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UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000025043
Receipt No. R000028817
Scientific Title Investigation on financial toxicity among cancer patients receiving chemotherapy
Date of disclosure of the study information 2016/11/30
Last modified on 2016/11/29

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Basic information
Public title Investigation on financial toxicity among cancer patients receiving chemotherapy
Acronym Financial toxicity in cancer patients
Scientific Title Investigation on financial toxicity among cancer patients receiving chemotherapy
Scientific Title:Acronym Financial toxicity in cancer patients
Region
Japan

Condition
Condition malignant tumor
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To establish Japanese translation of Comprehensive score for financial toxicity(COST) and evaluate financial toxicity among Japanese cancer patients receiving chemotherapy
Basic objectives2 Others
Basic objectives -Others To investigate factors that influence financial toxicity and association between financial toxicity and survival.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Reliability and validity of Japanese translation of Comprehensive score for financial toxicity(COST) for the evaluation of financial toxicity among Japanese cancer patients receiving chemotherapy
Key secondary outcomes Factors that influence financial toxicity
Association between financial toxicity and survival

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 Cancer patients receiving chemotherapy for at least 2 months(including neoadjuvant or adjuvant chemotherapy) in Aichi Cancer Center
Key exclusion criteria Patients deemed unable to complete questionnaire due to physical or mental conditions
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masashi Ando
Organization Aichi Cancer Center Hospital
Division name Department of Clinical Oncology
Zip code
Address 1-1 Kanokoden, Chikusa-ku, Nagoya, Aichi 464-8681, Japan
TEL +81-52-762-6111
Email mandoh@aichi-cc.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazunori Honda
Organization Aichi Cancer Center Hospital
Division name Department of Clinical Oncology
Zip code
Address 1-1 Kanokoden, Chikusa-ku, Nagoya, Aichi 464-8681, Japan
TEL +81-52-762-6111
Homepage URL
Email khonda@aichi-cc.jp

Sponsor
Institute Aichi Cancer Center Hospital
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2016 Year 11 Month 30 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
Date of protocol fixation
2016 Year 11 Month 08 Day
Date of IRB
Anticipated trial start date
2016 Year 11 Month 30 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information To evaluate reliability and validity of Comprehensive score for financial toxicity(COST). To evaluate factors that influence financial toxicity and association between financial toxicity and survival.

Management information
Registered date
2016 Year 11 Month 29 Day
Last modified on
2016 Year 11 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028817

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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