Clinical trial NCT02003417: Cardiovascular Risk and Preventive Care in Prostate Cancer Patients Receiving Radiation and Hormone Therapy
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Keywords: Prostate cancer
External beam radiation treatment
Androgen deprivation therapy
Definitive treatment
Cardiovascular risk factors
Quality of life
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: Radiation Therapy Oncology Group
First posted: 2013-12-06
Enrollment: 101
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Histologically-confirmed, non-metastatic prostate cancer patients who visit radiation oncology clinics at participating institutions: The University of North Carolina at Chapel Hill Cancer Hospital, Rex Cancer Center at the Raleigh and Wakefield locations, Marion J. Shepard Cancer Center, Coastal Carolina Radiation Oncology, The University of Virginia, High Point Regional UNC Health Care, and MedStar Georgetown University. Patients with planned radiation treatment and androgen deprivation therapy with curative intent (in definitive or post-prostatectomy settings) are eligible.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Proportion of prostate cancer patients with controlled blood sugars, blood pressure, and cholesterol profile.
timeFrame: Baseline
Secondary outcomes:
measure: Proportion of prostate cancer patients with controlled blood sugars, blood pressure, and cholesterol profile.
timeFrame: 3 months post radiation treatment completion
measure: Proportion of prostate cancer patients with controlled blood sugars, blood pressure, and cholesterol profile.
timeFrame: 12 months post radiation treatment completion
measure: Proportion of prostate cancer patients with guideline-recommended cardiovascular preventive care (glucose testing, cholesterol testing, and blood pressure measurement).
timeFrame: Baseline
measure: Proportion of prostate cancer patients with guideline-recommended cardiovascular preventive care (glucose testing, cholesterol testing, and blood pressure measurement).
timeFrame: 12 months post radiation treatment completion
measure: 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).
timeFrame: Baseline
measure: 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).
timeFrame: 12 months post radiation treatment completion
measure: Patient-reported quality of life.
timeFrame: Baseline
measure: Patient-reported quality of life.
timeFrame: 12 months post radiation treatment completion
measure: Patient-reported coordination of care.
timeFrame: Baseline
measure: Patient-reported coordination of care.
timeFrame: 12 months post radiation treatment completion
measure: Patient-reported satisfaction with care.
timeFrame: Baseline
measure: Patient-reported satisfaction with care.
timeFrame: 12 months post radiation treatment completion
Other outcomes:
Locations:
city: Washington
country: United States
facility: Medstar Georgetown University Hospital
state: District of Columbia
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill Cancer Hospital
state: North Carolina
city: High Point
country: United States
facility: High Point Regional UNC Health Care
state: North Carolina
city: Raleigh
country: United States
facility: Rex Healthcare, Inc
state: North Carolina
city: Raleigh
country: United States
facility: Rex Healthcare of Wakefield
state: North Carolina
city: Washington
country: United States
facility: Marion L. Shepard Cancer Center
state: North Carolina
city: Wilmington
country: United States
facility: Coastal Carolina Radiation Oncology
state: North Carolina
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
affiliation: University of North Carolina at Chapel Hill - Department of Radiation Oncology
name: Ronald C Chen, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: