- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02174185
Compare the Quality of Life Between Patients With Conduit Diversions or Orthotopic Neobladders
A Prospective and Comparative Study of Health-related Quality of Life (HRQoL) in Patients With Conduit Diversion or Orthotopic Neobladder
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Forventet)
Kontakter og lokationer
Studiekontakt
- Navn: Xiaoping Zhang, MD, PhD
- Telefonnummer: 86 27 85351625
- E-mail: xzhang@hust.edu.cn
Undersøgelse Kontakt Backup
- Navn: Hangchuan Shi, MD
- Telefonnummer: 86 13098893958
- E-mail: hangchuan_shi@hust.edu.cn
Studiesteder
-
-
Hubei
-
Wuhan, Hubei, Kina, 430022
- Rekruttering
- Department of Urology, Wuhan Union Hospital, Huazhong University of Science and Technology
-
Kontakt:
- Xiaoping Zhang, MD, PhD
- Telefonnummer: 86 27 85351625
- E-mail: xzhang@hust.edu.cn
-
Kontakt:
- Hangchuan Shi, MD
- Telefonnummer: 86 13098893958
- E-mail: hangchuan_shi@hust.edu.cn
-
Ledende efterforsker:
- Xiaoping Zhang, MD,PhD
-
Ledende efterforsker:
- Hangchuan Shi, MD
-
Underforsker:
- Xiang Li, MD
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- Clinical diagnosis of muscle invasive bladder cancer
- Must be scheduled for radical cystectomy and subsequent conduit diversion or orthotopic neobladder
- Must be able to provide informed consent
- Must be 18 years of age or older
- May have had received intravesical neoadjuvant, adjuvant chemotherapy or immunotherapy
Exclusion Criteria:
- Follow-up data not obtained at Wuhan Union Hospital
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
---|---|
bladder cancer, conduit diversion
new patients with bladder cancer scheduled for radical cystectomy and subsequent conduit diversion
|
All eligible patients who agree to participate will be asked to fulfill three different validated health-related quality of life questionnaires (EORTC-QLQ-C30/BLM, FACT-BL and BCI) prior to surgery and at 3, 6, 12, 18 months postoperatively.
|
bladder cancer, orthotopic neobladder
new patients with bladder cancer scheduled for radical cystectomy and subsequent orthotopic neobladder
|
All eligible patients who agree to participate will be asked to fulfill three different validated health-related quality of life questionnaires (EORTC-QLQ-C30/BLM, FACT-BL and BCI) prior to surgery and at 3, 6, 12, 18 months postoperatively.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Change from baseline in HRQoL of bladder cancer patients with different types of urinary diversions
Tidsramme: Preoperative baseline and 3, 6, 12, 18 months postoperatively
|
Preoperative baseline and 3, 6, 12, 18 months postoperatively
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Score differences between the two groups of patients in the relevant domains from three various validated tools of HRQoL
Tidsramme: Preoperative baseline and 3, 6, 12, 18 months postoperatively
|
The aim is to compare three various validated tools of HRQoL to study their relative contributions in accounting for variance in prediction of patient HRQoL. The three validated tools of HRQoL are EORTC-QLQ-C30/BLM (The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire/bladder cancer module), FACT-BL (Functional Assessment of Cancer Therapy-Bladder cancer) and BCI (Bladder Cancer Index). The two groups are conduit diversion group and orthotopic neobladder group. |
Preoperative baseline and 3, 6, 12, 18 months postoperatively
|
Score changes of each patient group during the follow-up
Tidsramme: Preoperative baseline and 3, 6, 12, 18 months postoperatively
|
Longitudinally learn about the changes of each individual patient HRQoL after urinary diversion and compare the changes of two groups, i.e. conduit diversion group and orthotopic neobladder group.
|
Preoperative baseline and 3, 6, 12, 18 months postoperatively
|
Objective examination outcomes
Tidsramme: Preoperative baseline and 3, 6, 12, 18 months postoperatively
|
Supplement the assessment by interviewing the patients with some lab and image examinations, such as renal function tests, liver function tests, urine culture, urine cytology, chest radiography, ultrasound of kidney, ureter and bladder (KUB) etc.
|
Preoperative baseline and 3, 6, 12, 18 months postoperatively
|
Samarbejdspartnere og efterforskere
Efterforskere
- Studieleder: Xiaoping Zhang, MD, PhD, Department of Urology, Wuhan Union Hospital, Huazhong University of Science and Technology
- Ledende efterforsker: Hangchuan Shi, MD, Department of Urology, Wuhan Union Hospital, Huazhong University of Science and Technology
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 01-18-530605
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