UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000042868
Receipt number R000048920
Scientific Title A Clinical Study of the Effects of Anxiety and Treatment Side Effects on Quality of Life in Patients with Malignant Lymphoma
Date of disclosure of the study information 2021/01/01
Last modified on 2023/06/22 15:26:28

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Basic information

Public title

A Clinical Study of the Effects of Anxiety and Treatment Side Effects on Quality of Life in Patients with Malignant Lymphoma

Acronym

A Clinical Study of the Effects of Anxiety and Treatment Side Effects on Quality of Life in Patients with Malignant Lymphoma

Scientific Title

A Clinical Study of the Effects of Anxiety and Treatment Side Effects on Quality of Life in Patients with Malignant Lymphoma

Scientific Title:Acronym

A Clinical Study of the Effects of Anxiety and Treatment Side Effects on Quality of Life in Patients with Malignant Lymphoma

Region

Japan


Condition

Condition

Malignant Lymphoma

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Clarify the impact of side effects and anxiety on quality of life and medical economics in patients with malignant lymphoma

Basic objectives2

Others

Basic objectives -Others

Quality of life

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Impact on quality of life and health economics

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

Malignant lymphoma patients undergoing anticancer drug therapy

Key exclusion criteria

Patients who are unable to respond to the questionnaire

Target sample size

100


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

Gifu Pharmaceutical University

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Gifu Municipal Hospital Clinical Research Review Boar

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

2021 Year 01 Month 01 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

No longer recruiting

Date of protocol fixation

2020 Year 08 Month 31 Day

Date of IRB

2020 Year 08 Month 31 Day

Anticipated trial start date

2021 Year 01 Month 01 Day

Last follow-up date

2023 Year 01 Month 06 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

None


Management information

Registered date

2020 Year 12 Month 28 Day

Last modified on

2023 Year 06 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048920


Research Plan
Registered date File name
2024/03/14 ★★血液内科副作用(岐阜市民病院倫理委員会)20200901.doc

Research case data specifications
Registered date File name
2024/03/13 lymphomaQOL.xlsx

Research case data
Registered date File name
2024/03/13 lymphomaQOL.xlsx