UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036988 |
|---|---|
| Receipt number | R000042134 |
| Scientific Title | What should we do to improve health-related quality of life in multiple myeloma patients? |
| Date of disclosure of the study information | 2019/06/06 |
| Last modified on | 2021/06/08 14:09:06 |
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Basic information
Public title
What should we do to improve health-related quality of life in multiple myeloma patients?
Acronym
What should we do to improve health-related quality of life in multiple myeloma patients?
Scientific Title
What should we do to improve health-related quality of life in multiple myeloma patients?
Scientific Title:Acronym
What should we do to improve health-related quality of life in multiple myeloma patients?
Region
| Japan |
Condition
Condition
multiple myeloma
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The object is to clarify the prevalence of symptoms, trajectories of symptoms and HRQOL, and impact of symptoms on HRQOL in patients newly diagnosed with multiple myeloma, in a longitudinal observational quantity and quolity study.We would like to develop program to improve myeloma matient's HRQOL.
Basic objectives2
Others
Basic objectives -Others
Longitudinal observation survey
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
EQ-5D
Key secondary outcomes
MDASI
PHQ9
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The eligibility criteria for inclusion in the study were inpatients who (a) were newly diagnosed with MM, (b)intended to undergo chemotherapy and go into either Nagoya City Universal Hospital or Kainan Hospital or Nagoya Memorial Hospital or Nagoya City West Medical Center, (c)were over 20 years, (d)were the ability to understand the Japanese language.
Key exclusion criteria
The exclusion criteria were patients with (a) clinically diagnosed severe mental or cognitive disorders and/or (b) not enough to complete the survey questionnaire by primary care doctor
Target sample size
130
Research contact person
Name of lead principal investigator
| 1st name | Toru |
| Middle name | |
| Last name | Okuyama |
Organization
Nagoya City University Hospital
Division name
Division of Psycho-oncology and Palliative Care
Zip code
467-8601
Address
Mizuho-cho, Mizuho-ku, Nagoya, Aichi 467-8601 Japan
TEL
052-851-5511
okuyama@med.nagoya-cu.ac.jp
Public contact
Name of contact person
| 1st name | Nana |
| Middle name | |
| Last name | Suzuki |
Organization
Nagoya City University Hospital
Division name
Palliative Care
Zip code
467-8601
Address
Mizuho-cho, Mizuho-ku, Nagoya, Aichi 467-8601 Japan
TEL
052-851-5511
Homepage URL
rakkaryu.sui.77@gmail.com
Sponsor or person
Institute
Nagoya City University
Institute
Department
Personal name
Funding Source
Organization
Nagoya City University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagoya City University Hospital
Address
Mizuho-cho, Mizuho-ku, Nagoya, Aichi 467-8601 Japan
Tel
0528515511
rakkaryu.sui.77@gmail.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
| 2019 | Year | 06 | Month | 06 | 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
106
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
No longer recruiting
Date of protocol fixation
| 2019 | Year | 03 | Month | 15 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 15 | Day |
Anticipated trial start date
| 2019 | Year | 03 | Month | 15 | Day |
Last follow-up date
| 2021 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
| 2021 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2021 | Year | 04 | Month | 30 | Day |
Date analysis concluded
| 2021 | Year | 07 | Month | 30 | Day |
Other
Other related information
We will do this survey with the questionnaire in multiple myeloma patients. In the questionnaire, we will check QOL, MDASI,PHQ-9.
Management information
Registered date
| 2019 | Year | 06 | Month | 06 | Day |
Last modified on
| 2021 | Year | 06 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042134
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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