UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043865 |
|---|---|
| Receipt number | R000050068 |
| Scientific Title | Evaluation of health-related quality of life and physical activity in patients undergoing radical endometrial cancer |
| Date of disclosure of the study information | 2021/04/08 |
| Last modified on | 2024/04/10 12:35:50 |
* 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
Evaluation of health-related quality of life and physical activity in patients undergoing radical endometrial cancer
Acronym
Evaluation of health-related quality of life in patients undergoing radical endometrial cancer
Scientific Title
Evaluation of health-related quality of life and physical activity in patients undergoing radical endometrial cancer
Scientific Title:Acronym
Evaluation of health-related quality of life in patients undergoing radical endometrial cancer
Region
| Japan |
Condition
Condition
cancer
Classification by specialty
| Obstetrics and Gynecology | Rehabilitation medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose is to explore changes in health-related quality of life over time from postoperative to 12 months after surgery for endometrial cancer patients, and to clarify factors related to health-related quality of life.
Basic objectives2
Others
Basic objectives -Others
To conduct a questionnaire survey using a self-administered questionnaire on health-related quality of life and amount of activity in daily life of endometrial cancer patients from postoperative to 12 months postoperative, and to explore changes over time. To clarify the relationship between health-related quality of life and the amount of physical activity.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation period: Postoperative, 6 months postoperative, 12 months postoperative
Outcome: Health-related quality of life scale (The European Organization for Research and Treatment of Cancer QLQ-C30)
Key secondary outcomes
Evaluation period:
Postoperative, 6 monts postoperative, 12months postoperative
Outcomes:
1 Health-related quality of life for endometria cancer (The European Organaization for Research and Treatment of Cancer QOL EN24)
2 Ovarian deficiency symptom scale ( The Keio Questionnaire)
3 Physical activity scale (International standardized physical activity questionnaire)
Base
Study type
Observational
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1 Cases pathologically diagnosed with endometrial cancer
2 From the date of approval by the Ethics Committees, patients who underwent surgery including total hysterectomy + bilateral adnexectomy as the initial treatment for endometrial cancer at keio University Hospital Gynecology
3 Cases over 20 years old
4 Cases that can be explained and understood in writing and signed with consent
5 Symptoms that are expected to be able to read the mailed questionnaire, create an answer, and reply.
Key exclusion criteria
1 Cases with active double cancer
2 Cases with a history of cancer within 5 years other than carcinoma in situ
3 Cases with a history of serious mental illness or complications
4 Cases in whch walking is not independent
5 Cases that require assistance in daily life
Target sample size
110
Research contact person
Name of lead principal investigator
| 1st name | Aiko |
| Middle name | |
| Last name | Ishikawa |
Organization
Keio University school of medicine
Division name
Rehabilitation medicine
Zip code
160-0016
Address
35 Shinanomachi Shinjyuku-ku, Tokyo
TEL
03-5363-3833
aishi@keio.jp
Public contact
Name of contact person
| 1st name | Kiriko |
| Middle name | |
| Last name | Abe |
Organization
Keio University school of medicine
Division name
Rehabilitation medicine
Zip code
160-0016
Address
35 Shinanomachi Shinjyuku-ku, Tokyo
TEL
03-5363-3833
Homepage URL
kiriko916@keio.jp
Sponsor or person
Institute
Department of Rehabilitaion medicine, Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University Facultory of Medicine Ethics Committee
Address
35 Shinanomachi Shinjyuku-ku, Tokyo
Tel
03-3353-1211
med-rinri-jimu@adst.keio.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
慶應義塾大学病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 04 | Month | 08 | 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
57
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
| 2021 | Year | 02 | Month | 26 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 30 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 08 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective observational study. Patients who have been diagnosed with endometrial cancer, admitted to a research cooperation facility, and underwent radical surgery are included. Extract patient information (age, gender, medical history, treatment course, imaging test, etc.) from medical records. In addition, a self-administered questionnaire survey related to health-related QOL, ovarian deficiency symptoms, and physical activity will be conducted for the study subjects at three time points: after radical cure, 6 months and 12 months after surgery.
Management information
Registered date
| 2021 | Year | 04 | Month | 08 | Day |
Last modified on
| 2024 | Year | 04 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050068
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
