UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054339 |
|---|---|
| Receipt number | R000062077 |
| Scientific Title | Collaboration between Acute and Convalescent Hospitals in Prehabilitation to Improve the Outcome of Thoracic Surgery |
| Date of disclosure of the study information | 2024/05/08 |
| Last modified on | 2024/05/08 16:10:52 |
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Basic information
Public title
Collaboration between Acute and Convalescent Hospitals in Prehabilitation to Improve the Outcome of Thoracic Surgery
Acronym
Hospital Collaboration in for Thoracic Surgery
Scientific Title
Collaboration between Acute and Convalescent Hospitals in Prehabilitation to Improve the Outcome of Thoracic Surgery
Scientific Title:Acronym
Hospital Collaboration in for Thoracic Surgery
Region
| Japan |
Condition
Condition
lung cancer
Classification by specialty
| Chest surgery | Rehabilitation medicine | Nursing |
| Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to examine the impact on perioperative outcomes and quality of life in the perioperative period of lung cancer when a convalescent hospital and an acute care hospital collaborate in the perioperative management of respiratory surgery in a multidisciplinary and multiprofessional setting.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The primary endpoint is quality of life 1 year after surgery
Key secondary outcomes
The secondary outcomes are perioperative complication and long-term hospitalization rates. To assess the impact of the care model on predefined outcomes, data will be analyzed using descriptive and inferential statistics.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Rehabilitation and nutritional intervention for acute lung cancer surgery in a joint effort between a convalescent hospital and an acute care hospital
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
The eligible participants should be from the Lung Cancer and Respiratory Disease Centre and must meet the following criteria: a confirmed diagnosis requiring respiratory surgery and comprehensive preoperative risk assessment by the rehabilitation, nutrition, and nursing departments; specific conditions such as pulmonary decompensation and sarcopenia; need for postoperative home support; and provision of informed consent for study participation. The exclusion criteria included inability to participate in the rehabilitation program or lack of consent to participate.
Key exclusion criteria
The exclusion criteria included inability to participate in the rehabilitation program or lack of consent to participate.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Hirofumi |
| Middle name | |
| Last name | Uehara |
Organization
Hakodate Goryoukaku Hospital
Division name
Department of Thoracic Surgery,
Zip code
0408611
Address
38-3 Goryokaku-cho, Hakodate, Hokkaido Japan, 040-8611
TEL
0138512295
hirofumiuehara113@gmail.com
Public contact
Name of contact person
| 1st name | Hirofumi |
| Middle name | |
| Last name | Uehara |
Organization
Hakodate Goryoukaku Hospital
Division name
Department of Thoracic Surgery,
Zip code
0418611
Address
38-3 Goryokaku-cho, Hakodate, Hokkaido Japan, 040-8611
TEL
09097568570
Homepage URL
hirofumiuehara113@gmail.com
Sponsor or person
Institute
Hakodate Goryoukaku Hospital
Institute
Department
Personal name
Funding Source
Organization
Hakodate Goryoukaku Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hakodate Goryoukaku Hospital
Address
38-3 Goryokaku-cho, Hakodate, Hokkaido Japan
Tel
0138512295
hirofumiuehara113@gmail.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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 05 | Month | 08 | 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 | 01 | Month | 23 | Day |
Date of IRB
| 2024 | Year | 01 | Month | 23 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 23 | Day |
Last follow-up date
| 2027 | Year | 01 | Month | 23 | 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 | 05 | Month | 08 | Day |
Last modified on
| 2024 | Year | 05 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062077
