UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000038371
Receipt number R000043730
Scientific Title The frequency of Alexisomia and the effect in incurable cancer patients receiving palliative care. A multi-center, observational study.
Date of disclosure of the study information 2019/12/01
Last modified on 2023/04/27 08:24:44

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Basic information

Public title

The frequency of Alexisomia and the effect in incurable cancer patients receiving palliative care. A multi-center, observational study.

Acronym

Alexisomia in cancer patinets

Scientific Title

The frequency of Alexisomia and the effect in incurable cancer patients receiving palliative care. A multi-center, observational study.

Scientific Title:Acronym

Alexisomia in cancer patinets

Region

Japan


Condition

Condition

alexisomia

Classification by specialty

Psychosomatic Internal Medicine

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To investigate The frequency of Alexisomia and the effect in incurable cancer patients receiving palliative care.

Basic objectives2

Others

Basic objectives -Others

Related factors

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The frequency of Alexisomia

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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Incurable cancer patients

Key exclusion criteria

Uncontrolled psychiatric disease

Target sample size

240


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

5730011

Address

Shinmachi 2-5-1, 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

5730011

Address

Shinmachi 2-5-1, 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

Shinmachi 2-5-1, 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



Other administrative information

Date of disclosure of the study information

2019 Year 12 Month 01 Day


Related information

URL releasing protocol

https://pubmed.ncbi.nlm.nih.gov/34412497/

Publication of results

Published


Result

URL related to results and publications

https://pubmed.ncbi.nlm.nih.gov/34412497/

Number of participants that the trial has enrolled

262

Results

A total of 262 patients were selected as participants. Incurable cancer patients with alexisomia were observed in 30.2% of all participants [95% confidence interval (CI): 24.7-35.7]. The latent trigger points risk ratio in the alexisomic group versus the non-alexisomic group was 4.06 (95% CI: 2.24-7.37). Incurable cancer patients with alexisomia tended to have higher PNRS and PPG scores (P<0.001), but there was no significant difference in PPG achievement (P=0.641).

Results date posted

2023 Year 04 Month 27 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Patients with incurable cancer referred to a palliative care service at two university hospitals in Japan.

Participant flow

None

Adverse events

None

Outcome measures

Alexisomia was evaluated using the Shitsu-Taikan-Sho Scale (STSS). All patients were manually examined on their upper trapezius to identify latent trigger points. Patients who experienced pain reported their pain numerical rating scale (PNRS) and personalized pain goal (PPG) scores.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2019 Year 10 Month 01 Day

Date of IRB

2019 Year 12 Month 13 Day

Anticipated trial start date

2020 Year 01 Month 01 Day

Last follow-up date

2021 Year 06 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

1.The frequnecy of Alexisomia in incurable cancer patients reveiving palliative care.
2.Relationship between Alexisomia and pain intesity, personalized pain goal, and latent trigger points in the upper trapezius.


Management information

Registered date

2019 Year 10 Month 23 Day

Last modified on

2023 Year 04 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043730


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name