UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044560 |
|---|---|
| Receipt number | R000050887 |
| Scientific Title | Unmet needs, symptoms, and quality of life of cancer patients receiving immunotherapy : a cross-sectional study |
| Date of disclosure of the study information | 2021/06/20 |
| Last modified on | 2021/12/16 09:09:45 |
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Basic information
Public title
Unmet needs, symptoms, and quality of life of cancer patients receiving immunotherapy : a cross-sectional study
Acronym
Unmet needs, symptoms, and quality of life of cancer patients receiving immunotherapy
Scientific Title
Unmet needs, symptoms, and quality of life of cancer patients receiving immunotherapy : a cross-sectional study
Scientific Title:Acronym
Unmet needs, symptoms, and quality of life of cancer patients receiving immunotherapy
Region
| Japan |
Condition
Condition
cancer
Classification by specialty
| Nursing |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To determine the unmet needs, symptoms, and QOL of cancer patients receiving immune checkpoint inhibitors.
Basic objectives2
Others
Basic objectives -Others
To exploratory examine the relationship between the unmet needs, symptoms, and QOL.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The unmet needs
Key secondary outcomes
- Symptoms
- QOL
- The relationship between the unmet needs, symptoms, and QOL
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
- Diagnosed with cancer
- Receiving immune checkpoint inhibitor and finished at least one course, or having a treatment history with an immune checkpoint inhibitor
- Treatment with an immune checkpoint inhibitor includes, single use or an combination with chemotherapy
Key exclusion criteria
-Receiving chemoradiation therapy
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Kaori |
| Middle name | |
| Last name | Yagasaki |
Organization
Keio Unibersity
Division name
Faculty of Nursing and Medical Care
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan
TEL
03-5363-2157
yagasaki@sfc.keip.ac.jp
Public contact
Name of contact person
| 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, 160-8582, Japan
TEL
03-5363-2157
Homepage URL
yagasaki@sfc.keip.ac.jp
Sponsor or person
Institute
Faculty of Nursing and Medical Care, Keio University
Institute
Department
Personal name
Funding Source
Organization
Keio University
Organization
Division
Category of Funding Organization
Non profit foundation
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 Ethics Committee
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, 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
| 2021 | Year | 06 | Month | 20 | 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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 05 | Month | 25 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 25 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study design: Cross-sectional study
Unmet needs, symptoms, and QOL are measured using the three self-administered questionnaires. Patient characteristics are extracted from his/her medical record.
Subjects are recruited in the outpatient clinic from the academic medical center in Tokyo.
Management information
Registered date
| 2021 | Year | 06 | Month | 16 | Day |
Last modified on
| 2021 | Year | 12 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050887
