UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040113 |
|---|---|
| Receipt number | 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 | 2023/05/16 08:01:10 |
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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
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
tsato@keiyu-hospital.com
Sponsor or person
Institute
Keiyu Hospital
Institute
Department
Personal name
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
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
Completed
Date of protocol fixation
| 2020 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 23 | Day |
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
| 2023 | Year | 05 | Month | 16 | Day |
Link to view the page
Value
https://center6.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 | |
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| Registered date | File name |
