UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058637 |
|---|---|
| Receipt number | R000066892 |
| Scientific Title | Patient-reported outcome measures for patients with gynecologic cancer-related lower extremity lymphedema: a scoping review |
| Date of disclosure of the study information | 2025/07/29 |
| Last modified on | 2025/07/29 18:29:47 |
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Basic information
Public title
Patient-reported outcome measures for patients with gynecologic cancer-related lymphedema: a scoping review
Acronym
Patient-reported outcome measures for patients with gynecologic cancer-related lymphedema: a scoping review
Scientific Title
Patient-reported outcome measures for patients with gynecologic cancer-related lower extremity lymphedema: a scoping review
Scientific Title:Acronym
Patient-reported outcome measures for patients with gynecologic cancer-related lymphedema: a scoping review
Region
| Japan |
Condition
Condition
Lymphedema
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To review lymphedema-specific patient-reported outcome (PROM) scales used to evaluate patients with gynecologic cancer-related lower limb lymphedema, and to clarify existing scales that can evaluate self-regulation of lymphedema self-care.
Basic objectives2
Others
Basic objectives -Others
To review lymphedema-specific patient-reported outcome (PROM) scales used to evaluate patients with gynecologic cancer-related lower limb lymphedema, and to clarify existing scales that can evaluate self-regulation of lymphedema self-care.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The self-regulation component is included in existing scales
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1.Airticles on the development of a PROM scale specific to lower limb lymphedema
2.Measures that can be used by gynecologic cancer patients
3.Airticles written in Japanese or English
Key exclusion criteria
1.A translated version of the original scale
2.An initial version of the scale for which a shortened or revised version has been developed
3.Only for filariasis, primary lymphedema, and men
4.A scale intended for lymphedema screening
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Junko |
| Middle name | |
| Last name | Takagai |
Organization
Akita University Graduate School of Medicine
Division name
Department of Health Sciences
Zip code
010-8543
Address
1-1-1 Hondo, Akita City, Akita Prefecture
TEL
018-884-6545
jtakagai@hs.akita-u.ac.jp
Public contact
Name of contact person
| 1st name | Junko |
| Middle name | |
| Last name | Takagai |
Organization
Akita University Graduate School of Medicine
Division name
Department of Health Sciences
Zip code
0108543
Address
1-1-1 Hondo, Akita City, Akita Prefecture
TEL
018-884-6545
Homepage URL
jtakagai@hs.akita-u.ac.jp
Sponsor or person
Institute
Akita University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Akita University Graduate School of Medicine
Address
1-1-1 Hondo, Akita City, Akita Prefecture
Tel
0188846545
jtakagai@hs.akita-u.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
秋田
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 07 | Month | 29 | 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
| 2025 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
In order to extract literature on the development of lymphedema-specific PROM scales that include patients with lower limb lymphedema due to gynecological cancer, English articles will be searched in PubMed, Google Scholar, CINAHL Full Text, SCOPUS, and Web of Science, while Japanese articles will be searched in Igaku Chuo Zasshi.
The search format for English articles will be "Lymphoedema OR Lymphedema", "scale OR index OR inventory OR assessment OR questionnaire OR tool OR measure", "reliability OR validity OR development", with title searches for Google Scholar and title or abstract searches for other articles. For Igaku Chuo Zasshi, articles with abstracts and full text available will be searched for lymphedema, reliability, validity, and development. Eligible studies will be articles written in English or Japanese that develop lower limb lymphedema-specific PROM scales that include patients with gynecological cancer.
The exclusion criteria were: 1) translated versions of the original scale; 2) early versions of scales for which a shortened or revised version has been developed; 3) filarial lymphedema, primary lymphedema, or scales targeting only men; and 4) scales intended for lymphedema screening. All duplicate articles were excluded, and based on the set criteria, two researchers independently checked the titles and abstracts, read the full text, and excluded literature that did not meet the criteria. After reviewing the extracted scales, similar items were combined for each scale to extract items related to self-regulation in accordance with Bandura's self-regulation theory.
Management information
Registered date
| 2025 | Year | 07 | Month | 29 | Day |
Last modified on
| 2025 | Year | 07 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066892
