The Young Women's Breast Cancer Study (HOHO)
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Purpose
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.
| Condition |
|---|
|
Breast Cancer |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Helping Ourselves, Helping Others: The Young Women's Breast Cancer Study |
- Identify a cohort of young women (age 40 or younger) newly diagnosed with breast cancer [ Time Frame: 10 years ] [ Designated as safety issue: No ]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 [ Time Frame: 10 years ] [ Designated as safety issue: No ]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.
- Identify Predictors of Outcome [ Time Frame: 10 years ] [ Designated as safety issue: No ]Ultimately, the investigators aim to develop predictors of outcome and identify areas that may be amenable to intervention for young women with breast cancer.
Biospecimen Retention: Samples With DNA
The investigators are collecting blood and tumor specimens.
| Estimated Enrollment: | 1000 |
| Study Start Date: | November 2006 |
| Estimated Study Completion Date: | January 2026 |
| Estimated Primary Completion Date: | November 2025 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Young Women
Young women with newly diagnosed 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 1,300 women age 40 and younger with newly diagnosed breast cancer from academic and community health care institutions. It is anticipated that 1,000 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| Ages Eligible for Study: | 18 Years to 40 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
This study includes women who are newly-diagnosed with breast cancer. They must be 40 or younger at their diagnosis.
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
Contacts and Locations| Contact: Ann H Partridge, MD, MPH | 617-632-3800 | ahpartridge@partners.org |
| United States, Colorado | |
| University of Colorado Cancer Center | Recruiting |
| Aurora, Colorado, United States, 80045 | |
| Contact: Elizabeth Manthey, BS 303-266-1375 ELIZABETH.MANTHEY@UCDENVER.EDU | |
| Principal Investigator: Virginia Borges, MD | |
| United States, Massachusetts | |
| Dana-Farber Cancer Institute | Recruiting |
| Boston, Massachusetts, United States, 02215 | |
| Contact: Meghan E Meyer, BS 617-632-4983 mmeyer1@partners.org | |
| Contact: Sandra Kereakoglow, BA 617-582-7641 skereakoglow@partners.org | |
| Principal Investigator: Ann H Partridge, MD, MPH | |
| Massachusetts General Hospital | Recruiting |
| Boston, Massachusetts, United States, 02215 | |
| Contact: Nancy Naam, BS 617-724-1079 nnaam@partners.org | |
| Principal Investigator: Lidia Schapira, MD | |
| Beth-Israel Deaconess Medical Center | Recruiting |
| Boston, Massachusetts, United States, 02215 | |
| Contact: Kathyrn P Componeschi, BA 617-667-3347 kcompone@bidmc.harvard.edu | |
| Principal Investigator: Steven Come, MD | |
| Cape Cod Hospital | Recruiting |
| Hyannis, Massachusetts, United States, 02601 | |
| Contact: Rebecca Buscanera, RN 508-862-5799 rbuscanera@capecodhealth.org | |
| Principal Investigator: Kelly Swanson, DO | |
| Lowell General Hospital | Recruiting |
| Lowell, Massachusetts, United States, 01854 | |
| Contact: Gayle Hincks, RN 978-788-7084 ghincks@LowellGeneral.org | |
| Principal Investigator: Blair Ardman, MD | |
| Newton-Wellesley Hospital | Recruiting |
| Newton, Massachusetts, United States, 02462 | |
| Contact: Judith Chow 617-243-6392 jgchow@partners.org | |
| Principal Investigator: Caroline Block, MD | |
| Canada, Ontario | |
| Sunnybrook Health Sciences Centre | Recruiting |
| Toronto, Ontario, Canada, 3M5 | |
| Contact: Rodica Mandel, BS 416-480-4065 Rodica.Mandel@sunnybrook.ca | |
| Principal Investigator: Ellen Warner, MD | |
| Principal Investigator: | Lidia Schapira, MD | Massachusetts General Hospital |
| Principal Investigator: | Steven Come, MD, MPH | Beth Israel Deaconess Medical Center |
| Principal Investigator: | Karen Krag, MD | Mass General/North-Shore Cancer Center |
| Principal Investigator: | Blair Ardman, MD | Lowell General Hospital |
| Principal Investigator: | Caroline Block, MD | Newton-Wellesley Hospital |
| Principal Investigator: | Kelly Swanson, DO | Cape Cod Healthcare |
| Principal Investigator: | Ellen Warner, MD | Sunnybrook Health Sciences Centre |
| Principal Investigator: | Virginia Borges, MD | University of Colorado, Denver |
More Information
No publications provided
| Responsible Party: | Ann H. Partridge, MD, MPH, Principal Investigator, Dana-Farber Cancer Institute |
| ClinicalTrials.gov Identifier: | NCT01468246 History of Changes |
| Other Study ID Numbers: | 06-169 |
| Study First Received: | November 5, 2011 |
| Last Updated: | September 11, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Dana-Farber Cancer Institute:
|
Breast Cancer Cohort Young Women Survivorship Fertility |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
ClinicalTrials.gov processed this record on June 13, 2013