UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036985 |
|---|---|
| Receipt number | R000042135 |
| Scientific Title | Seamless Monitoring of Illness after Lung surgery for Enhanced support (SMILE-001 study) |
| Date of disclosure of the study information | 2019/06/06 |
| Last modified on | 2023/06/19 19:34:28 |
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Basic information
Public title
Seamless Monitoring of Illness after Lung surgery for Enhanced support (SMILE-001 study)
Acronym
SMILE-001 study
Scientific Title
Seamless Monitoring of Illness after Lung surgery for Enhanced support (SMILE-001 study)
Scientific Title:Acronym
SMILE-001 study
Region
| Japan |
Condition
Condition
Pulmonary malignancy (Lung cancer or metastatic lung tumor)
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
1) To describe the course of postoperative symptoms
Basic objectives2
Others
Basic objectives -Others
2) To describe patients' anxiety and the efficacy of discharge instruction on it
3) To specify the risk factor of unintentional re-admission after discharge by big-data analysis
4) To investigate usefulness of tablet hardware for self-management of patients undergoing lung cancer surgery
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Recovery rate of MDASI scores at the first outpatient visit after lung cancer surgery
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
To score patients' symptoms by MDASI using paper-based questionnaire
Interventions/Control_2
To score patients' symptoms by MDASI using tablet application- based questionnaire
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
The patients undergoing lung resection
between the date of KMU-REB approval and February 28th, 2021 who fulfill the inclusion criteria and deny the exclusion criteria as follows;
1) 20 years of age or older at the time of informed consent.
2) Pulmonary malignancy is diagnosed or suspected at the time of surgery
* The patient needs to express his/her consent to participate this study based on his/her own will by signed documentation.
Key exclusion criteria
The patients who shows either of following must be excluded;
1) Rejection to participate this study.
2) Decline of formely expressed consent to participate this study
3) Any inappropriate condition which necessitate research director to exclude the patient.
Target sample size
350
Research contact person
Name of lead principal investigator
| 1st name | Tomohito |
| Middle name | |
| Last name | SAITO |
Organization
Kansai Medical University Hospital
Division name
Department of Thoracic Surgery
Zip code
573-1191
Address
2-3-1 Shinmachi, Hirakata, Osaka 5731191, JAPAN
TEL
072-804-0101
saitotom@hirakata.kmu.ac.jp
Public contact
Name of contact person
| 1st name | Tomohito |
| Middle name | |
| Last name | SAITO |
Organization
Kansai Medical University Hospital
Division name
Department of Thoracic Surgery
Zip code
573-1191
Address
2-3-1 Shinmachi, Hirakata, Osaka 5731191, JAPAN
TEL
072-804-0101
Homepage URL
saitotom@hirakata.kmu.ac.jp
Sponsor or person
Institute
Department of Thoracic Surgery,
Kansai Medical University Hospital
Institute
Department
Personal name
Funding Source
Organization
1) Osaka Cancer Society
2) Department of Thoracic Surgery,
Kansai Medical University Hospital
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kansai Medical University Hospital Clinical Research Ethics Board
Address
2-3-1 Shinmachi, Hirakata, Osaka 5731191, JAPAN
Tel
072-804-0101
rinriirb@hirakata.kmu.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 | 06 | Month | 06 | Day |
Related information
URL releasing protocol
https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0281998
Publication of results
Published
Result
URL related to results and publications
https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0281998
Number of participants that the trial has enrolled
130
Results
Duration of symptom was the leading cause of postoperative distress. Several core symptoms after thoracoscopic lung resection showed a rebound in the trajectory. Specifically, a rebound in pain trajectory may be associated with unrecovered pain; pain severity on day 4 may predict early pain recovery. Further clarification of symptom severity trajectories is essential for patient-centered care.
Results date posted
| 2023 | Year | 06 | Month | 19 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
It took longer time for manuscript publication process than expected.
Date of the first journal publication of results
| 2023 | Year | 02 | Month | 22 | Day |
Baseline Characteristics
There were 75 patients. The median age was 70 years, and females accounted for 48%. The median interval from surgery to the first post-discharge clinic visit was 20 days.
Participant flow
Patients undergoing thoracoscopic lung resection for diagnosed or suspected pulmonary malignancy prospectively recorded daily symptom severity on a 0-10 scale based on MDASI.
Adverse events
None
Outcome measures
Symptom recovery
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2019 | Year | 03 | Month | 06 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 06 | Day |
Anticipated trial start date
| 2019 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2020 | Year | 10 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 11 | Month | 30 | Day |
Date analysis concluded
| 2022 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 06 | Month | 06 | Day |
Last modified on
| 2023 | Year | 06 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042135
