Study protocol for Young & Strong: a cluster randomized design to increase attention to unique issues faced by young women with newly diagnosed breast cancer

BMC Public Health

Ann H Partridge⁴  Karen M Emmons²  Meghan Meyer⁵  Emily Baker⁵  William T Barry⁵  Jennifer Ligibel⁴  Kathryn J Ruddy¹  Kim Sprunck-Harrild⁵  Mary L Greaney³ 

[1] Mayo Clinic, Rochester, MN, USA;Harvard School of Public Health, Boston, MA, USA;University of Rhode Island, Kingston 02881, RI, USA;Harvard Medical School, Boston, MA, USA;Dana-Farber Cancer Institute, Boston 02215, MA, USA

关键词: Patient communication;    Psychosocial distress;    Exercise;    Fertility;    Young women;    Oncology;    Breast cancer;   

Others  :  1122830
DOI  :  10.1186/s12889-015-1346-9

 received in 2014-12-20, accepted in 2015-01-02,  发布年份 2015

【 摘 要 】

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/Design

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.

Discussion

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.

Trial registration

NCT01647607 webcite. Registered July 19, 2012.

【 授权许可】

   
2015 Greaney et al.; licensee BioMed Central.

【 图 表 】

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