UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035214 |
|---|---|
| Receipt number | R000040132 |
| Scientific Title | Relationship between perception of prognosis and quality of life; an observational study |
| Date of disclosure of the study information | 2018/12/11 |
| Last modified on | 2019/09/01 21:40:26 |
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Basic information
Public title
Relationship between perception of prognosis and quality of life; an observational study
Acronym
Perception of prognosis and quality of life
Scientific Title
Relationship between perception of prognosis and quality of life; an observational study
Scientific Title:Acronym
Perception of prognosis and quality of life
Region
| Japan |
Condition
Condition
Locally advanced, metastatic or recurrent malignant tumor
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the association of the discordance in perception of prognosis between oncologist and patients, and the quality of life (QOL).
Basic objectives2
Others
Basic objectives -Others
Evaluate a variety of clinical questions and confounders among topics related with perception of prognosis and QOL.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Quality adjusted life years
Key secondary outcomes
Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events
Hospital Anxiety and Depression 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
(1) Subject who are to be treated at Department of Clinical Oncology of Yamagata University Hospital, and 20 years old or older at written informed consent. Best supportive care are included in the treatment.
(2) Informed consent in writing given freely by the patients themselves for participation in the survey of this study.
(3) Patients who are able to read and understand the questionnaire, and are able to answer the questionnaire themselves.
(4) Any malignant tumor are eligible.
Key exclusion criteria
(1) Patients who are planned to undergo a treatment of a curative intent.
(2) Patients who are unable to answer the Japanese questionnaire.
(3) A patient considered to be inappropriate by the investigator.
(4) Past personal history of depression.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Yoshioka |
Organization
Yamagata University Faculty of Medicine
Division name
Department of Clinical Oncology
Zip code
990-9585
Address
2-2-2, Iidanishi, Yamagata city, Yamagata
TEL
023-628-5224
ytakashi@med.id.yamagata-u.ac.jp
Public contact
Name of contact person
| 1st name | Sho |
| Middle name | |
| Last name | Nakamura |
Organization
Yamagata University Hospital
Division name
Department of Clinical Oncology
Zip code
990-9585
Address
2-2-2, Iidanishi, Yamagata city, Yamagata
TEL
023-628-5224
Homepage URL
sho-nakamura@umin.org
Sponsor or person
Institute
Yamagata University, Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
Self-funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yamagata University Faculty of Medicine Institutional Review Board
Address
2-2-2, Iidanishi, Yamagata, Yamagata, Japan
Tel
023-628-5047
kekenkyu@jm.kj.yamagata-u.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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 12 | Month | 11 | 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
5
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
Terminated
Date of protocol fixation
| 2018 | Year | 10 | Month | 15 | Day |
Date of IRB
| 2018 | Year | 10 | Month | 15 | Day |
Anticipated trial start date
| 2018 | Year | 12 | Month | 11 | Day |
Last follow-up date
| 2019 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Further evaluation on personality by big five inventory, psychological traits, blood examination (complete blood count, serum protein, albumin, CRP, LDH, tumor-markers), tumor stage (according to the topographical and morphological codes of ICD-O-3), past medical history, family history, anthropometric traits, and adverse events are pre-planned.
Management information
Registered date
| 2018 | Year | 12 | Month | 11 | Day |
Last modified on
| 2019 | Year | 09 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040132
