Breast Cancer
Conditions
Keywords
Breast Cancer, Cohort, Young Women, Survivorship, Fertility
Brief 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.
Detailed 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.
Interventions
None listed
Sponsors
Dana-Farber Cancer Institute
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Identify a cohort of young women (age 40 or younger) newly diagnosed with breast cancer | 10 years | Characterize the population of young women at diagnosis and in follow-up regarding disease and psychosocial outcomes (e.g., presentation and disease characteristics including evaluating women with metastatic disease, reported frequency and factors associated with genetic testing, treatment patterns and quality of care, short and long-term side effects, and psychosocial concerns including fertility, sexual functioning, and menopausal issues). |
| Specimen Collection | 10 years | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Identify Predictors of Outcome | 10 years | Ultimately, the investigators aim to develop predictors of outcome and identify areas that may be amenable to intervention for young women with breast cancer. |
Countries
Canada, United States
Contacts
PRINCIPAL_INVESTIGATORJeffrey Peppercorn, MD
Massachusetts General Hospital
PRINCIPAL_INVESTIGATORSteven Come, MD, MPH
Beth Israel Deaconess Medical Center
PRINCIPAL_INVESTIGATORTherese Mulvey, MD
Mass General/North-Shore Cancer Center
PRINCIPAL_INVESTIGATORBlair Ardman, MD
Lowell General Hospital
PRINCIPAL_INVESTIGATORLawrence Blaszkowsky, MD
Newton-Wellesley Hospital
PRINCIPAL_INVESTIGATORFrank G Basile, MD
Cape Cod Hospital
PRINCIPAL_INVESTIGATOREllen Warner, MD
Sunnybrook Health Sciences Centre
PRINCIPAL_INVESTIGATORVirginia Borges, MD
University of Colorado, Denver
PRINCIPAL_INVESTIGATORKathryn Ruddy, MD, MPH
Mayo Clinic
PRINCIPAL_INVESTIGATORKatherina Zabicki Calvillo, MD, FACS
South Shore Hospital
PRINCIPAL_INVESTIGATORJeanna Walsh, MD
Dana-Farber/New Hampshire Oncology-Hematology
PRINCIPAL_INVESTIGATORNatalie Sinclair, MD
DF/BWCC at Milford Regional Medical Center
Outcome results
None listed