UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051704 |
|---|---|
| Receipt number | R000059006 |
| Scientific Title | A pilot randomized controlled trial of standard palliative care vs. early palliative care using a care program focusing on individual concerns in patients with advanced lung cancer and their caregivers |
| Date of disclosure of the study information | 2023/08/01 |
| Last modified on | 2023/10/07 14:14:11 |
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Basic information
Public title
A pilot randomized controlled trial of standard palliative care vs. early palliative care using a care program focusing on individual concerns in patients with advanced lung cancer and their caregivers
Acronym
A pilot randomized controlled trial of standard palliative care vs. early palliative care using a care program focusing on individual concerns in patients with advanced lung cancer and their caregivers
Scientific Title
A pilot randomized controlled trial of standard palliative care vs. early palliative care using a care program focusing on individual concerns in patients with advanced lung cancer and their caregivers
Scientific Title:Acronym
A pilot randomized controlled trial of standard palliative care vs. early palliative care using a care program focusing on individual concerns in patients with advanced lung cancer and their caregivers
Region
| Japan |
Condition
Condition
advanced lung cancer
Classification by specialty
| Pneumology | Hematology and clinical oncology | Nursing |
| Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We examine feasibility, acceptability and effectiveness of early palliative care using a care program focusing on individual concerns in patients with advanced lung cancer and their caregivers in comparison with standard palliative care in a pilot randomized controlled trial.
Basic objectives2
Others
Basic objectives -Others
feasibility, acceptability and effectiveness
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We assess the feasibility using recruitment rates and meeting rates.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Standard care
Interventions/Control_2
Early palliative care using a care program focusing on individual concerns in patients and their caregivers
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 are eligible if they are (a) newly diagnosed with clinical stage IV lung cancer and (b) 20 years of age or older.
Caregivers are eligible if they are (a) identified by the patients as their primary caregiver and (b) 20 years of age or older.
Key exclusion criteria
Exclusion criteria are the following: patients who (a) are unable to write and comprehend Japanese, (b) had significant cognitive impairment or (c) have already received anticancer treatments (chemotherapy, radiation, surgery, or immunotherapy). Caregivers are not eligible if they (a) are unable to write and comprehend Japanese or (b) had significant cognitive impairment.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Katsuhiko |
| Middle name | |
| Last name | Naoki |
Organization
Kitasato University School of Medicine
Division name
Department of Respiratory Medicine
Zip code
252-0374
Address
1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa
TEL
0427788111
knaoki@kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Sato |
Organization
Kitasato University School of Medicine
Division name
Department of Respiratory Medicine
Zip code
252-0374
Address
1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa
TEL
0427788111
Homepage URL
tsato@med.kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University
Institute
Department
Personal name
Funding Source
Organization
Kitasato University School of Medicine
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
Kitasato University School of Medicine
Address
1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa
Tel
0427788111
rinri@med.kitasato-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
| 2023 | Year | 08 | Month | 01 | 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
| 2023 | Year | 07 | Month | 21 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 07 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 03 | Day |
Last follow-up date
| 2025 | 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
| 2023 | Year | 07 | Month | 24 | Day |
Last modified on
| 2023 | Year | 10 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059006
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
