|Grant Number:||5R01CA140481-04 Interpret this number|
|Primary Investigator:||Maly, Rose|
|Organization:||University Of California Los Angeles|
|Project Title:||Survivorship Plans and Outcomes in Underserved Breast Cancer Survivors|
DESCRIPTION (provided by applicant): Improvements in early detection and successful treatment of breast cancer have lead to a steady rise in the number of breast cancer (BC) survivors. With so many individuals living for extended periods of time with BC as a chronic disease, the Institute of Medicine (IOM) recommends the implementation of treatment summary and survivorship care plans (TSSPs) as a mechanism to improve ongoing clinical and coordination of care, and to address the immediate post-treatment and long-term effects of cancer treatment, including the ongoing psychosocial burden of a cancer diagnosis, as well as the potential for later sequelae of treatment. The need for TSSPs has also been strongly advocated by the American Society of Clinical Oncology's Quality Oncology Practice Initiative and TSSPs have been included in the recently introduced Comprehensive Cancer Improvement Act of 2009 (H.R. 1844). Though the IOM recommended that research should be undertaken to evaluate the impact and costs of TSSPs, there have been no randomized control trials which test the efficacy of TSSPs of which we are aware. At the same time, there is also an increase in the numbers of medically underserved women with BC in the U.S. who may experience burdens accessing medical care and poorer outcomes after treatment. Little is known about survivorship care issues facing underserved women. In the proposed study, we will recruit 400 low income, medically underserved women from two county public hospitals, LAC+USC Medical Center and Harbor-UCLA Medical Center, 18 months after breast cancer diagnosis for participation in a randomized control trial (RCT) designed to test the efficacy of TSSPs. The intervention will be delivered after collection of pre-intervention measures. We will consent and randomize these women into one of two groups: 1) a control condition of usual medical care and 2) an experimental condition of usual medical care + tailored materials which includes the TSSP + 1 face-to-face nurse counseling session, with all cancer specialists and primary care physicians of record also receiving the TSSP and a cover letter suggesting how they are to be clinically utilized. Our specific aims are to assess and compare between experimental and control groups the following primary outcomes at one year post-intervention: 1) discussion and implementation of recommended breast cancer survivorship care, including surveillance and the evaluation and management of BC treatment-related symptoms, 2) patient satisfaction with survivorship communication and care, 3) health-related quality of life, and further, to then 4) assess the cost-effectiveness of the intervention. This study will provide a unique opportunity to assess the efficacy of a tailored treatment summary and survivorship care plan in a low-income, underserved population of BC survivors known to be at high risk for poorer long-term outcomes, including in mental health, quality of life, recurrence and mortality, and will therefore allow us to demonstrate the greatest possible effect size of such an intervention.