UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Influence of social determinants of health in patients with advanced lung cancer: a prospective cohort study
Title of the study (Brief title)	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	Yuki Kataoka
Organization	Hyogo Prefectural Amagasaki General Medical Center
Division name	Department of Respiratory Medicine
Address	2-17-77, Higashi Naniwacho, Amagasaki, Hyogo
TEL	06-6480-7000
Email	hanshin.crt@gmail.com

Public contact
Name of contact person	Yuki Kataoka
Organization	Hyogo Prefectural Amagasaki General Medical Center
Division name	Department of Respiratory Medicine
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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2018 Year 02 Month 20 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000036325