Bladder CancerNCT02174185
Compare the Quality of Life Between Patients With Conduit Diversions or Orthotopic Neobladders
An observational study of Bladder Cancer, run by Huazhong University of Science and Technology at 1 site in China.
Trial summary
The aim of this study is to compare the health-related quality of life (HRQoL) between patients underwent conduit diversion and orthotopic neobladder after radical cystectomy. The investigators plan to use validated HRQoL questionnaires to learn about how the different urinary diversion operations affect the HRQoL of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- validated health-related quality of life questionnaires
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- Aug 2014to Aug 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All eligible patients in Wuhan Union Hospital, Huazhong University of Science and Technology.
Who may be able to join
- 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
Who cannot join
- Follow-up data not obtained at Wuhan Union Hospital
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Urology, Wuhan Union Hospital, Huazhong University of Science and Technology
Wuhan, Hubei, 430022
Xiaoping Zhang, MD, PhD, 86 27 85351625, xzhang@hust.edu.cn
Hangchuan Shi, MD, 86 13098893958, hangchuan_shi@hust.edu.cn
About this study
Official title: A Prospective and Comparative Study of Health-related Quality of Life (HRQoL) in Patients With Conduit Diversion or Orthotopic Neobladder
The aim of this study is to compare the health-related quality of life (HRQoL) between patients underwent conduit diversion and orthotopic neobladder after radical cystectomy. The investigators plan to use validated HRQoL questionnaires to learn about how the different urinary diversion operations affect the HRQoL of people living with bladder cancer. The findings from this study may help doctors and patients choosing the proper operation type.
- Conditions
- Bladder Cancer
- Being tested
- validated health-related quality of life questionnaires
- Keywords
- bladder cancer, conduit diversion, orthotopic neobladder, health-related quality of life, validated questionnaire
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
validated health-related quality of life questionnairesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| bladder cancer, conduit diversion | new patients with bladder cancer scheduled for radical cystectomy and subsequent conduit diversion Receives: Behavioral: validated health-related quality of life questionnaires | |
| bladder cancer, orthotopic neobladder | new patients with bladder cancer scheduled for radical cystectomy and subsequent orthotopic neobladder Receives: Behavioral: validated health-related quality of life questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in HRQoL of bladder cancer patients with different types of urinary diversions
Measured: Preoperative baseline and 3, 6, 12, 18 months postoperatively
Secondary outcomes (3)
Score differences between the two groups of patients in the relevant domains from three various validated tools of HRQoL
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.
Measured: Preoperative baseline and 3, 6, 12, 18 months postoperatively
Score changes of each patient group during the follow-up
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.
Measured: Preoperative baseline and 3, 6, 12, 18 months postoperatively
Objective examination outcomes
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.
Measured: Preoperative baseline and 3, 6, 12, 18 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2014 (estimated)
- Study startAug 2014
- Primary completionAug 2018 (estimated)
- Study completionAug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhang Xiaoping, Huazhong University of Science and Technology
- Investigators
- Xiaoping Zhang, MD, PhD, Study director, Department of Urology, Wuhan Union Hospital, Huazhong University of Science and TechnologyHangchuan Shi, MD, Principal investigator, Department of Urology, Wuhan Union Hospital, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02174185
- Sponsor's protocol ID
- 01-18-530605
- Status last verified
- Aug 2014
- First submitted
- 22 Jun 2014
- Last updated
- 4 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective and Comparative Study of Health-related Quality of Life (HRQoL) in Patients With Conduit Diversion or Orthotopic Neobladder
- ClinicalTrials.gov ID
- NCT02174185
- Acronym / sponsor ID
- 01-18-530605
- Conditions
- Bladder Cancer
- Keywords
- bladder cancer, conduit diversion, orthotopic neobladder, health-related quality of life, validated questionnaire
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Aug 2018 (estimated)
- Study completion
- Aug 2018 (estimated)
- First posted
- 25 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to compare the health-related quality of life (HRQoL) between patients underwent conduit diversion and orthotopic neobladder after radical cystectomy. The investigators plan to use validated HRQoL questionnaires to learn about how the different urinary diversion operations affect the HRQoL of people living with bladder cancer. The findings from this study may help doctors and patients choosing the proper operation type.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| bladder cancer, conduit diversion | – | Behavioral: validated health-related quality of life questionnairesnew patients with bladder cancer scheduled for radical cystectomy and subsequent conduit diversion |
| bladder cancer, orthotopic neobladder | – | Behavioral: validated health-related quality of life questionnairesnew patients with bladder cancer scheduled for radical cystectomy and subsequent orthotopic neobladder |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All eligible patients in Wuhan Union Hospital, Huazhong University of Science and Technology.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Follow-up data not obtained at Wuhan Union Hospital
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| validated health-related quality of life questionnairesAll 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. | Behavioural | bladder cancer, conduit diversion, bladder cancer, orthotopic neobladder |
Primary outcome
Change from baseline in HRQoL of bladder cancer patients with different types of urinary diversions
Time frame: Preoperative baseline and 3, 6, 12, 18 months postoperatively
3 secondary outcomes
Score differences between the two groups of patients in the relevant domains from three various validated tools of HRQoL
Time frame: Preoperative baseline and 3, 6, 12, 18 months postoperatively
Score changes of each patient group during the follow-up
Time frame: Preoperative baseline and 3, 6, 12, 18 months postoperatively
Objective examination outcomes
Time frame: Preoperative baseline and 3, 6, 12, 18 months postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiaoping Zhang, MD, PhD study director
Department of Urology, Wuhan Union Hospital, Huazhong University of Science and Technology
Hangchuan Shi, MD principal investigator
Department of Urology, Wuhan Union Hospital, Huazhong University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bladder Cancer, run by Huazhong University of Science and Technology at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaoping Zhang, MD, PhD (86 27 85351625, xzhang@hust.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in HRQoL of bladder cancer patients with different types of urinary diversions (time frame: Preoperative baseline and 3, 6, 12, 18 months postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2014.