UMIN-CTR Clinical Trial

Basic information
Public title	Remote rehabilitation program for preoperative gastrointestinal cancer patient
Acronym	Remote rehabilitation program for preoperative gastrointestinal cancer patient
Scientific Title	Remote rehabilitation program for preoperative gastrointestinal cancer patient
Scientific Title:Acronym	Remote rehabilitation program for preoperative gastrointestinal cancer patient
Region	Japan

Condition
Condition	Gastrointestinal cancer
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Assessment of the feasibility of a novel remote rehabilitation program for preoperative gastrointestinal cancer patient
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase I,II

Assessment
Primary outcomes	Feasibility of a novel remote rehabilitation program for preoperative gastrointestinal cancer patient
Key secondary outcomes	Postoperative complications and prognosis

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 considered as a block.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Remote rehabilitation program
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	Not applicable
Gender	Male and Female
Key inclusion criteria	preoperative gastrointestinal cancer patient
Key exclusion criteria	1) Severe heart failure 2) COPD 3) Low PS 4) Renal failure 5) Liver failure 6) Dementia
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Tomoki Middle name Last name Yamatsuji
Organization	Kawasaki Medical School General Medical Center
Division name	Department of Surgery
Zip code	700-8505
Address	2-6-1 Nakasange, Okayama
TEL	0862252111
Email	yama-t@med.kawasaki-m.ac.jp

Public contact
Name of contact person	1st name Tomoki Middle name Last name Yamatsuji
Organization	Kawasaki Medical School General Medical Center
Division name	Department of Surgery
Zip code	700-8505
Address	2-6-1 Nakasange, Okayama
TEL	0862252111
Homepage URL
Email	yama-t@med.kawasaki-m.ac.jp

Sponsor
Institute	Department of General Surgery, Kawasaki Medical School General Medical Center
Institute
Department

Funding Source
Organization	Department of General Surgery, Kawasaki Medical School General Medical Center
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kawasaki Medical School
Address	577 Matsushima,Kurashiki-City,Okayama
Tel	0862252111
Email	yama-t@med.kawasaki-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	川崎医科大学総合医療センター

Other administrative information
Date of disclosure of the study information	2022 Year 02 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	2021 Year 01 Month 13 Day
Date of IRB
Anticipated trial start date	2022 Year 02 Month 01 Day
Last follow-up date	2024 Year 01 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 01 Month 14 Day
Last modified on	2022 Year 01 Month 14 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053198