UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025043
Receipt number 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 2019/12/02 09:42:49

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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 Masashi
Middle name
Last name Ando

Organization

Aichi Cancer Center Hospital

Division name

Department of Clinical Oncology

Zip code

4648681

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 Kazunori
Middle name
Last name Honda

Organization

Aichi Cancer Center Hospital

Division name

Department of Clinical Oncology

Zip code

464-8681

Address

Nagoya, Aichi

TEL

+81-52-762-6111

Homepage URL


Email

khonda@aichi-cc.jp


Sponsor or person

Institute

Aichi Cancer Center Hospital

Institute

Department

Personal name



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

Aichi Cancer Center Hospital

Address

1-1 Kanokoden, Chikusa-ku, Nagoya, Aichi 464-8681, Japan

Tel

+81-52-762-6111

Email

khonda@aichi-cc.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

2016 Year 11 Month 30 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

https://www.ncbi.nlm.nih.gov/pubmed/31070981

Number of participants that the trial has enrolled

156

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

Completed

Date of protocol fixation

2016 Year 11 Month 08 Day

Date of IRB

2016 Year 11 Month 08 Day

Anticipated trial start date

2016 Year 11 Month 30 Day

Last follow-up date

2019 Year 03 Month 31 Day

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

2019 Year 12 Month 02 Day



Link to view the page

Value
https://center6.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