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

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Prostate Cancer

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Non-metastatic prostate cancer patients<br>Histologically-confirmed, non-metastatic prostate cancer patients who received external beam radiation treatment with androgen deprivation therapy (total ADT duration > 3 months) for definitive treatment. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| Patient-reported quality of life. |  | Baseline | 
| Patient-reported quality of life. |  | 12 months post radiation treatment completion | 
| Patient-reported coordination of care. |  | Baseline | 
| Patient-reported coordination of care. |  | 12 months post radiation treatment completion | 
| Patient-reported satisfaction with care. |  | Baseline | 
| Patient-reported satisfaction with care. |  | 12 months post radiation treatment completion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostate cancer, External beam radiation treatment, Androgen deprivation therapy, Definitive treatment, Cardiovascular risk factors, Quality of life