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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000037880
Receipt No. R000043179
Scientific Title Posttraumatic growth after the surgery
Date of disclosure of the study information 2019/11/01
Last modified on 2019/09/03

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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
Classification by specialty
Chest surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To analyze post-traumatic growth after the lung surgery
Basic objectives2 Others
Basic objectives -Others Post-traumatic growth 1month after the lung 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 lung surgery in Kyoto Prefectural University of Medicine Hospital
Patient with written informed consent
Key exclusion criteria Metastatic lung tumor
Lung cancer with metastasis to other organ.
History of lung 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
Email 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
Email rhorie@koto.kpu-m.ac.jp

Sponsor
Institute Kyoto Prefectural University of Medicine
Institute
Department

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
Email 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 Preinitiation
Date of protocol fixation
2019 Year 09 Month 01 Day
Date of IRB
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
2019 Year 09 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043179

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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