UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048448 |
|---|---|
| Receipt number | R000055206 |
| Scientific Title | Development and Evaluation of a Self-Care Reacquisition Education Program for Patients with Lymphedema Stage II or Higher Following Gynecologic Cancer Treatment |
| Date of disclosure of the study information | 2022/07/25 |
| Last modified on | 2022/07/25 09:42:08 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Development and Evaluation of a Self-Care Reacquisition Education Program for Patients with Lymphedema Stage II or Higher Following Gynecologic Cancer Treatment
Acronym
Evaluation of a Self-Care Reacquisition Education Program for Lymphedema Patients
Scientific Title
Development and Evaluation of a Self-Care Reacquisition Education Program for Patients with Lymphedema Stage II or Higher Following Gynecologic Cancer Treatment
Scientific Title:Acronym
Evaluation of a Self-Care Reacquisition Education Program for Lymphedema Patients
Region
| Japan |
Condition
Condition
lymphedema
Classification by specialty
| Nursing |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To develop a self-care reacquisition educational program to be utilized for patients with lymphedema stage II or higher after gynecological cancer treatment, and to examine the effectiveness of this program.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
First time and 6 months afterLELI
Key secondary outcomes
LESMS scale
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
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
self-care education(+)
Interventions/Control_2
self-care education(-)
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
| 100 | years-old | >= |
Gender
Female
Key inclusion criteria
Lymphedema patients with stage II or higher lymphedema after treatment for gynecologic cancer
Key exclusion criteria
Patients with inflammatory diseases, pregnancy, and sedative disorders
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Etsuko |
| Middle name | |
| Last name | Arai |
Organization
Kagawa Prefectural University Of Health Sciences
Division name
Department of Nursing, Faculty of Health Sciences
Zip code
761-0123
Address
281-1 Murecho-hara, Takamatsu, Kagawa 761-0123 Japan
TEL
+81878701212
arai@chs.pref.kagawa.jp
Public contact
Name of contact person
| 1st name | Etsuko |
| Middle name | |
| Last name | Arai |
Organization
Kagawa Prefectural University Of Health Sciences
Division name
Department of Nursing, Faculty of Health Sciences
Zip code
761-0123
Address
281-1 Murecho-hara, Takamatsu, Kagawa 761-0123 Japan
TEL
+81878701212
Homepage URL
arai@chs.pref.kagawa.jp
Sponsor or person
Institute
Kagawa Prefectural University Of Health Sciences Department of Nursing, Faculty of Health Sciences
Institute
Department
Personal name
Funding Source
Organization
Kagawa Prefectural University Of Health Sciences Department of Nursing, Faculty of Health Sciences
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kagawa Prefectural University Of Health Sciences
Address
281-1 Murecho-hara, Takamatsu, Kagawa 761-0123 Japan
Tel
+81878701212
arai@chs.pref.kagawa.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
| 2022 | Year | 07 | Month | 25 | 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
20
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
No longer recruiting
Date of protocol fixation
| 2019 | Year | 08 | Month | 30 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 30 | Day |
Anticipated trial start date
| 2020 | Year | 05 | Month | 30 | Day |
Last follow-up date
| 2025 | Year | 03 | 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 | 07 | Month | 25 | Day |
Last modified on
| 2022 | Year | 07 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055206
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
