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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000043865
Receipt No. 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 2021/04/08

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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
Obsterics 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 168

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
Email 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
Email kiriko916@keio.jp

Sponsor
Institute Department of Rehabilitaion medicine, Keio University School of Medicine
Institute
Department

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
Email 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
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
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
2026 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
2021 Year 04 Month 08 Day


Link to view the page
URL(English) https://upload.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


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