Summer Student Research Program Project Description FACULTY SPONSOR’S NAME AND DEGREE: Denise Fyffe, Ph.D., Charlie Cathcart, M.D. PHONE: (973) 972 - 8968 DEPARTMENT AND INTERNAL MAILING ADDRESS: Institute for the Elimination of Health Disparities, SSB-742 E-MAIL: [email protected] PROJECT TITLE (200 Characters max):

Risk Factors and Outcomes Associated with Adherence Trends in Radiation Treatment among Urban Cancer Patients

HYPOTHESIS: Hypothesis 1: Patients with low adherence ratios will have poorer clinical outcomes in comparison to patients with high adherence ratios.

Hypothesis 2: Minority status, prognostic and socioeconomic position (SEP) disadvantage will be associated with poorer adherence ratios and clinical outcomes.

PROJECT DESCRIPTION (Include design, methodology, data collection, techniques, data analysis to be employed and evaluation and interpretation methodology)

Study Overview and Objectives: Nonadherence to cancer treatment is a pressing problem for cancer patients that is not being adequately addressed (DiMatteo et al, 1992; Hershman et al, 2003; Bickell et al, 2006). Relapse-free survival and total survival rates are poorer when cancer patients delay the initiation or discontinue radiation therapy. Little is known about the factors that influence varying adherence levels and the clinical outcomes among cancer patients to radiation therapy, particularly among minority cancer patients. This project will examine the risk factors and outcomes associated with varying adherence ratios among patients seeking radiation treatment in an urban hospital.

Study Design: This study will employ a retrospective study design.

Data Collection: Data will be collected using standardized chart review methods.

Sample: The sample will be restricted to patients treated for prostate, breast, head and neck cancers in the New Jersey Medical School – University Hospital Cancer Center Radiation Oncology Department. Patients that received postoperative or definitive radiation therapy July 2006 through December 2006 will be included in the study sample. Patients that have distant metastases will not be eligible.

Outcome Variable: The main outcome variable will be adherence ratios (AR). Adherence ratios will be determined by number of radiation treatments completed/number of prescribed radiation treatment days. Two categories of adherence will be determined: 1) nonadherent patients (AR greater than two standard deviations outside the prescribed minimum treatment); 2) adherent patients (AR less than one standard deviation of their prescribed minimum treatment).

Independent Variables: Race, prognostic factors and socioeconomic position indicators (education, employment status, insurance type) are the primary independent variables. Summer Student Research Program Project Description Analyses: Descriptive statistics will summarize the overall percentages of persons who are adherent and nonadherent. Simple percentages and standard errors will be calculated for each race-by-site combination. Further, chi-square tests and t-tests, as appropriate, will determine whether the groups of across cancer sites are comparable.

All formal analyses will be conducted using logistic regression, so that, for example, when comparing adherence ratios of participation for race/ethnicity groups, we can control for differences in age, gender and cancer site between the groups. If appropriate, separate regressions will be run for each cancer site. From logistic regression models fitted, type 3 Wald tests will examine the effect of race/ethnicity, gender and cancer site on the adherence ratios. All statistical analyses will be conducted using the SPSS programming language.

SPONSOR’S MOST RECENT PUBLICATIONS RELEVANT TO THIS RESEARCH: 1. Cathcart, C.S., Dunican, A., Halpern, J.N., Patterns of delivery of radiation therapy in an inner- city population of head and neck cancer patients: an analysis of compliance and end results Journal of Medicine 1997; 28, Nos. 5 & 6:275-284.

2. Schulder, M., Vega, J., Narra, V., Cathcart, C.S., Kalnin, A.J., Liu, W.C., Functional Magnetic Resonance Imaging and Radiosurgical Dose Planning. Stereotact Funct Neurosurg 2000.

IS THIS PROJECT SUPPORTED BY EXTRAMURAL FUNDS? Yes or No (IF YES, PLEASE SUPPLY THE GRANTING AGENCY’S NAME)

THIS PROJECT IS: Clinical Laboratory Behavioral Other

THIS PROJECT IS CANCER-RELATED Please explain Cancer relevance

The study will be examining factors that influence adherence to cancer treatment.

THIS PROJECT IS HEART, LUNG & BLOOD- RELATED Please explain Heart, Lung, Blood relevance

THIS PROJECT EMPLOYS RADIOISOTOPES

THIS PROJECT INVOLVES THE USE OF ANIMALS

PENDING APPROVED IACUC PROTOCOL #

THIS PROJECT INVOLVES THE USE OF HUMAN SUBJECTS

PENDING APPROVED IRB PROTOCOL # M

THIS PROJECT IS SUITABLE FOR: UNDERGRADUATE STUDENTS ENTERING FRESHMAN SOPHMORES ALL STUDENTS

THIS PROJECT IS WORK-STUDY: Yes or No Summer Student Research Program Project Description

WHAT WILL THE STUDENT LEARN FROM THIS EXPERIENCE? This project can accept 2 students, preferably 1 medical student and 1 work-study student. The students will conduct the chart review, data entry and review data for accuracy. They will learn about research protocols, protection of human subjects, privacy and confidentiality, development of chart abstraction form, and methods of chart abstraction. They will learn ways to conduct quality reviews in conducting chart review and data entry. They will learn about developing and management of patient databases. The students will attend research meetings to inform research staff of changes and problems encountered in the project. The students will also attend clinical radiation oncology meetings to learn medical terminology and gain exposure to clinical conference and cancer patients undergoing radiation treatment.