UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000056654
Receipt number R000064463
Scientific Title Influence of the medical care system in a hematology ward on patient quality of life and anxiety
Date of disclosure of the study information 2025/01/14
Last modified on 2025/01/07 21:32:56

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Basic information

Public title

Influence of the medical care system in a hematology ward on patient quality of life and anxiety

Acronym

Influence of the medical care system in a hematology ward on patient quality of life and anxiety

Scientific Title

Influence of the medical care system in a hematology ward on patient quality of life and anxiety

Scientific Title:Acronym

Influence of the medical care system in a hematology ward on patient quality of life and anxiety

Region

Japan


Condition

Condition

hematology

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Investigation of factors affecting patient quality of life and anxiety

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

quality of life and anxiety

Key secondary outcomes

cost effectiveness


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

18 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients admitted to the hematology ward and starting chemotherapy during the study period.
Patients who are able to answer the questionnaire survey.
Patients who can give consent to participate in this study.

Key exclusion criteria

Patients under 18 years old.
Patients who are unable to respond to the questionnaire.
Patients whom the investigator determines are not appropriate to participate in the study.

Target sample size

200


Research contact person

Name of lead principal investigator

1st name Masahiro
Middle name
Last name Yasuda

Organization

Gifu Municipal Hospital

Division name

Department of Pharmacy

Zip code

500-8513

Address

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

TEL

+81-58-251-1101

Email

m.yasuda@gmhosp.gifu.gifu.jp


Public contact

Name of contact person

1st name Kazuhide
Middle name
Last name Tanaka

Organization

Gifu Municipal Hospital

Division name

Department of Pharmacy

Zip code

500-8513

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

Gifu Municipal Hospital Clinical Research Review Board

Address

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

Tel

+81-58-251-1101

Email

kenkyu@gmhosp.gifu.gifu.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

2025 Year 01 Month 14 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

Preinitiation

Date of protocol fixation

2024 Year 12 Month 23 Day

Date of IRB


Anticipated trial start date

2025 Year 01 Month 14 Day

Last follow-up date

2026 Year 01 Month 13 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Nothing


Management information

Registered date

2025 Year 01 Month 07 Day

Last modified on

2025 Year 01 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064463