UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000026436
Receipt number R000028920
Scientific Title Investigation for advanced cancer patients' treatment preferences and their end of life care
Date of disclosure of the study information 2017/04/01
Last modified on 2021/09/09 11:10:18

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Basic information

Public title

Investigation for advanced cancer patients' treatment preferences and their end of life care

Acronym

Investigation for advanced cancer patients' treatment preferences and their end of life care

Scientific Title

Investigation for advanced cancer patients' treatment preferences and their end of life care

Scientific Title:Acronym

Investigation for advanced cancer patients' treatment preferences and their end of life care

Region

Japan


Condition

Condition

advanced cancer

Classification by specialty

Pneumology Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

1) to explore the associations between end-of-life discussion and quality of life, end-of-life care consistent with preferences, to investigate characteristics of patients willing to have end-of-life discussion
2) to explore the associations between beliefs about the effectiveness of chemotherapy and end-of-life care consistent with preferences, to explore factors influencing inaccurate expectations about the curative potential of chemotherapy
3) to investigate characteristics of patients received chemotherapy near death
4) to explore whether the willingness of the care giver for the end-of-life discussion matches the willingness of the patient, to explore the associations between care giver's intent and the quality of end-of-life
5) to explore the associations between good death in patients and good death in physician, to explore factors influencing concordance of good death

Basic objectives2

Others

Basic objectives -Others

Longitudinal observation survey

Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Comprehensive Quality of Life Outcome inventory (CoQoLo) at 3 months

Key secondary outcomes

PHQ-9 at 3months
End of life treatment received
Receipt of care consistent with preferences
End of life discussion
Good death in patient
Good death in care giver
Good death in physician
Metacognitive Awareness Scale
Beliefs about the effectiveness of chemotherapy
Physician compassion scale


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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

patients with advanced cancer and their primary caregiver

1. cancer with distant metastases
2. failure of first-line chemotherapy
3. treated in the participating institutions during the study period
4. 20 years of age or older
5. able to understand the Japanese language
6. in longitudinal observational study,patients were required to meet the following criteria: diagnosis of Stage IIIB or IV disease and failure of first-line chemotherapy within 2 months

Key exclusion criteria

1. physically too ill to complete the questionnaire
2. severe mental disorders
3. severe cognitive disorders
4. judged by the treating physician to be unsuitable to participate

Target sample size

400


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Toru Okuyama

Organization

Nagoya City University Hospital

Division name

Division of Palliative Care and Psycho-oncology

Zip code


Address

Mizuho-cho, Mizuho-ku, Nagoya, Aichi, Japan

TEL

052-851-5511

Email

okuyama@med.nagoya-cu.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Takaaki Hasegawa

Organization

Nagoya City University Hospital

Division name

Division of Palliative Care and Psycho-oncology

Zip code


Address

Mizuho-cho, Mizuho-ku, Nagoya, Aichi, Japan

TEL

052-851-5511

Homepage URL


Email

takaaki_hase@bird.ocn.ne.jp


Sponsor or person

Institute

Nagoya City University

Institute

Department

Personal name



Funding Source

Organization

Ministry of Education,Culture,Sports.Science and Technology

Organization

Division

Category of Funding Organization

Japanese Governmental office

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

名古屋市立大学病院(愛知県)
名古屋市立西部医療センター(愛知県)
九州がんセンター(福岡県)
順天堂大学医学部附属順天堂東京江東高齢者医療センター(東京都)


Other administrative information

Date of disclosure of the study information

2017 Year 04 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

2017 Year 02 Month 03 Day

Date of IRB

2017 Year 03 Month 06 Day

Anticipated trial start date

2017 Year 04 Month 01 Day

Last follow-up date

2026 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

We will do this survey with the questionnaire in advanced cancer patients. In the questionnaire, we will check QOL, PHQ-9, End of life discussion, Good death, perceptions about patients' status and care, quality of care, and background information.


Management information

Registered date

2017 Year 03 Month 07 Day

Last modified on

2021 Year 09 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028920


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name