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
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
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
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
