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

Completed

• Conditions: Prostate Cancer

• Registration Number: NCT02003417
• Lead Sponsor: UNC Lineberger Comprehensive Cancer Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2013-11-18
• Study First Submitted QC: 2013-12-02
• Study First Posted: 2013-12-06
• Primary Completion: 2016-07
• Study Completion: 2018-05-04
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-13
• Last Update Posted: 2018-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 101

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of prostate cancer patients with controlled blood sugars, blood pressure, and cholesterol profile.	Baseline	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.

Secondary Outcome Measures

Name	Time	Method
Patient-reported coordination of care.	12 months post radiation treatment completion
Proportion of prostate cancer patients with controlled blood sugars, blood pressure, and cholesterol profile.	12 months post radiation treatment completion	Blood sugars include fasting glucose and hemoglobin A1c; blood pressure includes systolic and diastolic; and cholesterol profile includes total cholesterol, LDL, HDL, and triglycerides.
Proportion of prostate cancer patients with guideline-recommended cardiovascular preventive care (glucose testing, cholesterol testing, and blood pressure measurement).	12 months post radiation treatment completion	This will be done by patient self-report and by medical record review (radiation oncologist will obtain medical records from patient's primary care physician).
Proportion of prostate cancer patients who receive other (non-cardiovascular) guideline-recommended primary and preventive care (flu vaccination, colorectal cancer screening, and healthy lifestyle counseling).	12 months post radiation treatment completion	This will be done by patient self-report and by medical record review (radiation oncologist will obtain medical records from patient's primary care physician).
Patient-reported quality of life.	12 months post radiation treatment completion
Patient-reported satisfaction with care.	12 months post radiation treatment completion

Trial Locations

Locations (8)

University of Virginia; 🇺🇸 Charlottesville, Virginia, United States

Medstar Georgetown University Hospital; 🇺🇸 Washington, District of Columbia, United States

Rex Healthcare of Wakefield; 🇺🇸 Raleigh, North Carolina, United States

High Point Regional UNC Health Care; 🇺🇸 High Point, North Carolina, United States

Marion L. Shepard Cancer Center; 🇺🇸 Washington, North Carolina, United States

Rex Healthcare, Inc; 🇺🇸 Raleigh, North Carolina, United States

University of North Carolina at Chapel Hill Cancer Hospital; 🇺🇸 Chapel Hill, North Carolina, United States

Coastal Carolina Radiation Oncology; 🇺🇸 Wilmington, North Carolina, United States