UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035399
Receipt number R000040334
Scientific Title Survey of costs and QOL for patients undergoing outpatient chemotherapy
Date of disclosure of the study information 2018/12/28
Last modified on 2018/12/28 19:42:40

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Basic information

Public title

Survey of costs and QOL for patients undergoing outpatient chemotherapy

Acronym

Survey of costs and QOL

Scientific Title

Survey of costs and QOL for patients undergoing outpatient chemotherapy

Scientific Title:Acronym

Survey of costs and QOL

Region

Japan


Condition

Condition

Breast cancer

Classification by specialty

Breast surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Expense and QOL investigation by pharmacist involvement

Basic objectives2

Others

Basic objectives -Others

cost

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

QOL score

Key secondary outcomes



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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Breast cancer patients who received their first course of intravenous chemotherapy at Gifu Municipal Hospital.

Key exclusion criteria

The patients received hormone therapy, only oral anti-cancer drug treatment or radiation therapy.

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kazuhide Tanaka

Organization

Gifu Municipal Hospital

Division name

Department of Pharmacy

Zip code


Address

7-1 kashima-cho, Gifu-shi, Gifu, Japan

TEL

+81-58-251-1101

Email

k-tanaka@gmhosp.gifu.gifu.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kazuhide Tanaka

Organization

Gifu Municipal Hospital

Division name

Department of Pharmacy

Zip code


Address

7-1 kashima-cho, Gifu-shi, Gifu, Japan

TEL

+81-58-251-1101

Homepage URL


Email

k-tanaka@gmhosp.gifu.gifu.jp


Sponsor or person

Institute

Gifu Municipal Hospital

Institute

Department

Personal name



Funding Source

Organization

Gifu Municipal Hospital

Organization

Division

Category of Funding Organization

Local Government

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

2018 Year 12 Month 28 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

Completed

Date of protocol fixation

2013 Year 11 Month 01 Day

Date of IRB


Anticipated trial start date

2013 Year 12 Month 11 Day

Last follow-up date

2016 Year 01 Month 31 Day

Date of closure to data entry

2016 Year 03 Month 31 Day

Date trial data considered complete

2016 Year 05 Month 31 Day

Date analysis concluded

2016 Year 11 Month 30 Day


Other

Other related information

OQL is higher in the group with pharmacist involvement.
Cost effect does not exceed threshold.


Management information

Registered date

2018 Year 12 Month 28 Day

Last modified on

2018 Year 12 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040334


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name
2018/12/28 QALY_Upload.xlsx