Cardiovascular Risk and Preventive Care in Prostate Cancer Patients Receiving Radiation and Hormone Therapy
13 augusti 2018 uppdaterad av: UNC Lineberger Comprehensive Cancer Center
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.
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.
Studieöversikt
Status
Avslutad
Betingelser
Studietyp
Observationell
Inskrivning (Faktisk)
101
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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District of Columbia
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Washington, District of Columbia, Förenta staterna, 20007
- MedStar Georgetown University Hospital
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North Carolina
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Chapel Hill, North Carolina, Förenta staterna, 27599
- University of North Carolina at Chapel Hill Cancer Hospital
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High Point, North Carolina, Förenta staterna, 27262
- High Point Regional UNC Health Care
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Raleigh, North Carolina, Förenta staterna, 27607
- Rex Healthcare, Inc
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Raleigh, North Carolina, Förenta staterna, 27614
- Rex Healthcare of Wakefield
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Washington, North Carolina, Förenta staterna, 27889
- Marion L. Shepard Cancer Center
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Wilmington, North Carolina, Förenta staterna, 28401
- Coastal Carolina Radiation Oncology
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Virginia
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Charlottesville, Virginia, Förenta staterna, 22908
- University of Virginia
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Manlig
Testmetod
Icke-sannolikhetsprov
Studera befolkning
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.
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: Kohort
- Tidsperspektiv: Blivande
Kohorter och interventioner
Grupp / Kohort |
|---|
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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.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Proportion of prostate cancer patients with controlled blood sugars, blood pressure, and cholesterol profile.
Tidsram: Baseline
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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.
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Baseline
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Proportion of prostate cancer patients with controlled blood sugars, blood pressure, and cholesterol profile.
Tidsram: 3 months post radiation treatment completion
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Blood sugars include fasting glucose and hemoglobin A1c; blood pressure includes systolic and diastolic; and cholesterol profile includes total cholesterol, LDL, HDL, and triglycerides.
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3 months post radiation treatment completion
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Proportion of prostate cancer patients with controlled blood sugars, blood pressure, and cholesterol profile.
Tidsram: 12 months post radiation treatment completion
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Blood sugars include fasting glucose and hemoglobin A1c; blood pressure includes systolic and diastolic; and cholesterol profile includes total cholesterol, LDL, HDL, and triglycerides.
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12 months post radiation treatment completion
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Proportion of prostate cancer patients with guideline-recommended cardiovascular preventive care (glucose testing, cholesterol testing, and blood pressure measurement).
Tidsram: Baseline
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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).
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Baseline
|
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Proportion of prostate cancer patients with guideline-recommended cardiovascular preventive care (glucose testing, cholesterol testing, and blood pressure measurement).
Tidsram: 12 months post radiation treatment completion
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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).
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12 months post radiation treatment completion
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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).
Tidsram: 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).
|
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).
Tidsram: 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).
|
12 months post radiation treatment completion
|
|
Patient-reported quality of life.
Tidsram: Baseline
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Baseline
|
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Patient-reported quality of life.
Tidsram: 12 months post radiation treatment completion
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12 months post radiation treatment completion
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Patient-reported coordination of care.
Tidsram: Baseline
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Baseline
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Patient-reported coordination of care.
Tidsram: 12 months post radiation treatment completion
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12 months post radiation treatment completion
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Patient-reported satisfaction with care.
Tidsram: Baseline
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Baseline
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Patient-reported satisfaction with care.
Tidsram: 12 months post radiation treatment completion
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12 months post radiation treatment completion
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Samarbetspartners
Utredare
- Huvudutredare: Ronald C Chen, MD, MPH, University of North Carolina at Chapel Hill - Department of Radiation Oncology
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Användbara länkar
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 juni 2012
Primärt slutförande (Faktisk)
1 juli 2016
Avslutad studie (Faktisk)
4 maj 2018
Studieregistreringsdatum
Först inskickad
18 november 2013
Först inskickad som uppfyllde QC-kriterierna
2 december 2013
Första postat (Uppskatta)
6 december 2013
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
14 augusti 2018
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
13 augusti 2018
Senast verifierad
1 augusti 2018
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- LCCC 1218
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .