HOHO: The Young Women's Breast Cancer Study

Sponsor

Dana-Farber Cancer Institute (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT01468246

Collaborator

(none)

1,302

Enrollment

Locations

230

Duration (Months)

100.2

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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.

Study Design

Study Type:

Observational

Actual Enrollment :

1302 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Nov 1, 2006

Anticipated Primary Completion Date :

Nov 1, 2025

Anticipated Study Completion Date :

Jan 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Young Women Young women with newly diagnosed breast cancer

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	University of Colorado Cancer Center	Aurora	Colorado	United States	80045
2	Beth-Israel Deaconess Medical Center	Boston	Massachusetts	United States	02215
3	Dana-Farber Cancer Institute	Boston	Massachusetts	United States	02215
4	Massachusetts General Hospital	Boston	Massachusetts	United States	02215
5	MGH/North Shore Cancer Center	Danvers	Massachusetts	United States	01923
6	Cape Cod Hospital	Hyannis	Massachusetts	United States	02601
7	Lowell General Hospital	Lowell	Massachusetts	United States	01854
8	DF/BWCC at Milford Regional Medical Center	Milford	Massachusetts	United States	01757
9	Newton-Wellesley Hospital	Newton	Massachusetts	United States	02462
10	South Shore Hospital	South Weymouth	Massachusetts	United States	02190
11	Mayo Clinic	Rochester	Minnesota	United States	55905
12	Dana-Farber/New Hampshire Oncology-Hematology	Londonderry	New Hampshire	United States	03053
13	Sunnybrook Health Sciences Centre	Toronto	Ontario	Canada	3M5

Sponsors and Collaborators

Dana-Farber Cancer Institute

Investigators

Principal Investigator: Jeffrey Peppercorn, MD, Massachusetts General Hospital
Principal Investigator: Steven Come, MD, MPH, Beth Israel Deaconess Medical Center
Principal Investigator: Therese Mulvey, MD, Mass General/North-Shore Cancer Center
Principal Investigator: Blair Ardman, MD, Lowell General Hospital
Principal Investigator: Lawrence Blaszkowsky, MD, Newton-Wellesley Hospital
Principal Investigator: Frank G Basile, MD, Cape Cod Hospital
Principal Investigator: Ellen Warner, MD, Sunnybrook Health Sciences Centre
Principal Investigator: Virginia Borges, MD, University of Colorado, Denver
Principal Investigator: Kathryn Ruddy, MD, MPH, Mayo Clinic
Principal Investigator: Katherina Zabicki Calvillo, MD, FACS, South Shore Hospital
Principal Investigator: Jeanna Walsh, MD, Dana-Farber/New Hampshire Oncology-Hematology
Principal Investigator: Natalie Sinclair, MD, DF/BWCC at Milford Regional Medical Center