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Helping Ourselves, Helping Others: The Young Women's Breast Cancer Study


N/A
18 Years
40 Years
Open (Enrolling)
Female
Breast Cancer

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Trial Information

Helping Ourselves, Helping Others: The Young Women's Breast Cancer Study


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.


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

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Identify a cohort of young women (age 40 or younger) newly diagnosed with breast cancer

Outcome Description:

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).

Outcome Time Frame:

10 years

Safety Issue:

No

Principal Investigator

Lidia Schapira, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massachusetts General Hospital

Authority:

United States: Institutional Review Board

Study ID:

06-169

NCT ID:

NCT01468246

Start Date:

November 2006

Completion Date:

January 2026

Related Keywords:

  • Breast Cancer
  • Breast Cancer
  • Cohort
  • Young Women
  • Survivorship
  • Fertility
  • Breast Neoplasms

Name

Location

University of Colorado Cancer CenterDenver, Colorado  80262
Cape Cod HospitalHyannis, Massachusetts  02601
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Massachusetts General HospitalBoston, Massachusetts  02114-2617
Lowell General HospitalLowell, Massachusetts  01854
Newton-Wellesley HospitalNewton, Massachusetts  02462
Beth-Israel Deaconess Medical CenterBoston, Massachusetts