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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000040113
Receipt No. R000045676
Scientific Title Effectiveness of palliative care based on concerns among patients with advanced lung cancer and their family caregivers
Date of disclosure of the study information 2020/04/15
Last modified on 2020/04/09

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Basic information
Public title Effectiveness of palliative care based on concerns among patients with advanced lung cancer and their family caregivers
Acronym Palliative care research based on concerns among advanced lung cancer patients and their caregivers
Scientific Title Effectiveness of palliative care based on concerns among patients with advanced lung cancer and their family caregivers
Scientific Title:Acronym Palliative care research based on concerns among advanced lung cancer patients and their caregivers
Region
Japan

Condition
Condition ADVANCED LUNG CANCER
Classification by specialty
Medicine in general Pneumology Hematology and clinical oncology
Psychosomatic Internal Medicine Psychiatry Nursing
Adult
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 By palliative care approaches based on screening of concerns among patients with advanced lung cancer and their family caregivers, we aim to illuminate problems in cancer care and establish better support to them.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Japanese versions of Hospital Anxiety and Depression scale, Functional Assessment of Cancer Therapy-Lung and Short-Form 8-Item Health Survey, and the Concerns Checklist
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Palliative care based on concerns among patients with advanced lung cancer and their family caregivers
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 Patients were eligible if they were (a) newly diagnosed with clinical stage IIIB, IIIC or IV inoperable lung cancer, (b) 20 years of age or older, and (c) able to write and comprehend Japanese. Caregivers were eligible if they were (a) identified by the patients as their primary caregiver, (b) 20 years of age or older, and (c) able to write and comprehend Japanese.
Key exclusion criteria Exclusion criteria for patients were the following: patients who (a) had significant cognitive
impairment or (b) had already received anticancer treatments (chemotherapy, radiation, surgery, or immunotherapy). Caregivers were not eligible if they had significant cognitive impairment.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Takashi
Middle name
Last name Sato
Organization Keiyu Hospital
Division name Department of Medicine
Zip code 220-8521
Address 3-7-3 Nishi-ku Yokohama, Kanagawa, Japan
TEL 045-221-8181
Email tsato@keiyu-hospital.com

Public contact
Name of contact person
1st name Takashi
Middle name
Last name Sato
Organization Keiyu Hospital
Division name Department of Medicine
Zip code 220-8521
Address 3-7-3 Nishi-ku Yokohama, Kanagawa, Japan
TEL 045-221-8181
Homepage URL
Email tsato@keiyu-hospital.com

Sponsor
Institute Keiyu Hospital
Institute
Department

Funding Source
Organization Keiyu Hospital
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 Keiyu Hospital
Address 3-7-3 Nishi-ku Yokohama, Kanagawa, Japan
Tel 045-221-8181
Email shomu@keiyu-hospital.com

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 けいゆう病院(神奈川県)

Other administrative information
Date of disclosure of the study information
2020 Year 04 Month 15 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 Preinitiation
Date of protocol fixation
2020 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2020 Year 04 Month 15 Day
Last follow-up date
2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 04 Month 09 Day
Last modified on
2020 Year 04 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045676

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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