UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047075 |
|---|---|
| Receipt number | R000053700 |
| Scientific Title | Evaluation of the Effect of Remote Assistance by A Nurse To Preoperative Respiratory Rehabilitation in Video-assisted Thoracic Surgery Lobectomy or Segmentectomy: A randomized controlled trial |
| Date of disclosure of the study information | 2022/03/04 |
| Last modified on | 2023/03/06 16:55:04 |
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Basic information
Public title
Evaluation of the Effect of Remote Assistance by A Nurse To Preoperative Respiratory Rehabilitation in Video-assisted Thoracic Surgery Lobectomy or Segmentectomy: A randomized controlled trial
Acronym
Evaluation of the Effect of Remote Assistance by A Nurse To Preoperative Respiratory Rehabilitation in Video-assisted Thoracic Surgery Lobectomy or Segmentectomy: A randomized controlled trial
Scientific Title
Evaluation of the Effect of Remote Assistance by A Nurse To Preoperative Respiratory Rehabilitation in Video-assisted Thoracic Surgery Lobectomy or Segmentectomy: A randomized controlled trial
Scientific Title:Acronym
Evaluation of the Effect of Remote Assistance by A Nurse To Preoperative Respiratory Rehabilitation in Video-assisted Thoracic Surgery Lobectomy or Segmentectomy: A randomized controlled trial
Region
| Japan |
Condition
Condition
malignant lung tumor
Classification by specialty
| Nursing |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
An open-label randomized controlled trial will determine whether nurses' remote assistance with preoperative respiratory rehabilitation, which patients perform at home, improves postoperative hospital stay for patients undergoing thoracoscopic lobectomy and segmentectomy for malignant tumors.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Number of postoperative days in the hospital
Key secondary outcomes
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
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
For breathing training at home during the hospitalization waiting period
Intervention group: performed with remote assistance from nurses / Control group: performed by themselves without nurse assistance
Interventions/Control_2
Number of interventions
Intervention group: 2 to 3 times until hospitalization (days 2, 5, and 8 after instruction) / Control group: 0 times
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
(1) Patients with malignant tumors who meet the indication criteria of the critical path for thoracoscopic lobectomy
Criteria for indication for thoracoscopic lobectomy path at cooperating institutions: cases in which specoscopic lobectomy and sectional resection are performed.
(2) Those who have a smart phone, computer or phone
(3) Patients who can perform preoperative respiratory rehabilitation by themselves at home.
(4) Those who have been fully informed and have given their free and voluntary written consent to participate in this study.
Key exclusion criteria
(1) Patients with malignant tumors undergoing procedures other than thoracoscopic lobectomy and segmentectomy
(2) Those whose attending physician predicts that the patient will not progress according to the thoracoscopic lobectomy critical path after the operation based on the patient's condition.
(3) Patients who have physical or mental difficulties in performing preoperative respiratory rehabilitation.
(4) Those who cannot give consent to participate in this study.
(5) Persons who are judged by the attending physician, principal investigator, or principal study authorization holder to be inappropriate to participate in this study.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Noriko |
| Middle name | |
| Last name | Nishikido |
Organization
Tokai University School of Medicine
Division name
Nursing
Zip code
259-1193
Address
143 Shimokasuya, Isehara-shi, Kanagawa
TEL
0463-93-1121
noriko-n@tokai-u.jp
Public contact
Name of contact person
| 1st name | Yasuko |
| Middle name | |
| Last name | Muraki |
Organization
Tokai University Graduate School
Division name
Medicine Course
Zip code
259-1193
Address
143 Shimokasuya, Isehara-shi, Kanagawa
TEL
0463-93-1121
Homepage URL
0cmud013@cc.u-tokai.ac.jp
Sponsor or person
Institute
NTT Medical Center Tokyo
Institute
Department
Personal name
Funding Source
Organization
Tokai University Graduate School Medicine Course
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
Institution Review Board for Clinical Research, Tokai University
Address
143 Shimokasuya, Isehara-shi, Kanagawa
Tel
0463-93-1121
tokai-rinsho@ml.tokai-u.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
21-124
Org. issuing International ID_1
Ethics and Medical Audit Committee, NTT Medical Center Tokyo
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
NTT東日本 関東病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 03 | Month | 04 | 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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 01 | Month | 15 | Day |
Date of IRB
| 2022 | Year | 01 | Month | 28 | Day |
Anticipated trial start date
| 2022 | Year | 03 | Month | 05 | Day |
Last follow-up date
| 2023 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 03 | Month | 04 | Day |
Last modified on
| 2023 | Year | 03 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000053700
