UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042868 |
|---|---|
| Receipt number | R000048920 |
| Scientific Title | A Clinical Study of the Effects of Anxiety and Treatment Side Effects on Quality of Life in Patients with Malignant Lymphoma |
| Date of disclosure of the study information | 2021/01/01 |
| Last modified on | 2024/12/17 21:18:45 |
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Basic information
Public title
A Clinical Study of the Effects of Anxiety and Treatment Side Effects on Quality of Life in Patients with Malignant Lymphoma
Acronym
A Clinical Study of the Effects of Anxiety and Treatment Side Effects on Quality of Life in Patients with Malignant Lymphoma
Scientific Title
A Clinical Study of the Effects of Anxiety and Treatment Side Effects on Quality of Life in Patients with Malignant Lymphoma
Scientific Title:Acronym
A Clinical Study of the Effects of Anxiety and Treatment Side Effects on Quality of Life in Patients with Malignant Lymphoma
Region
| Japan |
Condition
Condition
Malignant Lymphoma
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Clarify the impact of side effects and anxiety on quality of life and medical economics in patients with malignant lymphoma
Basic objectives2
Others
Basic objectives -Others
Quality of life
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Impact on quality of life and health economics
Key secondary outcomes
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Malignant lymphoma patients undergoing anticancer drug therapy
Key exclusion criteria
Patients who are unable to respond to the questionnaire
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Masahiro |
| Middle name | |
| Last name | Yasuda |
Organization
Gifu Municipal Hospital
Division name
Department of Pharmacy
Zip code
500-8513
Address
7-1 kashima-cho, Gifu-shi, Gifu, Japan
TEL
+81-58-251-1101
m.yasuda@gmhosp.gifu.gifu.jp
Public contact
Name of contact person
| 1st name | Kazuhide |
| Middle name | |
| Last name | Tanaka |
Organization
Gifu Municipal Hospital
Division name
Department of Pharmacy
Zip code
500-8513
Address
7-1 kashima-cho, Gifu-shi, Gifu, Japan
TEL
+81-58-251-1101
Homepage URL
k-tanaka@gmhosp.gifu.gifu.jp
Sponsor or person
Institute
Gifu Municipal Hospital
Institute
Department
Personal name
Funding Source
Organization
Gifu Municipal Hospital
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Gifu Pharmaceutical University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Gifu Municipal Hospital Clinical Research Review Boar
Address
7-1 kashima-cho, Gifu-shi, Gifu, Japan
Tel
+81-58-251-1101
kenkyu@gmhosp.gifu.gifu.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
| 2021 | Year | 01 | Month | 01 | 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
Main results already published
Date of protocol fixation
| 2020 | Year | 08 | Month | 31 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 31 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 01 | Month | 06 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2020 | Year | 12 | Month | 28 | Day |
Last modified on
| 2024 | Year | 12 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048920
| Research Plan | |
|---|---|
| Registered date | File name |
| 2024/03/14 | ★★血液内科副作用（岐阜市民病院倫理委員会）20200901.doc |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2024/03/13 | lymphomaQOL.xlsx |
| Research case data | |
|---|---|
| Registered date | File name |
| 2024/03/13 | lymphomaQOL.xlsx |
Single case data URL
Value
https://center6.umin.ac.jp/ice/48920
