UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056578 |
|---|---|
| Receipt number | R000064658 |
| Scientific Title | Specialized palliative care program for patients with thoracic cancer: A feasibility randomized controlled trial |
| Date of disclosure of the study information | 2025/01/06 |
| Last modified on | 2024/12/26 11:36:28 |
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Basic information
Public title
Specialized palliative care program for patients with thoracic cancer: A feasibility randomized controlled trial
Acronym
Specialized palliative care program for patients with thoracic cancer: A feasibility randomized controlled trial
Scientific Title
Specialized palliative care program for patients with thoracic cancer: A feasibility randomized controlled trial
Scientific Title:Acronym
Specialized palliative care program for patients with thoracic cancer: A feasibility randomized controlled trial
Region
| Japan |
Condition
Condition
Pretreated advanced or postoperative recurrent thoracic cancer
Classification by specialty
| Pneumology | Hematology and clinical oncology | Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We aimed to evaluate the feasibility of a Specialized palliative care program for patients with thoracic cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Completion rate of intervention one month after the randomization
Key secondary outcomes
Comprehensive Quality of Life(CoQoLo: Comprehensive Quality of Life Outcome inventory)
Feeling Heard and Understood
Quality of life(EORTC QLQ-C15: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core15)
Depressive symptom(Patient Health Questionnaire-9)
Valued Questionnaire
Perception of Goal of treatment
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
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Specialized palliative care program
Interventions/Control_2
Usual care
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
Diagnosis of advanced stage recurrent thoracic cancer
After failure of first-line chemotherapy and planned or started second-line therapy
Life expectancy of more than two months
Eastern Cooperative Oncology Group Performance Status =<2
Key exclusion criteria
Too physically ill(difficulty in transportation to visit outpatient medical facilities)
Severe mental disorders
Severe cognitive disorders
Judged by the treating physician to be unsuitable for participation
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Takaaki |
| Middle name | |
| Last name | Hasegawa |
Organization
Nagoya City University Hospital
Division name
Center for Psycho-Oncology and Palliative Care
Zip code
467-8601
Address
Kawasumi 1, Mizuho-cho, Mizuho-ku, Nagoya
TEL
052-851-5511
takaaki_hase@bird.ocn.ne.jp
Public contact
Name of contact person
| 1st name | Takaaki |
| Middle name | |
| Last name | Hasegawa |
Organization
Nagoya City University Hospital
Division name
Center for Psycho-Oncology and Palliative Care
Zip code
467-8601
Address
Kawasumi 1, Mizuho-cho, Mizuho-ku, Nagoya
TEL
052-851-5511
Homepage URL
takaaki_hase@bird.ocn.ne.jp
Sponsor or person
Institute
Nagoya City University Hospital
Institute
Department
Personal name
Funding Source
Organization
Japanese Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Research Management Center, Nagoya City University Hospital
Address
Kawasumi 1, Mizuho-cho, Mizuho-ku, Nagoya
Tel
052-851-5511
clinical_research@med.nagoya-cu.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
| 2025 | Year | 01 | Month | 06 | 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
| 2024 | Year | 11 | Month | 12 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 09 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 06 | Day |
Last follow-up date
| 2031 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 12 | Month | 26 | Day |
Last modified on
| 2024 | Year | 12 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064658
