of disease characteristics, genetic variability and hormonal levels in blood. Ultimately, the investigators aim to develop predictors of outcome, and identify areas that may be amenable to intervention.
Eligibility Criteria
Inclusion Criteria:
Female
Diagnosis of breast cancer
Age 40 or younger at diagnosis
Informed consent obtained from patient
Ability to understand written and spoken English to the extent necessary to complete the questionnaires
Exclusion Criteria:
Inability to understand written and spoken English to the extent necessary to complete the questionnaires
Absence of informed consent
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There are 11 Locations for this study
Aurora Colorado, 80045, United States
Boston Massachusetts, 02215, United States
Boston Massachusetts, 02215, United States
Boston Massachusetts, 02215, United States
Danvers Massachusetts, 01923, United States
Hyannis Massachusetts, 02601, United States
Lowell Massachusetts, 01854, United States
Milford Massachusetts, 01757, United States
Newton Massachusetts, 02462, United States
South Weymouth Massachusetts, 02190, United States
Rochester Minnesota, 55905, United States
Londonderry New Hampshire, 03053, United States
Toronto Ontario, 3M5, Canada
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