UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055606 |
|---|---|
| Receipt number | R000063460 |
| Scientific Title | Survey research of patient and physician communication in the treatment of newly diagnosed transplant ineligible multiple myeloma |
| Date of disclosure of the study information | 2024/09/24 |
| Last modified on | 2025/09/25 08:53:02 |
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Basic information
Public title
Survey research of patient and physician communication in the treatment of newly diagnosed transplant ineligible multiple myeloma
Acronym
Survey research of patient and physician communication in the treatment of newly diagnosed transplant ineligible multiple myeloma
Scientific Title
Survey research of patient and physician communication in the treatment of newly diagnosed transplant ineligible multiple myeloma
Scientific Title:Acronym
Survey research of patient and physician communication in the treatment of newly diagnosed transplant ineligible multiple myeloma
Region
| Japan |
Condition
Condition
newly diagnosed transplant ineligible multiple myeloma
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the current state of patient-physician communication in the treatment of NDMM both at the start of treatment and after disease control.
Basic objectives2
Others
Basic objectives -Others
To identify changes in patients' knowledge, mental status, values, treatment goals, and preferences regarding treatment decisions at the start of treatment and after disease control.
Trial characteristics_1
Others
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To investigate the current state of patient-physician communication in the treatment of NDMM both at the start of treatment and after disease control.
Key secondary outcomes
To identify changes in patients' knowledge, mental status, values, treatment goals, and preferences regarding treatment decisions at the start of treatment and after disease control.
Base
Study type
Observational
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(Patients)
The study population are those who meet all of the following items:
1.Patients who are aged 18 years or older at the time of informed consent.
2.Patients who diagnosed as multiple myeloma, started induction therapy without transplantation, are currently under observation, or have stable disease status.
3.Patients who have agreed to participate in the survey questionnaire
(Doctors)
The study population are those who meet all of the following items:
1.Hematologists who are affiliated with hospitals
2.Doctors who have diagnosed two or more cases of multiple myeloma annually
3.Doctors who have agreed to participate in the survey questionnaire
Key exclusion criteria
(Patients)
1.Patients who cannot complete responses to the questionnaire
(Doctors)
No settings
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Junpei |
| Middle name | |
| Last name | Soeda |
Organization
Takeda Pharmaceutical Company Limited.
Division name
Medical Affairs, Japan Oncology Business Unit
Zip code
103-8668
Address
2-1 -1 Nihonbashi Honcho, Chuo-ku, Tokyo JAPAN
TEL
03-3278-2111
japan.oncology.iir.office@takeda.com
Public contact
Name of contact person
| 1st name | Yuta |
| Middle name | |
| Last name | Okamura |
Organization
Takeda Pharmaceutical Company Limited.
Division name
Medical Affairs, Japan Oncology Business Unit
Zip code
103-8668
Address
2-1 -1 Nihonbashi Honcho, Chuo-ku, Tokyo JAPAN
TEL
03-3278-2111
Homepage URL
japan.oncology.iir.office@takeda.com
Sponsor or person
Institute
Takeda Pharmaceutical Company Limited.
Medical Affairs, Japan Oncology Business Unit
Institute
Department
Personal name
Funding Source
Organization
Takeda Pharmaceutical Company Limited.
Medical Affairs, Japan Oncology Business Unit
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Takeda Pharmaceutical Company Limited.
Address
2-1-1, Nihonbashi-Honcho, Chuo-ku
Tel
03-3278-2111
japan.oncology.iir.office@takeda.com
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
| 2024 | Year | 09 | Month | 24 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2024 | Year | 09 | Month | 19 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 18 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 24 | Day |
Last follow-up date
| 2024 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Survey research
Management information
Registered date
| 2024 | Year | 09 | Month | 24 | Day |
Last modified on
| 2025 | Year | 09 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063460
