Hem Onc Research Patient Decision Making, Health Services Research and Education

Several faculty members in the Division of Hematology and Oncology conduct health services and educational research to address broad questions related to medical education, healthcare delivery, physician-patient communication and decision making, and outcomes.

Dr. Lisa Arfons, in collaboration with Melanie Lynch MD, Section Chief of General Surgery; Jennifer Smith CNP, Department of General Surgery, holds a Center of Excellence in Specialty Care Education grant by the VA Office of Academic Affiliations. This award is a three year, $1.5 million grant to support the transformation of clinical education and patient care by preparing graduates of health professional schools and programs to work in and lead patient-centered interdisciplinary and/or interprofessional teams providing oncology care. The new Center of Excellence in Cancer Specialty Care, formally known as “Transforming and Integrating Medical and Surgical Expertise (COE-TIE)” has the goal to provide timely, patient-centered interdisciplinary and interprofessional specialty care to patients referred by their primary care provider with a positive screening test, concerning symptoms or diagnosis of cancer. Our Cancer Specialty Care COE provides a novel integrated clinical environment that facilitates multiple coordinated specialty consultations including surgical oncology, medical oncology, survivorship, behavioral health, nutrition and social work. The COE-TIE also provides a forum for the training of residents in Family Medicine, Dermatology, Internal Medicine and Surgery; fellows in Medical Oncology; and nurse practitioner and psychology students in interdisciplinary and interprofessional teams, emphasizing patient-centered approaches to specialty consultation and coordination of care. The core competencies of patient-centered clinical practice guide our educational plan.

With funding from the Gold Humanism Honor Society (GHHS), Arfons and other educational leaders are piloting a residency and fellowship chapter of the GHHS at UH-CMC and the Louis Stokes Cleveland VA Medical Center. They are collaborating with the national GHHS Resident Task Force to develop national standards for nomination, selection and induction of trainees into the GHHS resident chapters, followed by induction of members here at our local institutions. The grant also supports ongoing humanism in medicine initiatives such as resident/fellow book clubs, a hospital-wide wellness curriculum and local programs with various art/music programs and museums.

Dr. Rami Manochakian joined the faculty in September 2012. He leads a quality improvement program focused on the timeliness of diagnosis and treatment of lung cancers. In collaboration with Jennifer Smith (NP), Manochakian recently received a $500,000 award from the Specialty Care Transformation Office in the Department of Veteran Affairs. The project is entitled “IVALu Cancer Care: Improving Veteran Access to Lung Cancer Care." The overall goal of this project is to build a designated multidisciplinary lung cancer program that delivers a multi-specialty coordinated care for veterans with lung cancer. The project will optimize timeliness of diagnosis and treatment, implement a patient navigation system as well as lung cancer care tracking system, and improve lung cancer patients’ access to palliative care and survivorship care.

Drs. Nathan Berger and Cynthia Owusu are pursuing two major research themes in Geriatric-Oncology:

  1. Cancer Survivorship Health Issues (Health Services Research)
  2. Treatment Tolerance and Efficacy  (Clinical Trials)

 

Cancer Survivorship Health Issues: Dr. Owusu’s research efforts over the past year have focused on older women with breast cancer with a goal to 1) improve early identification of functional decline; and 2) develop interventions to ameliorate functional decline in this setting.

“Improving Cancer Outcomes for Older Women with Breast Cancer” is supported by a Susan Komen Breast Cancer Foundation Career Development Award (Owusu C, PI). The study aims to identify clinical and biological determinants of functional decline in older women with early stage breast cancer. As of June 2013, 165 out of a target of 200 women have been enrolled. Baseline cross-sectional analyses have been conducted, presented at ASCO and one publication is in press. “Racial Disparities in Functional Disability among Older Women with Newly Diagnosed Non-metastatic Breast Cancer”, Owusu C, Schluchter M, Koroukian SM, Mazhuvanchery, S, Berger N, in press, The Cancer Journal, is a study which examined racial disparities in self-reported functional outcomes using data from the cohort described above. Results showed racial disparity in functional outcomes with African-American women more likely to have functional disability at baseline in comparison with Non-Hispanic Caucasians. Socio-economic status (median household income and educational status), chronic medical problems and obesity partly explained the racial gap in functional status.

A second study examined racial differences in physical performance (an objective assessment rather than self-report) among older women with stage I-III breast cancer and identified a higher prevalence of sub-clinical inflammation (interleukin 6 and C-reactive Protein) and a lack of physical activity as factors contributing to the racial gap in functional outcomes. These preliminary results have been presented at the 2013 ASCO annual meeting,  [Owusu C, Schluchter M, Koroukain S, Schmidt  K, Berger N. Black-white disparity in physical performance among older women with breast cancer: The role of physical activity and inflammation. J Clin Oncol 31, 2013 (suppl; abstr 6525)]

 

Treatment Tolerance and Efficacy: In collaboration with the multicenter Cancer and Aging Research Group (CARG), Dr. Owusu conducted a 500-patient study to evaluate the ability of a Comprehensive Geriatric Assessment (CGA) to predict chemotherapy toxicity in older adults in Cancer. The results of this study showed that the CGA predicts chemotherapy toxicity. Results were published in the Journal of Clinical Oncology, (J Clin Oncol 29:3457-65, 2011). A follow-up study entitled “Biological and Clinical Determinants of Chemotherapy Toxicity” is a collaborative effort by CARG. The study is funded by the National Institutes on Aging, 1R01AG037037-01A1, Hurria, A: PI) The study aims to validate the predictive model of chemotherapy toxicity developed in the study above, in older adults with breast cancer.

In 2012 and 2013 research efforts included continued accrual into Safety and Efficacy of Single Agent Adjuvant Trastuzumab in Older women with Early-stage Her2 Positive Breast Cancer”, (Cynthia Owusu: PI). This is a phase II open label single arm clinical trial of older women with early stage her2 positive breast cancer  aimed at evaluating the  three-year cumulative incidence of cardiac events associated with single agent trastuzumab use in the adjuvant setting as well as treatment efficacy.  Secondary objectives include three-year disease-free and overall survival, longitudinal geriatric assessments, physiologic cardiac markers for cardiac monitoring and long-term cardiac monitoring to evaluate for the long-term sequelae of trastuzumab-induced cardiotoxicty. Other collaborating institutions include Wake Forest University, University of Pittsburgh, Duke University and University of Miami.

Dr. Neal Meropol is conducting studies of patient decision-making, and methods to overcome barriers to clinical trial participation. The PRE-ACT study (Preparatory Education About Clinical Trials, R01 CA127655) is a web-based tailored intervention to deliver video messages to patients to address their personal barriers to considering a clinical trial as a treatment option. The underlying hypothesis is that psychosocial barriers to clinical trial participation may be overcome by systematically assessing and addressing these barriers before the oncologist visit. A randomized clinical trial of more than 1000 patients was recently completed, comparing PRE-ACT against usual care (generic clinical trials text) in improving preparation for clinical trial decision making. Initial results were presented at the annual meeting of the American Society of Clinical Oncology (ASCO) in 2013. PRE-ACT was associated with improved clinical trials knowledge, reduced clinical trials attitudinal barriers, and improved preparation for decision making about clinical trials. Notably, clinical trials text also benefitted patients in these endpoints. PRE-ACT was superior to text in improving knowledge and reducing attitudinal barriers, and was also preferred by patients overall. Plans for dissemination of PRE-ACT are underway. In a recent initiative, Drs. Meropol and Campagnaro are exploring the attitudes of oncology nurses about clinical trials and the impact of these beliefs on patient decision making regarding clinical trials.

In 2012, Meropol published the final results of a descriptive study of the perceptions of patients who enroll in phase I clinical trials (J Clin Oncol 30:4396-4400, 2012.). This study (R01 CA100771, K. Weinfurt, PI) documented that the expectations of patients regarding the benefits of phase I trials are dependent on how the question of benefit is asked. Specifically, the expectation of benefit is higher when the query is framed as a belief-type estimate rather than a frequency-type estimate. Thus, assessment of the adequacy of informed consent must take into account linguistic considerations, as patients may not be answering the question that researchers think they are asking.

Meropol also reported the final results of the CONNECT study (NCI CA82085), a web-based intervention to provide communication skills training to cancer patients (Cancer 119:1437-45, 2013). Patients receiving the CONNECT program felt that their treatment decisions were easier to reach (P = .003) and were more satisfied with these decisions (P < .001). In addition, patients reported higher levels of satisfaction with physician communication format (P = .026) and discussion regarding support services (P = .029) and quality of life concerns (P = .042) compared wit ha control intervention.

With support from the NIH-sponsored Cleveland Clinical Translational Science Collaboarative, Dr. Meropol and colleagues developed a prototype of Trial Prospector, an automated clinical trials matching program. The goal of this program is to overcome the practical barrier of time and effort required for physicians to identify clinical trials for their patients in a busy clinical practice. Trial Prospector is a point-of-care computer application that extracts patient clinical data from hospital information systems and matches these characteristics to available clinical trials eligibility criteria. A pilot test of Trial Prospector among patients with gastrointestinal cancers demonstrated the feasibility and accuracy of this approach. Preliminary results were presented at the 2013 ASCO annual meeting.

The rising costs of healthcare in conjunction with increased cost-sharing by patients raises the potential to negatively impact cancer care. As an initial effort to explore whether demand for cancer treatment is inelastic from a patient economic perspective, Meropol and YN Wong (K07 CA136995) conducted a survey of cancer patients to assess willingness to pay for treatments with specified benefits. The results demonstrated that cancer patients are sensitive to treatment value, with implications for insurance design (Medical Care, in press).