Cardiovascular Risk and Preventive Care in Prostate Cancer Patients Receiving Radiation and Hormone Therapy

N/ACompletedNCT02003417

UNC Lineberger Comprehensive Cancer Center101 enrolled

Overview

This study will evaluate the proportion of prostate cancer patients receiving external beam radiation therapy (EBRT) and androgen deprivation therapy (ADT) with controlled blood sugars (fasting glucose and hemoglobin A1c), blood pressure, and cholesterol profile (total cholesterol, LDL, HDL, triglycerides) at baseline, 3 months, and 12 months after completing radiation treatment. In addition, receipt of guideline-recommended cardiovascular, primary and preventive care as well as patient-reported quality of life and satisfaction with care among these patients will be evaluated at baseline and 12 months.

Study Type

OBSERVATIONAL

Enrollment

101

Conditions

Prostate Cancer

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Histologically-confirmed, non-metastatic prostate cancer * Patients who will receive external beam radiation treatment with androgen deprivation therapy (total ADT duration \> 3 months) for curative treatment, either in the definitive or post-prostatectomy setting * Patients who have a primary care provider * Informed consent obtained and signed * Ability to read and write English * Age \>= 18 * No mental incompetence which would preclude completion of questionnaires Exclusion Criteria: * Prior cancer, pelvic radiation treatment or chemotherapy * Patients who do not have a primary care provider * Prior ADT * Mental incompetence which would preclude completion of questionnaires * Unable to read and write English

Locations (8)

Medstar Georgetown University Hospital

Washington D.C., District of Columbia, United States

University of North Carolina at Chapel Hill Cancer Hospital

Chapel Hill, North Carolina, United States

High Point Regional UNC Health Care

High Point, North Carolina, United States

Rex Healthcare, Inc

Raleigh, North Carolina, United States

Rex Healthcare of Wakefield

Raleigh, North Carolina, United States

Marion L. Shepard Cancer Center

Washington, North Carolina, United States

Coastal Carolina Radiation Oncology

Wilmington, North Carolina, United States

University of Virginia

Charlottesville, Virginia, United States

Outcomes

Primary Outcomes

Proportion of prostate cancer patients with controlled blood sugars, blood pressure, and cholesterol profile.

Blood sugars include fasting glucose and hemoglobin A1c; blood pressure includes systolic and diastolic; and cholesterol profile includes total cholesterol, LDL, HDL, and triglycerides. Baseline is prior to receiving androgen deprivation therapy and prior to radiation.

Time frame: Baseline

Secondary Outcomes

Proportion of prostate cancer patients with controlled blood sugars, blood pressure, and cholesterol profile.

Blood sugars include fasting glucose and hemoglobin A1c; blood pressure includes systolic and diastolic; and cholesterol profile includes total cholesterol, LDL, HDL, and triglycerides.

Time frame: 3 months post radiation treatment completion

Proportion of prostate cancer patients with controlled blood sugars, blood pressure, and cholesterol profile.

Blood sugars include fasting glucose and hemoglobin A1c; blood pressure includes systolic and diastolic; and cholesterol profile includes total cholesterol, LDL, HDL, and triglycerides.