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

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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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name