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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02003417
Recruitment Status : Completed
First Posted : December 6, 2013
Last Update Posted : August 14, 2018
Sponsor:
Collaborator:
Radiation Therapy Oncology Group
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center

Study Description
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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.

Condition or disease
Prostate Cancer

Study Design
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Study Type : Observational
Actual Enrollment : 101 participants
Observational Model: Cohort
Time Perspective: Prospective
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 Start Date : June 2012
Actual Primary Completion Date : July 2016
Actual Study Completion Date : May 4, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Groups and Cohorts
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Group/Cohort
Non-metastatic prostate cancer patients
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.


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of prostate cancer patients with controlled blood sugars, blood pressure, and cholesterol profile. [ Time Frame: 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 :
  1. Proportion of prostate cancer patients with controlled blood sugars, blood pressure, and cholesterol profile. [ Time Frame: 3 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.

  2. Proportion of prostate cancer patients with controlled blood sugars, blood pressure, and cholesterol profile. [ Time Frame: 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.

  3. Proportion of prostate cancer patients with guideline-recommended cardiovascular preventive care (glucose testing, cholesterol testing, and blood pressure measurement). [ Time Frame: Baseline ]
    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).

  4. 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 ]
    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).

  5. 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 ]
    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).

  6. 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 ]
    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).

  7. Patient-reported quality of life. [ Time Frame: Baseline ]
  8. Patient-reported quality of life. [ Time Frame: 12 months post radiation treatment completion ]
  9. Patient-reported coordination of care. [ Time Frame: Baseline ]
  10. Patient-reported coordination of care. [ Time Frame: 12 months post radiation treatment completion ]
  11. Patient-reported satisfaction with care. [ Time Frame: Baseline ]
  12. Patient-reported satisfaction with care. [ Time Frame: 12 months post radiation treatment completion ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02003417


Locations
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United States, District of Columbia
Medstar Georgetown University Hospital
Washington, District of Columbia, United States, 20007
United States, North Carolina
University of North Carolina at Chapel Hill Cancer Hospital
Chapel Hill, North Carolina, United States, 27599
High Point Regional UNC Health Care
High Point, North Carolina, United States, 27262
Rex Healthcare, Inc
Raleigh, North Carolina, United States, 27607
Rex Healthcare of Wakefield
Raleigh, North Carolina, United States, 27614
Marion L. Shepard Cancer Center
Washington, North Carolina, United States, 27889
Coastal Carolina Radiation Oncology
Wilmington, North Carolina, United States, 28401
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
UNC Lineberger Comprehensive Cancer Center
Radiation Therapy Oncology Group
Investigators
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Principal Investigator: Ronald C Chen, MD, MPH University of North Carolina at Chapel Hill - Department of Radiation Oncology
More Information
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Additional Information:

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Responsible Party: UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT02003417    
Other Study ID Numbers: LCCC 1218
First Posted: December 6, 2013    Key Record Dates
Last Update Posted: August 14, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by UNC Lineberger Comprehensive Cancer Center:
Prostate cancer
External beam radiation treatment
Androgen deprivation therapy
 Definitive treatment
Cardiovascular risk factors
Quality of life
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
 Neoplasms by Site
Neoplasms
Prostatic Diseases