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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000035214
Receipt No. 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

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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
Email 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
Email sho-nakamura@umin.org

Sponsor
Institute Yamagata University, Faculty of Medicine
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040132

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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