UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037880 |
|---|---|
| Receipt number | R000043179 |
| Scientific Title | Posttraumatic growth after the surgery |
| Date of disclosure of the study information | 2019/11/01 |
| Last modified on | 2023/08/23 16:30:57 |
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Basic information
Public title
Posttraumatic growth after the surgery
Acronym
Posttraumatic growth after the surgery
Scientific Title
Posttraumatic growth after the surgery
Scientific Title:Acronym
Posttraumatic growth after the surgery
Region
| Japan |
Condition
Condition
lung cancer and mediastinum cancer
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To analyze post-traumatic growth after the malignant lung and mediastinum surgery
Basic objectives2
Others
Basic objectives -Others
Post-traumatic growth 1month after the malignant lung and mediastinum surgery and its association between preoperative psychological condition and postoperative pain will be analyzed.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Posttrauamtic growth one month after the surgery. Its association between surgical factors.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patient who receive malignant lung or mediastinum surgery in Kyoto Prefectural University of Medicine Hospital
Patient with written informed consent
Key exclusion criteria
History of chest surgery
History of psychiatric disease
Patient unable to answer to the questionary
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | amaya |
| Middle name | |
| Last name | fumimasa |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of pain management and palliative care medicine
Zip code
6020841
Address
Kajii-cho 465, Kamigyo-Ku, Kyoto
TEL
0752515177
ama@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Horie |
| Middle name | |
| Last name | Rina |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of pain management and palliative care medicine
Zip code
6020841
Address
Kajii-cho 465, Kamigyo-Ku, Kyoto
TEL
0752515177
Homepage URL
rhorie@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kyoto Prefectural University of Medicine
Japan Society for the Promotion of Science
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
Kyoto Prefectural University of Med
Address
Kajii-cho 465, Kamigyo-Ku, Kyoto
Tel
0752515177
rhorie@koto.kpu-m.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
| 2019 | Year | 11 | 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
| 2019 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 11 | Month | 19 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 01 | 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
Preoperative psychological condition, acute pain and PTG 1 months after the surgery will be analyzed.
Management information
Registered date
| 2019 | Year | 09 | Month | 01 | Day |
Last modified on
| 2023 | Year | 08 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043179
