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

Prostate Cancer Clinical Trial

Official title:

A Multicenter Study to Evaluate Cardiovascular Risk Factors and Receipt of Primary and Preventive Care in Prostate Cancer Patients Who Receive Definitive Radiation Therapy and Androgen Deprivation Therapy.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02003417
• Other study ID #: LCCC 1218
• Status: Completed
• Start date: June 2012
• Est. completion date: May 4, 2018

Study information

• Verified date: August 2018
• Source: UNC Lineberger Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: May 4, 2018
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Locations

Country	Name	City	State
United States	University of North Carolina at Chapel Hill Cancer Hospital	Chapel Hill	North Carolina
United States	University of Virginia	Charlottesville	Virginia
United States	High Point Regional UNC Health Care	High Point	North Carolina
United States	Rex Healthcare of Wakefield	Raleigh	North Carolina
United States	Rex Healthcare, Inc	Raleigh	North Carolina
United States	Marion L. Shepard Cancer Center	Washington	North Carolina
United States	Medstar Georgetown University Hospital	Washington	District of Columbia
United States	Coastal Carolina Radiation Oncology	Wilmington	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
UNC Lineberger Comprehensive Cancer Center	Radiation Therapy Oncology Group

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline
Secondary	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.	3 months post radiation treatment completion
Secondary	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.	12 months post radiation treatment completion
Secondary	Proportion of prostate cancer patients with guideline-recommended cardiovascular preventive care (glucose testing, cholesterol testing, and blood pressure measurement).	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).	Baseline
Secondary	Proportion of prostate cancer patients with guideline-recommended cardiovascular preventive care (glucose testing, cholesterol testing, and blood pressure measurement).	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).	12 months post radiation treatment completion
Secondary	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).	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).	Baseline
Secondary	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).	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).	12 months post radiation treatment completion
Secondary	Patient-reported quality of life.		Baseline
Secondary	Patient-reported quality of life.		12 months post radiation treatment completion
Secondary	Patient-reported coordination of care.		Baseline
Secondary	Patient-reported coordination of care.		12 months post radiation treatment completion
Secondary	Patient-reported satisfaction with care.		Baseline
Secondary	Patient-reported satisfaction with care.		12 months post radiation treatment completion

External Links

•   National Cancer Institute
•   UNC Lineberger Comprehensive Cancer Center