UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050547 |
|---|---|
| Receipt number | R000057562 |
| Scientific Title | Study of unmet needs and quality of life of patients with non-Hodgkin lymphoma |
| Date of disclosure of the study information | 2023/03/13 |
| Last modified on | 2024/09/08 10:12:12 |
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Basic information
Public title
Study of unmet needs and quality of life of patients with non-Hodgkin lymphoma
Acronym
Study of unmet needs and quality of life of patients with non-Hodgkin lymphoma
Scientific Title
Study of unmet needs and quality of life of patients with non-Hodgkin lymphoma
Scientific Title:Acronym
Study of unmet needs and quality of life of patients with non-Hodgkin lymphoma
Region
| Japan |
Condition
Condition
Non-Hodgkin Lymphoma
Classification by specialty
| Hematology and clinical oncology | Nursing |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the characteristics of unmet needs and health-related quality of life and the association between unmet needs and health-related quality of life in patients with relapsed/refractory non-Hodgkin lymphoma.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Unmet needs
Key secondary outcomes
Health related quality of life
Association between unmet needs and health-related quality of life
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
1) Outpatients diagnosed with relapsed/refractory indolent lymphoma
2) Completed treatment for relapsed/refractory indolent lymphoma
3) 18 years or older at the time of diagnosis of indolent lymphoma
4) Able to speak, read and write Japanese
5) Understood and consented to the study
Key exclusion criteria
1) Who have mental disorders or cognitive impairment
2) Who is considered difficult to participate in the research by primary physician
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kaori |
| Middle name | |
| Last name | Yagasaki |
Organization
Keio University
Division name
Faculty of Nursing and Medical Care
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
03-5363-2157
yagasaki@sfc.keio.ac.jp
Public contact
Name of contact person
| 1st name | Miki |
| Middle name | |
| Last name | Sugimoto |
Organization
Keio University
Division name
Graduate School of Health Management
Zip code
252-0883
Address
4411 Endo, Fujisawa-shi, Kanagawa, Japan
TEL
0466-49-6200
Homepage URL
nakamiki@sfc.keio.ac.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
Grant-in-Aid for Scientific Research(C)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University School of Medicine
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
Tel
03-3353-1211
med-rinri-jimu@adst.keio.ac.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
慶應義塾大学病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 03 | Month | 13 | 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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 03 | Month | 07 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 07 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 27 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Cross-sectional study (mixed methods convergent design)
Management information
Registered date
| 2023 | Year | 03 | Month | 09 | Day |
Last modified on
| 2024 | Year | 09 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057562
