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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by UNC Lineberger Comprehensive Cancer Center
Sponsor:
Collaborator:
Radiation Therapy Oncology Group
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT02003417
First received: November 18, 2013
Last updated: December 6, 2013
Last verified: December 2013
  Purpose

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
Prostate Cancer

Study Type: Observational
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by UNC Lineberger Comprehensive Cancer Center:

Primary Outcome Measures:
  • Proportion of prostate cancer patients with controlled blood sugars, blood pressure, and cholesterol profile. [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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:
  • Proportion of prostate cancer patients with controlled blood sugars, blood pressure, and cholesterol profile. [ Time Frame: 3 months post radiation treatment completion ] [ Designated as safety issue: No ]
    Blood sugars include fasting glucose and hemoglobin A1c; blood pressure includes systolic and diastolic; and cholesterol profile includes total cholesterol, LDL, HDL, and triglycerides.

  • Proportion of prostate cancer patients with controlled blood sugars, blood pressure, and cholesterol profile. [ Time Frame: 12 months post radiation treatment completion ] [ Designated as safety issue: No ]
    Blood sugars include fasting glucose and hemoglobin A1c; blood pressure includes systolic and diastolic; and cholesterol profile includes total cholesterol, LDL, HDL, and triglycerides.

  • Proportion of prostate cancer patients with guideline-recommended cardiovascular preventive care (glucose testing, cholesterol testing, and blood pressure measurement). [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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).

  • 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 ] [ Designated as safety issue: No ]
    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).

  • 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 ] [ Designated as safety issue: No ]
    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).

  • 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 ] [ Designated as safety issue: No ]
    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).

  • Patient-reported quality of life. [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Patient-reported quality of life. [ Time Frame: 12 months post radiation treatment completion ] [ Designated as safety issue: No ]
  • Patient-reported coordination of care. [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Patient-reported coordination of care. [ Time Frame: 12 months post radiation treatment completion ] [ Designated as safety issue: No ]
  • Patient-reported satisfaction with care. [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Patient-reported satisfaction with care. [ Time Frame: 12 months post radiation treatment completion ] [ Designated as safety issue: No ]

Estimated Enrollment: 101
Study Start Date: June 2012
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02003417

Contacts
Contact: Brittney D Barbosa, BS (919) 962-5366 brittney_barbosa@med.unc.edu

Locations
United States, District of Columbia
Medstar Georgetown University Hospital Recruiting
Washington, District of Columbia, United States, 20007
Principal Investigator: Sean Collins, MD, PhD         
United States, North Carolina
University of North Carolina at Chapel Hill Cancer Hospital Recruiting
Chapel Hill, North Carolina, United States, 27599
Principal Investigator: Ronald C Chen, MD, MPH         
Sub-Investigator: Bryce Reeve, PhD, MA         
Sub-Investigator: Raj Pruthi, MD         
Sub-Investigator: Eric Wallen, MD         
Sub-Investigator: Matthew Nielsen, MD, MS         
Sub-Investigator: Young Whang, MD, PhD         
Sub-Investigator: Paul Godley, MD, PhD         
Sub-Investigator: Kim Rathmell, MD, PhD         
Sub-Investigator: William Kim, MD         
Sub-Investigator: Andrew Wang, MD         
High Point Regional UNC Health Care Recruiting
High Point, North Carolina, United States, 27262
Principal Investigator: Kolby Sidhu, MD         
Rex Healthcare, Inc Recruiting
Raleigh, North Carolina, United States, 27607
Principal Investigator: Leroy Hoffman, MD         
Sub-Investigator: Charles Scarantino, MD, PhD         
Sub-Investigator: Justin Wu, MD         
Sub-Investigator: John Fakiris, MD         
Sub-Investigator: Courtney Bui, MD         
Sub-Investigator: Nathan Sheets, MD         
Sub-Investigator: Kim-Marie Huck, MSN, ANP-C, AOCNP         
Rex Healthcare of Wakefield Recruiting
Raleigh, North Carolina, United States, 27614
Principal Investigator: Roger Anderson, MD         
Sub-Investigator: Leroy Hoffman, MD         
Marion L. Shepard Cancer Center Recruiting
Washington, North Carolina, United States, 27889
Principal Investigator: Ronald C Chen, MD, MPH         
Sub-Investigator: Robert McLaurin, MD         
Coastal Carolina Radiation Oncology Recruiting
Wilmington, North Carolina, United States, 28401
Principal Investigator: Michael A Papagikos, MD         
Sub-Investigator: Patrick D Maguire, MD         
Sub-Investigator: Martin B Meyerson, MD         
Sub-Investigator: Charles Neal, MD         
Sub-Investigator: Michael A Nichols, MD         
United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22908
Principal Investigator: Timothy Showalter, MD         
Sponsors and Collaborators
UNC Lineberger Comprehensive Cancer Center
Radiation Therapy Oncology Group
Investigators
Principal Investigator: Ronald C Chen, MD, MPH University of North Carolina at Chapel Hill - Department of Radiation Oncology
  More Information

Additional Information:
No publications provided

Responsible Party: UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT02003417     History of Changes
Other Study ID Numbers: LCCC 1218
Study First Received: November 18, 2013
Last Updated: December 6, 2013
Health Authority: United States: Institutional Review Board

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:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Genital Diseases, Male
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 20, 2014