title: Study protocol for Young & Strong: a cluster randomized design to increase attention to unique issues faced by young women with newly diagnosed breast cancer.
abstract: BACKGROUND
  Each year, approximately 11% of women diagnosed with breast cancer in the United States are 45 years of age or younger. These women have concerns specific to or accentuated by their age, including fertility-related concerns, and have higher rates of psychosocial distress than women diagnosed at older ages. Current guidelines recommend that fertility risks be considered early in all treatment plans; however, the extant research indicates that attention to fertility by the healthcare team is limited. Importantly, attention to fertility may be a proxy for whether or not other important issues warranting attention in younger women with breast cancer are addressed, including genetic risks, psychosocial distress, sexual functioning, and body image concerns. The Young & Strong study tests the efficacy of an intervention designed for young women recently diagnosed with breast cancer and their oncologists with the intention to: 1) increase attention to fertility as an important surrogate for other issues facing young women, 2) educate and support young women and their providers, and 3) reduce psychosocial distress among young women with breast cancer.
  
  
  METHODS
  The study employs a cluster randomized design including 14 academic institutions and 40 community sites across the U.S. assigned to either the study intervention arm or contact-time comparison intervention arm. Academic institutions enroll up to 15 patients per site while community sites enroll up to 10 patients. Patient eligibility requirements include: an initial diagnosis of stage I-III invasive breast cancer within three months prior, without a known recurrence or metastatic breast cancer; 18-45 years of age at diagnosis; ability to read and write in English. The primary outcome is oncologists' attention to fertility concerns as determined by medical record review. Secondary outcomes include differences in patient satisfaction with care and psychosocial distress between the two study arms.
  
  
  CONCLUSIONS
  Study findings will provide valuable insight into how to increase attention to fertility and other issues specific to young women with breast cancer and how to improve doctor-patient communication around these issues, which may promote better quality of care for this population.
  
  
  BACKGROUND
  NCT01647607. Registered July 19, 2012.
authors: University of Rhode Island, Kingston, RI, 02881, USA. mgreaney@uri.edu.
authors: Mary L
authors: ML
authors: Greaney
authors: Dana-Farber Cancer Institute, Boston, MA, 02215, USA. kim_sprunckharrild@dfci.harvard.edu.
authors: Kim
authors: K
authors: Sprunck-Harrild
authors: Mayo Clinic, Rochester, MN, USA. ruddy.kathryn@mayo.edu.
authors: Kathryn J
authors: KJ
authors: Ruddy
authors: Dana-Farber Cancer Institute, Boston, MA, 02215, USA. Jennifer_Ligibel@dfci.harvard.edu.|Harvard Medical School, Boston, MA, USA. Jennifer_Ligibel@dfci.harvard.edu.
authors: Jennifer
authors: J
authors: Ligibel
authors: Dana-Farber Cancer Institute, Boston, MA, 02215, USA. bbarry@jimmy.harvard.edu.
authors: William T
authors: WT
authors: Barry
authors: Dana-Farber Cancer Institute, Boston, MA, 02215, USA. EmilyL_Baker@dfci.harvard.edu.
authors: Emily
authors: E
authors: Baker
authors: Dana-Farber Cancer Institute, Boston, MA, 02215, USA. Meghan_Meyer@dfci.harvard.edu.
authors: Meghan
authors: M
authors: Meyer
authors: Harvard School of Public Health, Boston, MA, USA. karen.m.emmons@kp.org.
authors: Karen M
authors: KM
authors: Emmons
authors: Dana-Farber Cancer Institute, Boston, MA, 02215, USA. Ann_Partridge@dfci.harvard.edu.|Harvard Medical School, Boston, MA, USA. Ann_Partridge@dfci.harvard.edu.
authors: Ann H
authors: AH
authors: Partridge
mesh_terms: D000223:Adaptation, Psychological; D000328:Adult; D000367:Age Factors; D001943:Breast Neoplasms / Q000175:diagnosis / Q000523:psychology*; D005260:Female; D015438:Health Behavior; D006801:Humans; D017060:Patient Satisfaction; D011788:Quality of Life / Q000523:psychology*; D012107:Research Design; D014481:United States; D016387:Women's Health; D055815:Young Adult
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