Cardiovascular Risk and Preventive Care in Prostate Cancer Patients Receiving Radiation and Hormone Therapy
13. august 2018 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
101
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
District of Columbia
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Washington, District of Columbia, Forenede Stater, 20007
- MedStar Georgetown University Hospital
-
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North Carolina
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Chapel Hill, North Carolina, Forenede Stater, 27599
- University of North Carolina at Chapel Hill Cancer Hospital
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High Point, North Carolina, Forenede Stater, 27262
- High Point Regional UNC Health Care
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Raleigh, North Carolina, Forenede Stater, 27607
- Rex Healthcare, Inc
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Raleigh, North Carolina, Forenede Stater, 27614
- Rex Healthcare of Wakefield
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Washington, North Carolina, Forenede Stater, 27889
- Marion L. Shepard Cancer Center
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Wilmington, North Carolina, Forenede Stater, 28401
- Coastal Carolina Radiation Oncology
-
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Virginia
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Charlottesville, Virginia, Forenede Stater, 22908
- University of Virginia
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Han
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
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.
Beskrivelse
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Kohorte
- Tidsperspektiver: Fremadrettet
Kohorter og interventioner
Gruppe / kohorte |
|---|
|
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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Proportion of prostate cancer patients with controlled blood sugars, blood pressure, and cholesterol profile.
Tidsramme: 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.
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Baseline
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Proportion of prostate cancer patients with controlled blood sugars, blood pressure, and cholesterol profile.
Tidsramme: 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.
|
3 months post radiation treatment completion
|
|
Proportion of prostate cancer patients with controlled blood sugars, blood pressure, and cholesterol profile.
Tidsramme: 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.
|
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).
Tidsramme: 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 with guideline-recommended cardiovascular preventive care (glucose testing, cholesterol testing, and blood pressure measurement).
Tidsramme: 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
|
|
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).
Tidsramme: 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).
Tidsramme: 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.
Tidsramme: Baseline
|
Baseline
|
|
|
Patient-reported quality of life.
Tidsramme: 12 months post radiation treatment completion
|
12 months post radiation treatment completion
|
|
|
Patient-reported coordination of care.
Tidsramme: Baseline
|
Baseline
|
|
|
Patient-reported coordination of care.
Tidsramme: 12 months post radiation treatment completion
|
12 months post radiation treatment completion
|
|
|
Patient-reported satisfaction with care.
Tidsramme: Baseline
|
Baseline
|
|
|
Patient-reported satisfaction with care.
Tidsramme: 12 months post radiation treatment completion
|
12 months post radiation treatment completion
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Ronald C Chen, MD, MPH, University of North Carolina at Chapel Hill - Department of Radiation Oncology
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Hjælpsomme links
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. juni 2012
Primær færdiggørelse (Faktiske)
1. juli 2016
Studieafslutning (Faktiske)
4. maj 2018
Datoer for studieregistrering
Først indsendt
18. november 2013
Først indsendt, der opfyldte QC-kriterier
2. december 2013
Først opslået (Skøn)
6. december 2013
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
14. august 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
13. august 2018
Sidst verificeret
1. august 2018
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- LCCC 1218
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Ingen
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