Abstract OT2-5-02: Randomized trial evaluating a coordinated survivorship care program for early stage breast cancer
Authors: Ruddy KJ , Baker EL , Guo H , Goldstein MJ , Winer EP , Shulman LN , Partridge AH 
Published: August 2014

Abstract
Background: Prior studies suggest that many breast cancer survivors use substantial medical resources but still do not receive all guideline-recommended care. Poorly coordinated care may result in unnecessary visits and testing, and may drive up medical costs without improving outcomes. Data are mixed regarding the ability of survivorship care plans to improve the quality of cancer survivorship care.
Trial Design: Randomized (1:1) 2-arm study of a coordinated survivorship care program (including a breast cancer treatment summary and survivorship care plan shared with the patient and mailed to her providers, as well as phone calls from a patient navigator to the patient every three months for one year) compared with standard follow-up care. Participants are asked to complete a survey at baseline and one year later, and medical record review is performed at the end of a year to collect data on medical care received during the first year of survivorship care. Cost data will be acquired via institutional billing systems.
Specific Aims: To assess the effects of the coordinated survivorship care program compared to standard follow-up care on patients’ receipt of redundant care, receipt of guideline-directed care, and cost of care.
The primary endpoint for the study is:
-The proportion of patients in each group who have 2+ office visits that include breast or chest wall exams (not including by plastic surgeons) within 30 days of each other in the absence of a new breast/chest wall complaint during the year of follow-up.
The secondary endpoints for the study include:
-The proportion of age-appropriate health services (mammograms, gynecologic exams, bone density tests, colon cancer screening, cardiovascular screening) performed for each patient
-The number and cost of imaging, lab, and other tests
-The number of MD/NP visits
-Changes between baseline and 1-year in survey data: Lasry Fear of Recurrence score, anxiety/depression (GHQ-12), quality of life (SF-12), satisfaction with care (PSQ-18), satisfaction with study participation, and understanding of follow-up.
Eligibility Criteria: English-speaking, women age 18 or older with recently diagnosed stage 0-3A breast cancer who are planning to receive follow-up medical oncology care through Dana-Farber Cancer Institute (DFCI), with a primary care provider who uses the same electronic medical record. Patients are excluded if more than 30 days have elapsed since the end of active treatment (EATD, defined as the final breast surgery, chemotherapy, radiation, or visit to decide about one of these, whichever was last, excluding reconstructive surgeries and visits).
Statistical Methods: Descriptive statistics will assess the primary and secondary endpoints. For the primary endpoint, the proportion (95% CI) of patients in each arm who receive 2+ breast/chest wall exams within 30 days during the year following the EATD will be determined. With a sample size of 50 per arm, the maximum width of the 95% CI will be 29%.
Target accrual (met between 1/14/11-4/25/13): 100
Contact information: katieruddy@gmail.com.
Citation Information: Cancer Res 2013;73(24 Suppl): Abstract nr OT2-5-02.