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The Young Women's Breast Cancer Study (HOHO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01468246
Recruitment Status : Active, not recruiting
First Posted : November 9, 2011
Last Update Posted : April 3, 2023
Sponsor:
Information provided by (Responsible Party):
Ann H. Partridge, MD, MPH, Dana-Farber Cancer Institute

Tracking Information
First Submitted Date November 5, 2011
First Posted Date November 9, 2011
Last Update Posted Date April 3, 2023
Study Start Date November 2006
Estimated Primary Completion Date November 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 8, 2011)
  • Identify a cohort of young women (age 40 or younger) newly diagnosed with breast cancer [ Time Frame: 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 [ Time Frame: 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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: November 8, 2011)
Identify Predictors of Outcome [ Time Frame: 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Young Women's Breast Cancer Study
Official Title Helping Ourselves, Helping Others: The Young Women's Breast Cancer Study
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
The investigators are collecting blood and tumor specimens.
Sampling Method Non-Probability Sample
Study Population This study includes women who are newly-diagnosed with breast cancer. They must be 40 or younger at their diagnosis.
Condition Breast Cancer
Intervention Not Provided
Study Groups/Cohorts Young Women
Young women with newly diagnosed breast cancer
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: July 25, 2017)
1302
Original Estimated Enrollment
 (submitted: November 8, 2011)
1000
Estimated Study Completion Date January 2026
Estimated Primary Completion Date November 2025   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01468246
Other Study ID Numbers 06-169
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Current Responsible Party Ann H. Partridge, MD, MPH, Dana-Farber Cancer Institute
Original Responsible Party Same as current
Current Study Sponsor Dana-Farber Cancer Institute
Original Study Sponsor Same as current
Collaborators Not Provided
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
PRS Account Dana-Farber Cancer Institute
Verification Date March 2023