UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046978 |
|---|---|
| Receipt number | R000053592 |
| Scientific Title | Questionnaire Survey for Postoperative Urothelial Carcinoma |
| Date of disclosure of the study information | 2022/02/25 |
| Last modified on | 2023/04/26 10:17:47 |
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Basic information
Public title
Questionnaire Survey for Postoperative Urothelial Carcinoma
Acronym
Questionnaire Survey for Postoperative Urothelial Carcinoma
Scientific Title
Questionnaire Survey for Postoperative Urothelial Carcinoma
Scientific Title:Acronym
Questionnaire Survey for Postoperative Urothelial Carcinoma
Region
| Japan |
Condition
Condition
Urothelial carcinoma
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate anxiety about recurrence in urothelial carcinoma patients after cystectomy or nephroureterectomy.
Basic objectives2
Others
Basic objectives -Others
To investigate whether patients with urothelial carcinoma have anxiety through their physicians with treatment experience
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Percentage of respondents with anxiety and worry in patients underwent urothelial carcinoma surgery and the changes over time from baseline
Key secondary outcomes
Percentage of respondents with recognition about patient's anxiety and worry in patients underwent urothelial cancer surgery and the changes over times from baseline/ Willingness for adjuvant therapy in patients underwent urothelial carcinoma surgery/ The extent to which patients are conveying their anxiety to their physicians/ Actual treatment status and goals of physicians with experience of surgery for urothelial cancer
Base
Study type
Others,meta-analysis etc
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients
1.Patients aged over 20 years
2.Patients with urothelial carcinoma living in Japan who have underwent cystectomy or nephroureterectomy
3. Patients more than 3 months after cystectomy or nephroureterectomy
Physicians
Physicians who have medical license in Japan and have performed cystectomy or nephroureterectomy within 5 years
Key exclusion criteria
Patients or their family members who are engaged in a pharmaceutical, medical, or survey-related job
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Hiroki |
| Middle name | |
| Last name | Matsumoto |
Organization
Ono Pharmaceutical Co., Ltd.
Division name
Oncology Medical , Medical Affairs
Zip code
103-0023
Address
9-11, Nihonbashi-Honcho 4-Chome Chuo-ku, Tokyo
TEL
03-5640-3711
hi.matsumoto@ono.co.jp
Public contact
Name of contact person
| 1st name | Shinsuke |
| Middle name | |
| Last name | Hamamatsu |
Organization
3H Clinical Trial Co., Ltd.
Division name
Insight & Outcome Group
Zip code
171-0022
Address
1-13-23,Minamiikebukuro,Toshima-ku, Tokyo,JRE Minamiikebukuro Building 2F
TEL
03-5985-0053
Homepage URL
hamamatsu-shinsuke@3h-ct.co.jp
Sponsor or person
Institute
Ono Pharmaceutical Co., Ltd.
Bristol-Myers Squibb K.K.
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Japan Conference of Clinical Research
Address
1-13-23,Minamiikebukuro,Toshima-ku, Tokyo.
Tel
03-6868-7022
jccr-info@jccr.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 02 | Month | 25 | Day |
Related information
URL releasing protocol
Japanese Journal of Urological Surgery.March 2023 Vol. 36 No. 3
Publication of results
Published
Result
URL related to results and publications
Japanese Journal of Urological Surgery.March 2023 Vol. 36 No. 3
Number of participants that the trial has enrolled
220
Results
Patients who answered as anxious accounted for 70.9% and 49.5% before and 1 to < 2 years after operation, respectively. Surgeons thought that 91.8% of patients felt anxiety before operation, but it decreased to 26.4% 1 to < 2 years after operation. Possible cancer recurrence was the most common anxiety (before operation, 80.0%; 1 to < 2 years after operation, 56.7%). The second most common anxiety was trouble with urination (before operation, 51.8%; 1 to < 2 years after operation, 26.8%).
Results date posted
| 2022 | Year | 11 | Month | 17 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2023 | Year | 03 | Month | 01 | Day |
Baseline Characteristics
"Patient inclusion criteria: Patient must be a resident of Japan at least 20 years of age, with a history of surgery of the bladder or renal pelvis and ureter, at least 3 months after the surgery.
Patient exclusion criteria: The patient or his/her family member living together should be engaged in a job related to pharmaceutical, medical, or research.
Physician Inclusion Criteria: Must be a licensed surgeon in Japan and have undergone radical or partial cystectomy of the bladder or renal pelvis and ureter within 5 years."
Participant flow
-
Adverse events
-
Outcome measures
Primary endpoint: Patient's feeling anxious
Secondary endpoints: Physicians Patient's feeling of anxiety and patients and physicians Intention to postoperative adjuvant therapy
Exploratory endpoints: The extent to which the patient expresses his/her anxiety to the physician, actual treatment practice of the physician, and treatment goals
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 02 | Month | 08 | Day |
Date of IRB
| 2022 | Year | 02 | Month | 17 | Day |
Anticipated trial start date
| 2022 | Year | 03 | Month | 03 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 23 | Day |
Date of closure to data entry
| 2022 | Year | 03 | Month | 25 | Day |
Date trial data considered complete
| 2022 | Year | 04 | Month | 05 | Day |
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2022 | Year | 02 | Month | 22 | Day |
Last modified on
| 2023 | Year | 04 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053592
