UMIN-CTR Clinical Trial

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