UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043980 |
|---|---|
| Receipt number | R000049722 |
| Scientific Title | The Frequency of functional somatic syndromes in patients diagnosed with cancer receiving palliative care. A Multi-Center, Observational Study. |
| Date of disclosure of the study information | 2021/06/01 |
| Last modified on | 2021/04/20 12:09:09 |
* 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
The Frequency of functional somatic syndromes in patients diagnosed with cancer receiving palliative care. A Multi-Center, Observational Study.
Acronym
Functional somatic syndrome in cancer patients
Scientific Title
The Frequency of functional somatic syndromes in patients diagnosed with cancer receiving palliative care. A Multi-Center, Observational Study.
Scientific Title:Acronym
Functional somatic syndrome in cancer patients
Region
| Japan |
Condition
Condition
Patients diagnosed with cancer
Classification by specialty
| Psychosomatic Internal Medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the frequency and clinical characteristics of functional somatic syndromes in patients diagnosed with cancer during palliative care intervention.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Frequency of functional somatic syndromes
Key secondary outcomes
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
| 12 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients during palliative care intervention
2) Patients diagnosed with cancer
Key exclusion criteria
Consciousness disorder, pain assessment is impossible
Target sample size
1200
Research contact person
Name of lead principal investigator
| 1st name | Hideaki |
| Middle name | |
| Last name | Hasuo |
Organization
Kansai Medical University
Division name
Department of Psychosomatic Medicine
Zip code
573-1010
Address
2-5-1-505, Shinmach, Hirakata, Osaka
TEL
072-804-0101
hasuohid@hirakata.kmu.ac.jp
Public contact
Name of contact person
| 1st name | Hideaki |
| Middle name | |
| Last name | Hasuo |
Organization
Kansai Medical University
Division name
Department of Psychosomatic Medicine
Zip code
573-1010
Address
2-5-1-505, Shinmach, Hirakata, Osaka
TEL
072-804-0101
Homepage URL
hasuohid@hirakata.kmu.ac.jp
Sponsor or person
Institute
Kansai Medical University
Institute
Department
Personal name
Funding Source
Organization
Kansai Medical University
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
Kansai Medical University
Address
2-5-1-505, Shinmach, Hirakata, Osaka
Tel
072-804-0101
hasuohid@hirakata.kmu.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
関西医科大学附属病院（大阪府）、神戸赤十字病院（兵庫県）、和歌山赤十字病院（和歌山県）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 06 | 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
| 2021 | Year | 04 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2021 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Cross-sectional study
Management information
Registered date
| 2021 | Year | 04 | Month | 20 | Day |
Last modified on
| 2021 | Year | 04 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049722
