CanSORT received a $13.7 million dollar P01 Program Project Award from the NCI in 2012 to lead research addressing the challenges of individualizing treatments for patients with early-stage breast cancer. The program aims to examine the challenges of individualizing treatments for breast cancer; improve decision quality for patients with breast cancer; accelerate the dissemination of SEER-based research findings to clinicians in the region; and advance methods in SEER population translational research focused on quality of care. Three individual projects are included in this program.
Two program projects utilize population-based, observational methods in 4600 patients, newly diagnosed with breast cancer, and their clinicians to examine patient and clinician factors associated with evaluative tests, treatments, and decision quality. Project 1 focuses on challenges that surgeons and their patients face during evaluation and management of locoregional therapies. Project 2 focuses on challenges that medical oncologists and their patients encounter during evaluation and management of systemic therapy. Both projects utilize patient and clinician surveys with linkages to cancer registry data and industry-provided data on risk of recurrence scores (OncotypeDX) and genetic test results.
A third program project is an intervention study that tests the usefulness of an online decision tool (iCanDecide) to help women make locoregional and systemic treatment decisions. The scope of research in the P01 has also been expanded to address the perspectives and roles of informal decision support networks (family and friends) for patients deliberating about breast cancer treatment options.
Individualization of Locoregional Management for Early-Stage Breast Cancer (Reshma Jagsi, MD, DPhil-Project Lead)
As part of the larger, P01 Project 1 focuses on challenges that surgeons and their patients face during evaluation and management of locoregional therapies. The project is a population-based study of patients newly diagnosed with breast cancer and reported to the Surveillance, Epidemiology and End Results (SEER) registries of Los Angeles and Georgia, as well as their surgeons. Aim 1 is to examine the use of newer evaluative tests (breast MRI and genetic testing for BRCA1/2 mutation) for patients diagnosed with breast cancer and the patient and clinician correlates of testing. Aim 2 is to examine the receipt of contralateral prophylactic mastectomy, omission of ALND, and PBI, and the patient and clinician correlates of uptake of these emerging approaches for locoregional management of breast cancer. As part of this aim, we will evaluate the effects of newer evaluative tests on receipt of treatments. Aim 3 is to explore the individualization of decision-making by evaluating the extent to which patients are informed about tests and treatments and are satisfied with the decision-making process.
Individualization of Systemic Therapy in Patients with Estrogen Receptor-Positive Breast Cancer (Allison Kurian, MD, MSc- Project Lead)
Project 2 focuses on the challenges that medical oncologists and their patients encounter during evaluation and management of systemic therapy. Aim 1 is to examine patient and clinician factors associated with the use of the 21-gene assay and the extent to which use of the assay is individualized. Aim 2 is to examine patient and clinician factors associated with use of chemotherapy among patients with ER-positive disease and the extent to which use of the assay leads to individualized chemotherapy receipt. For each of the hypotheses in Aims 1 and 2, we will explore the role of clinician attitudes about the 21-gene assay and about the consequences of omitting chemotherapy and the role of patients’ concerns about recurrence, concerns about harmful effects of treatment, patient ratings of patient-clinician communication, and input from partners, family and friends in chemotherapy use. Aim 3 is to examine the impact of the assay on patient knowledge about risk of cancer recurrence and benefits of chemotherapy and satisfaction with decision-making processes related to receipt of chemotherapy.
Individualizing Decision Quality for Patients with Breast Cancer: A RCT of a Comprehensive Breast Cancer Treatment Patient Decision Tool (Sarah Hawley, PhD, MPH- Project Lead)
Project 3 is an RCT of an online deliberation portal (iCanDecide) for patients newly diagnosed with breast cancer. The P3 tool was developed with the Center for Health Communication Research and recently deployed in local Detroit area and Atlanta-based surgical oncology practices. The goal of this trial is to evaluate the impact of the decision tool on locoregional and systemic therapy decisions. The tool was developed to support high quality medical decision-making, defined as a decision that is informed and demonstrates concordance between the treatment received and patient values and preferences. This project also utilizes baseline and follow-up surveys (4 weeks and 9 months after using the decision tool) to collect information about women’s decision making methods.