Study of Survivorship Care Plans and Outcomes in Underserved Breast Cancer Survivors
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 after diagnosis, the Institute of Medicine (IOM) recommends the implementation of treatment summaries 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. 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 (H.R. 1844). This will be one of the first randomized controlled trials to test the efficacy of TSSPs.
The investigators will recruit 500 low income, medically underserved women from two county public hospitals, LAC+USC Medical Center and Harbor-UCLA Medical Center, 12 months after breast cancer diagnosis for participation in a randomized controlled trial (RCT) designed to test the efficacy of TSSPs. The investigators will randomize these women into one of two groups: 1) a control condition of usual medical care and 2) an experimental condition of the control condition + a tailored 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 can be clinically utilized.
The investigators 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) pertinent aspects of health-related quality of life, and further, to then 4) assess the cost-consequences of the experimental intervention. This study will provide a unique opportunity to assess the efficacy of TSSPs 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 benefit of such an intervention.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
|Official Title:||Survivorship Plans and Outcomes in Underserved Breast Cancer Survivors RCT|
- Provider Adherence Score (PAS) [ Time Frame: One year post-intervention ] [ Designated as safety issue: No ]Discussion and implementation of recommended breast cancer (BC) survivorship care, including surveillance and the evaluation and management of BC treatment-related symptoms, bone health, weight, vasomotor symptoms, mammography, clinical breast examinations, and depression, as well as discussion of the patient's primary BC-related concern.
- Patient satisfaction [ Time Frame: One year post-invervention ] [ Designated as safety issue: No ]Patient satisfaction with survivorship communication and care.
- Quality of life [ Time Frame: One year post-intervention ] [ Designated as safety issue: No ]Health-related quality of life
- Cost-consequence analysis [ Time Frame: One year post-intervention ] [ Designated as safety issue: No ]Assess the immediate cost of the intervention itself, the downstream costs specifically related to health-care utilization from the survivorship care plan recommendations, and the resulting health benefits, in a cost consequence analysis.
|Study Start Date:||August 2012|
|Estimated Study Completion Date:||September 2015|
|Estimated Primary Completion Date:||August 2015 (Final data collection date for primary outcome measure)|
|Experimental: Survivorship Care Plan||
Other: Survivorship Care Plan
Receipt of a personalized survivorship care plan and an in-person session with a trained nurse to review the contents of the care plan.
Other Name: Treatment Summary and Survivorship Care Plans
|No Intervention: Usual care||
Other: Usual care
Receipt of usual medical care
Please refer to this study by its ClinicalTrials.gov identifier: NCT01627366
|Contact: Jeanette Gibbon, MPHfirstname.lastname@example.org|
|Contact: Shannon Jason, MSPHemail@example.com|
|United States, California|
|UCLA||Not yet recruiting|
|Los Angeles, California, United States, 90024|
|Contact: Jeanette Gibbon, MPH|
|Principal Investigator: Rose C Maly, MD, MSPH|
|Principal Investigator:||Rose C Maly, MD, MSPH||University of California, Los Angeles|