UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034953 |
|---|---|
| Receipt number | R000039854 |
| Scientific Title | Development of "COmprehensive Score for financial Toxicity (COST) tool" and Financial Toxicity for patients with Gynecologic cancer during chemotherapy in Japan |
| Date of disclosure of the study information | 2018/12/01 |
| Last modified on | 2022/11/23 23:11:42 |
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Basic information
Public title
Development of "COmprehensive Score for financial Toxicity (COST) tool" and Financial Toxicity for patients with Gynecologic cancer during chemotherapy in Japan
Acronym
J-COST 01
Scientific Title
Development of "COmprehensive Score for financial Toxicity (COST) tool" and Financial Toxicity for patients with Gynecologic cancer during chemotherapy in Japan
Scientific Title:Acronym
J-COST 01
Region
| Japan |
Condition
Condition
Gynecologic cancer
Classification by specialty
| Obstetrics and Gynecology | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
1) to clarify relation between Financial Toxicity and clinical outcome
2) to clrify relation changes over time of Financial and clinical outcome
3) to prove internal and external validity of COST questionnaire and EORTC-QLQ in Japanese gynecologic cancer patient
Basic objectives2
Others
Basic objectives -Others
Validation
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Correlation between COST score and QoL score (EQ-5D-5L, EORTC-QLQ)
Key secondary outcomes
1) validation of COST questionnaire among patient with gynecologic cancer
2) relation between COST score and each factors
3) change over time of COST score
4) validation of EORTC-QLQ among patient with gynecologic cancer
5) health economics
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
Female
Key inclusion criteria
1) ovarian cancer (high risk I, high risk stage II, stage III, stage IV, recurrence), cervix cancer (stage IV, recurrence), endometorial cancer (high risk I, high risk stage II, stage III, stage IV, recurrence) in accordance with FIGO classification
2) receiving chemotherapy more than 2 month as of IC
3) scheduling to receive chemotherapy more than 1 month from IC
4) more than 20 years old
5) judged as not eligible by physician
Key exclusion criteria
1) complication affects QoL significantly
2) difficult to answer questionnaire
3) Lack of consent ability such as dementia
4) no payment or extremely less payment for medical expense
5) judged as not appropriate by physician
Target sample size
147
Research contact person
Name of lead principal investigator
| 1st name | Yusuke |
| Middle name | |
| Last name | Kajimoto |
Organization
The University of Tokyo
Division name
Department of Health Economics and Outcomes Research, Graduate School of Pharmaceutical Sciences
Zip code
113-0033
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-5841-4702
ykajimoto234@gmail.com
Public contact
Name of contact person
| 1st name | Yusuke |
| Middle name | |
| Last name | Kajimoto |
Organization
The University of Tokyo
Division name
Department of Health Economics and Outcomes Research, Graduate School of Pharmaceutical Sciences
Zip code
113-0033
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-5841-4702
Homepage URL
ykajimoto234@gmail.com
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Aichi Cancer Center
Jichi Medical University Hospital
Saitama Medical University Internal Medical Center
Gunma university hospital
Hyogo Cancer Center
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Graduate School of Pharmacerutical Science, The University of Toklyo/Ethics committee
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo 113-0033, Japan
Tel
+81-3-5841-4702
ykajimoto234@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
愛知県がんセンター（愛知県）、自治医科大学附属病院（栃木県）、埼玉医科大学国際医療センター（埼玉県）、群馬大学医学部附属病院（群馬県）、兵庫県立がんセンター（兵庫県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 12 | 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
118
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
| 2018 | Year | 11 | Month | 05 | Day |
Date of IRB
| 2018 | Year | 12 | Month | 12 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2027 | Year | 03 | Month | 31 | Day |
Other
Other related information
Study using questionnaires
Management information
Registered date
| 2018 | Year | 11 | Month | 20 | Day |
Last modified on
| 2022 | Year | 11 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039854
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