UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055794 |
|---|---|
| Receipt number | R000063730 |
| Scientific Title | Development of a rehabilitation nursing support program using tele-nursing systems for pancreatic cancer patients: A pilot study |
| Date of disclosure of the study information | 2024/10/10 |
| Last modified on | 2025/10/10 10:12:49 |
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Basic information
Public title
Development of the rehabilitation nursing support program using tele-nursing systems for pancreatic cancer patients: A pilot study
Acronym
Pancreatic cancer tele-nursing rehabilitation trial - pilot study -
Scientific Title
Development of a rehabilitation nursing support program using tele-nursing systems for pancreatic cancer patients: A pilot study
Scientific Title:Acronym
Pancreatic cancer tele-nursing rehabilitation trial - pilot study -
Region
| Japan |
Condition
Condition
pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery | Rehabilitation medicine |
| Nursing | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
In order to develop a rehabilitation nursing support program that combines a remote nursing system for pancreatic cancer patients, we will verify the validity of the content of the rehabilitation program combined with a remote nursing system and evaluate its feasibility for patients as a pilot study for the next RCT.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Patient adherence to the program 6 months after surgery
Key secondary outcomes
Validity (changes from baseline at 3 and 6 months in grip strength, knee extension strength, 6-minute walk, EORTC-C30, FACT-Hep, SDS, etc.) and safety (incidence of adverse events over the entire study period)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Daily exercises are carried out at home via video or self-directed training at least twice a week, and telenursing support is provided once every four weeks.
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Patients who have been clinically diagnosed with pancreatic cancer (including IPMC) and are planning to undergo surgery.
2. Patients undergoing initial treatment
3. Patients with a PS (ECOG classification) of 0 to 1
4. Patients with preserved function of major organs (bone marrow, liver, kidneys, lungs, etc.)
5. Patients who can take food orally
6. Patients who can use a tablet or smartphone and have a good internet connection at home
7. Patients who have given written consent to be subjects of this study
8. Adults aged 18 years or older at the time of consent acquisition who have sufficient judgment to give consent to this study
9. Patients who have received a sufficient explanation of the contents of this study and have given written consent
Key exclusion criteria
1. Patients with pulmonary fibrosis or interstitial pneumonia
2. Patients with macroscopic residual cancer at the time of resection
3. Patients with active overlapping cancers
4. Patients with active infections
5. Patients with positive HBs antigen
6. Patients using flucytosine, phenytoin, or warfarin
7. Patients who are pregnant or may be pregnant
8. Patients who are otherwise deemed unsuitable by the attending physician to safely conduct this study
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Naoko |
| Middle name | |
| Last name | Sato |
Organization
Fukushima Medical University
Division name
Faculty of Nursing
Zip code
960-1295
Address
1 Hikarigaoka, Fukushima City
TEL
0245471858
naoko-st@fmu.ac.jp
Public contact
Name of contact person
| 1st name | Naoko |
| Middle name | |
| Last name | Sato |
Organization
Fukushima Medical University
Division name
Faculty of Nursing
Zip code
960-1295
Address
1 Hikarigaoka, Fukushima City
TEL
0245471858
Homepage URL
naoko-st@fmu.ac.jp
Sponsor or person
Institute
Fukushima Medical University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science (JSPS)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fukushima Medical University General Ethics Committee
Address
1 Hikarigaoka, Fukushima City
Tel
0245471825
yukiki@fmu.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
| 2024 | Year | 10 | Month | 10 | 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
| 2024 | Year | 06 | Month | 10 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 10 | Day |
Anticipated trial start date
| 2025 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 10 | Month | 09 | Day |
Last modified on
| 2025 | Year | 10 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063730
