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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034953
Receipt No. R000039854
Official scientific title of the study 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 2018/11/20

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Basic information
Official scientific title of the study Development of "COmprehensive Score for financial Toxicity (COST) tool" and Financial Toxicity for patients with Gynecologic cancer during chemotherapy in Japan
Title of the study (Brief title) J-COST 01
Region
Japan

Condition
Condition Gynecologic cancer
Classification by specialty
Obsterics 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 Yusuke Kajimoto
Organization The University of Tokyo
Division name Department of Health Economics and Outcomes Research, Graduate School of Pharmaceutical Sciences
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL 03-5841-4702
Email ykajimoto234@g.ecc.u-tokyo.ac.jp

Public contact
Name of contact person Yusuke Kajimoto
Organization The University of Tokyo
Division name Department of Health Economics and Outcomes Research, Graduate School of Pharmaceutical Sciences
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL 03-5841-4702
Homepage URL
Email ykajimoto234@g.ecc.u-tokyo.ac.jp

Sponsor
Institute The University of Tokyo
Institute
Department

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
Saitama Medical University Internal Medical Center
Name of secondary funder(s)

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)、埼玉医科大学国際医療センター(埼玉県)

Other administrative information
Date of disclosure of the study information
2018 Year 12 Month 01 Day

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 11 Month 05 Day
Anticipated trial start date
2018 Year 12 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

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information Study using questionnaires

Management information
Registered date
2018 Year 11 Month 20 Day
Last modified on
2018 Year 11 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039854

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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