UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000044561
Receipt number R000050803
Scientific Title Relationship between symptom clusters and independence in elderly lung cancer patients receiving chemotherapy: a longitudinal study
Date of disclosure of the study information 2021/06/20
Last modified on 2021/12/15 14:02:19

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Basic information

Public title

Relationship between symptom clusters and independence in elderly lung cancer patients receiving chemotherapy: a longitudinal study

Acronym

Relationship between symptom clusters and independence in elderly lung cancer patients receiving chemotherapy: a longitudinal study

Scientific Title

Relationship between symptom clusters and independence in elderly lung cancer patients receiving chemotherapy: a longitudinal study

Scientific Title:Acronym

Relationship between symptom clusters and independence in elderly lung cancer patients receiving chemotherapy: a longitudinal study

Region

Japan


Condition

Condition

lung cancer

Classification by specialty

Nursing

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To investigate the relationship between symptom clusters and independence in elderly lung cancer patients receiving chemotherapy.

Basic objectives2

Others

Basic objectives -Others

Symptom clusters, Independence, Quality Of Life(QOL)

Trial characteristics_1


Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

Relationship between symptom clusters and independence

Key secondary outcomes

-Symptom clusters
-Independence
-Quality Of Life(QOL)


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

65 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

-Who with a diagnosis of advanced or recurrent lung cancer
-receiving chemotherapy
-at the time or regimen change

Key exclusion criteria

Who can not read or write Japanese

Target sample size

110


Research contact person

Name of lead principal investigator

1st name Kaori
Middle name
Last name Yagasaki

Organization

Keio University

Division name

Faculty of Nursing and Medical Care

Zip code

160-8582

Address

35 Shinanomachi, Shinjuku-ku, Tokyo

TEL

03-5363-2157

Email

yagasaki@sfc.keio.ac.jp


Public contact

Name of contact person

1st name Kaori
Middle name
Last name Yagasaki

Organization

Keio University

Division name

Faculty of Nursing and Medical Care

Zip code

160-8582

Address

35 Shinanomachi, Shinjuku-ku, Tokyo

TEL

03-5363-2157

Homepage URL


Email

yagasaki@sfc.keio.ac.jp


Sponsor or person

Institute

Faculty of Nursing and Medical Care, Keio University

Institute

Department

Personal name



Funding Source

Organization

Keio University

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Keio University School of Medicine Ethics Committee

Address

35 Shinanomachi, Shinjuku-ku, Tokyo

Tel

03-3353-1211

Email

med-rinri-jimu@adst.keio.ac.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

慶應義塾大学病院(東京都)


Other administrative information

Date of disclosure of the study information

2021 Year 06 Month 20 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

Open public recruiting

Date of protocol fixation

2021 Year 05 Month 25 Day

Date of IRB

2021 Year 05 Month 25 Day

Anticipated trial start date

2021 Year 07 Month 01 Day

Last follow-up date

2024 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

This is a 3 months longitudinal study using the questionnaires to observe symptoms, independence, and QOL.
The subjects are outpatients or inpatients who meet the inclusion criteria.
Data will be collected at three time points: at the time of regimen change, two weeks after chemotherapy, and three months after chemotherapy.


Management information

Registered date

2021 Year 06 Month 16 Day

Last modified on

2021 Year 12 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050803


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name