- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01441713
Treatment Frequency and Satisfaction in Patients With Advanced Prostate Cancer
Patients with advanced prostate cancer usually receive some kind of pharmaceutical castration or undergo surgical castration. At the investigators department the pharmaceutical treatment is most often given with a 3 month interval.
Over the last few years new drugs, which allow for lees frequent treatment, have been developed. The purpose of this study is to assess how the treatment affects patients and if our current patients would prefer to receive treatment at different intervals than they do at the present time. At the same time the investigators will assess how surgical treatment affects our patients. This will be assessed by patient questionnaires administered at our clinic.
Studieoversikt
Status
Forhold
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
-
-
-
Herlev, Danmark, 2730
- Department of Urology, Herlev Hospital
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- A diagnosis of advanced prostate cancer
- Receiving hormone manipulation treatment (pharmaceutical castration) OR having undergone surgical castration (orchiectomy)
Exclusion Criteria:
- Inability to read/write Danish
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
|---|
|
Pharmaceutical group
Patients in pharmaceutical castration treatment for advanced prostate cancer
|
|
Surgical group
Patients having undergone surgical castration treatment for advanced prostate cancer
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Preferred treatment/control frequency for patients with advanced prostate cancer
Tidsramme: Up to 1 year
|
Preferred treatment frequency is assessed by patient answers to the question: "If treatments were equally effective from a medical standpoint - How often would you then prefer to receive treatment" |
Up to 1 year
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Treatment satisfaction
Tidsramme: Up to 1 year
|
Treatment satisfaction ranging from "Very satisfied" til "Very unsatisfied" assessed by patient answers to the questionnaire
|
Up to 1 year
|
|
Side effects to treatment
Tidsramme: Up to 1 year
|
Side effects to treatment assessed by patient answers to the questionnaire
|
Up to 1 year
|
|
Treatment satisfaction, preferred frequency of clinical control, and side effects after surgical castration
Tidsramme: Up to 1 year
|
As a secondary endpoint the investigators will look at answers to satisfaction, wishes for control visits and side effects in the group of patients who received surgical castration for their advanced prostate cancer.
|
Up to 1 year
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Mikkel Fode, MD, Herlev Hospital, University of Copenhagen
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- HeH.750.19-25
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