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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000031810
Receipt No. R000036325
Scientific Title Influence of social determinants of health in patients with advanced lung cancer: a prospective cohort study
Date of disclosure of the study information 2018/03/20
Last modified on 2018/09/19

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Basic information
Public title Influence of social determinants of health in patients with advanced lung cancer: a prospective cohort study
Acronym Influence of social determinants of health in patients with advanced lung cancer
Scientific Title Influence of social determinants of health in patients with advanced lung cancer: a prospective cohort study
Scientific Title:Acronym Influence of social determinants of health in patients with advanced lung cancer
Region
Japan

Condition
Condition advanced lung cancer
Classification by specialty
Medicine in general Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 to assess the effects of SDH on patients with advanced lung cancer in Japan
Basic objectives2 Others
Basic objectives -Others To explore the relationship between exposures and outcomes
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes initial treatment
Key secondary outcomes rout to diagnosis, overall survival, stage of cancer progression and performance status at the time of enrolment, and place of death

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. A pathological or clinical diagnosis of lung cancer
2. Willingness to provide written informed consent for enrolment in the study
3. Unsuitability for curative surgery
4. Previously untreated or within 2 months of starting treatment for newly diagnosed lung cancer.
Key exclusion criteria 1. Inability to complete a study questionnaire because of dementia or mental illness
2. Unsuitable for participation in the study in the opinion of the attending physician.
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuki Kataoka
Organization Hyogo Prefectural Amagasaki General Medical Center
Division name Department of Respiratory Medicine
Zip code
Address 2-17-77, Higashi Naniwacho, Amagasaki, Hyogo
TEL 06-6480-7000
Email hanshin.crt@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Yuki Kataoka
Organization Hyogo Prefectural Amagasaki General Medical Center
Division name Department of Respiratory Medicine
Zip code
Address 2-17-77, Higashi Naniwacho, Amagasaki, Hyogo
TEL 06-6480-7000
Homepage URL
Email hanshin.crt@gmail.com

Sponsor
Institute Hyogo Prefectural Amagasaki General Medical Center
Institute
Department

Funding Source
Organization Hyogo Prefectural Amagasaki General Medical Center
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
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 兵庫県立尼崎総合医療センター

Other administrative information
Date of disclosure of the study information
2018 Year 03 Month 20 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 Enrolling by invitation
Date of protocol fixation
2018 Year 02 Month 20 Day
Date of IRB
Anticipated trial start date
2018 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The variables evaluated in this study will be social isolation, loneliness, employment, social security income, education, dementia, smoking history, weight loss, respiratory symptoms, tissue type, mutation status (epidermal growth factor receptor, anaplastic lymphoma kinase, ROS1), and programmed death-ligand 1 status.
Social isolation will be surveyed using the Japanese short version of the Lubben Social Network Scale (LSNS-6).Loneliness will be surveyed using the Japanese Version 3 of the UCLA (University of California, Los Angeles) Loneliness Scale.

Management information
Registered date
2018 Year 03 Month 20 Day
Last modified on
2018 Year 09 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036325

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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