UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012932
Receipt number R000015108
Scientific Title Changes in quality of life through the early intervention by palliative care team for patients with advanced lung cancer
Date of disclosure of the study information 2014/01/25
Last modified on 2014/01/23 19:01:06

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Changes in quality of life through the early intervention by palliative care team for patients with advanced lung cancer

Acronym

Changes in quality of life through the early intervention by palliative care team for patients with advanced lung cancer

Scientific Title

Changes in quality of life through the early intervention by palliative care team for patients with advanced lung cancer

Scientific Title:Acronym

Changes in quality of life through the early intervention by palliative care team for patients with advanced lung cancer

Region

Japan


Condition

Condition

lung cancer

Classification by specialty

Medicine in general Pneumology Hematology and clinical oncology
Psychosomatic Internal Medicine Geriatrics Psychiatry

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The improvement in quality of life (QOL) by a palliative care team intervention was analyzed in patients with advanced lung cancer. An evaluation of QOL by the patients was compared with its estimation by the attending physicians.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

The primary endpoint is the difference between the QOL that was assessed by the EORTC QLQ c-15-PAL after 12 weeks after the start of the test and at the beginning of the study.

Key secondary outcomes

Secondary endpoint is the change of each QOL item and an evaluation of QOL by the patients was compared with its estimation by the attending physicians.


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Behavior,custom

Interventions/Control_1

The attending physician will follow-up items of two points from 1 with OPTIM published"STEP palliative care". Attending physician to perform the consultation the PCT if the patient's symptoms were exacerbated. Palliative care team to follow-up items four points from three. Patients make an appointment with the palliative physician, Palliative physician to determine the contents of treatment and the need for specialized outpatient consult.We will do the intervention of one or more times to a minimum one month after the start of the test. We will end the investigation by evaluating the QOL survey again to attending physician and the patient himself after 12 weeks.Patients can choose stop and continued follow-up of 12 weeks.

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

1.Patients 20 years old or more.
2.Newly diagnosed patients with stage 4 lung cancer.
3.PS of Eastern Cooperative Oncology Group is 0 to 3.
4.Patients can be expected survival of more than a month.

Key exclusion criteria

1.There is a depression at the start of the test time is patient.
2. It is not possible for the patient to understand Japanese.
3.Patient is not able to visit once a month to our hospital.
4.If the attending physician was deemed inappropriate to participate in the study.

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kunikane Hiroshi

Organization

Yokohama Municipal Citizen Hospital

Division name

Department of Palliative Medicine

Zip code


Address

56 Okazawa-cho Hodogaya-ku yokohama-shi Kanagawa-ken Japan

TEL

045-331-1961

Email

taroman045@gmail.com


Public contact

Name of contact person

1st name
Middle name
Last name Taro Yokoyama

Organization

Yokohama Municipal Citizen Hospital

Division name

Department of Palliative Medicine

Zip code


Address

56 Okazawa-cho Hodogaya-ku yokohama-shi Kanagawa-ken Japan

TEL

045-331-1961

Homepage URL


Email

taroman045@gmail.com


Sponsor or person

Institute

Yokohama Municipal Citizen Hospital Department of Palliative Medicine

Institute

Department

Personal name



Funding Source

Organization

Yokohama Municipal Citizen Hospital Department of Palliative Medicine

Organization

Division

Category of Funding Organization

Local Government

Nationality of Funding Organization



Other related organizations

Co-sponsor

Yokohama Municipal Citizens Hospital Department of Respiratory Palliative Medicine Yokohama Municipal Citizens Hospital Department of Medical Oncology Medicine

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

2014 Year 01 Month 25 Day


Related information

URL releasing protocol


Publication of results

Partially published


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

2011 Year 08 Month 29 Day

Date of IRB


Anticipated trial start date

2011 Year 10 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2014 Year 01 Month 23 Day

Last modified on

2014 Year 01 Month 23 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015108


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name