Overview

This trial is active, not recruiting.

Condition prostate cancer
Sponsor UNC Lineberger Comprehensive Cancer Center
Collaborator Radiation Therapy Oncology Group
Start date June 2012
End date July 2016
Trial size 101 participants
Trial identifier NCT02003417, LCCC 1218

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
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.

Primary Outcomes

Measure
Proportion of prostate cancer patients with controlled blood sugars, blood pressure, and cholesterol profile.
time frame: Baseline

Secondary Outcomes

Measure
Proportion of prostate cancer patients with controlled blood sugars, blood pressure, and cholesterol profile.
time frame: 3 months post radiation treatment completion
Proportion of prostate cancer patients with controlled blood sugars, blood pressure, and cholesterol profile.
time frame: 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).
time frame: Baseline
Proportion of prostate cancer patients with guideline-recommended cardiovascular preventive care (glucose testing, cholesterol testing, and blood pressure measurement).
time frame: 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).
time frame: 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).
time frame: 12 months post radiation treatment completion
Patient-reported quality of life.
time frame: Baseline
Patient-reported quality of life.
time frame: 12 months post radiation treatment completion
Patient-reported coordination of care.
time frame: Baseline
Patient-reported coordination of care.
time frame: 12 months post radiation treatment completion
Patient-reported satisfaction with care.
time frame: Baseline
Patient-reported satisfaction with care.
time frame: 12 months post radiation treatment completion

Eligibility Criteria

Male participants at least 18 years old.

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

Additional Information

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.
Principal investigator Ronald C Chen, MD, MPH
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by UNC Lineberger Comprehensive Cancer Center.