UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055365 |
|---|---|
| Receipt number | R000063274 |
| Scientific Title | Exploratory Study on Supportive Care for Gynecologic Cancer Patients |
| Date of disclosure of the study information | 2025/02/01 |
| Last modified on | 2024/08/29 17:41:25 |
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Basic information
Public title
Exploratory Study on Supportive Care for Gynecologic Cancer Patients
Acronym
Exploratory Study on Supportive Care for Gynecologic Cancer Patients
Scientific Title
Exploratory Study on Supportive Care for Gynecologic Cancer Patients
Scientific Title:Acronym
Exploratory Study on Supportive Care for Gynecologic Cancer Patients
Region
| Japan |
Condition
Condition
Gynecological Cancer
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To establish feasible supportive care that meets the needs of gynecological cancer patients.
Basic objectives2
Others
Basic objectives -Others
We will establish a cancer supportive care clinic within our gynecology department and conduct an exploratory examination of the best follow-up intervals and duration, types and methods of symptom screening, supportive care methods, and the frequency and methods of text-based bidirectional communication, in conjunction with patient satisfaction.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
The optimal timing for visiting a gynecological cancer supportive care clinic
Key secondary outcomes
1) Identification of unmet needs on gynecological cancer supportive care
2) Changes in quality of life (QOL) during visits to gynecological cancer supportive care clinics
3) Qualitative study on patient attitudes in gynecological cancer supportive care clinics
4) Identification of unmet needs in bidirectional communication via text messages
5) Changes in quality of life (QOL) during bidirectional communication via text messages
6) Qualitative study on patient attitudes in bidirectional communication via text messages
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Visiting a gynecological cancer supportive care clinic
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
| 18 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Female
Key inclusion criteria
1) Diagnosed with gynecologic cancer at Kyoto University Hospital.
2) Includes all stages.
3) Regardless of whether it is the initial or recurrent cancer.
4) Female patients aged 18 years or older at the time of consent/accrual.
Key exclusion criteria
1) Patients who lack sufficient decision-making capacity, are unconscious, or require special consideration regarding their diagnosis.
2) Metastatic cancer.
3) Patients whom the principal investigator deems inappropriate for inclusion in the study.
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | Ken |
| Middle name | |
| Last name | Yamaguchi |
Organization
Kyoto University School of Medicine
Division name
Department of gynecology and obstetrics
Zip code
606-8507
Address
Kawaharacho 51, Shogoin, Sakyo-ku, Kyoto city
TEL
0757513269
nozomi28@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Nozomi |
| Middle name | |
| Last name | Higashiyama |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of gynecology and obstetrics
Zip code
606-8507
Address
Kawaharacho 51, Shogoin, Sakyo-ku, Kyoto city
TEL
0757513269
Homepage URL
nozomi28@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
DUMSCO Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
Yoshida-Konoe-cho, Sakyo-ku, Kyoto 606-8501, JAPAN
Tel
075-753-4680
ethcom@kuhp.kyoto-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
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 02 | Month | 01 | 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
| 2024 | Year | 08 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 12 | 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
| 2024 | Year | 08 | Month | 29 | Day |
Last modified on
| 2024 | Year | 08 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063274
