UMIN-CTR Clinical Trial

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
Email	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
Email	arai@chs.pref.kagawa.jp

Sponsor
Institute	Kagawa Prefectural University Of Health Sciences Department of Nursing, Faculty of Health Sciences
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055206