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

NCT02003417 | Completed

• 1 other identifier: LCCC 1218
• Study Type: observational
• Target: 101
• Locations: 1 country
• Sites: 8

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.

Conditions

Prostate Cancer

Keywords

Prostate cancer; External beam radiation treatment; Androgen deprivation therapy; Definitive treatment; Cardiovascular risk factors; Quality of life

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Proportion of prostate cancer patients with controlled blood sugars, blood pressure, and cholesterol profile.

  3 months post radiation treatment completion

• Proportion of prostate cancer patients with controlled blood sugars, blood pressure, and cholesterol profile.

  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).

  Baseline

• Proportion of prostate cancer patients with guideline-recommended cardiovascular preventive care (glucose testing, cholesterol testing, and blood pressure measurement).

  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).

  Baseline

Study Arms (1)

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 Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead
• Radiation Therapy Oncology Group: collaborator

Study Sites (8)

Medstar Georgetown University Hospital

Washington D.C., District of Columbia, 20007, United States

Location

University of North Carolina at Chapel Hill Cancer Hospital

Chapel Hill, North Carolina, 27599, United States

Location

High Point Regional UNC Health Care

High Point, North Carolina, 27262, United States

Location

Rex Healthcare, Inc

Raleigh, North Carolina, 27607, United States

Location

Rex Healthcare of Wakefield

Raleigh, North Carolina, 27614, United States

Location

Marion L. Shepard Cancer Center

Washington, North Carolina, 27889, United States

Location

Coastal Carolina Radiation Oncology

Wilmington, North Carolina, 28401, United States

Location

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Related Links

• UNC Lineberger Comprehensive Cancer Center
• National Cancer Institute

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Ronald C Chen, MD, MPH

  University of North Carolina at Chapel Hill - Department of Radiation Oncology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2013
• First Posted: December 6, 2013
• Study Start: June 1, 2012
• Primary Completion: July 1, 2016
• Study Completion: May 4, 2018
• Last Updated: August 14, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)