UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028812
Receipt number R000032942
Scientific Title Evaluation the oral health behavior of head and neck cancer by psychological scale.
Date of disclosure of the study information 2017/09/01
Last modified on 2020/03/03 12:48:12

* 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

Evaluation the oral health behavior of head and neck cancer by psychological scale.

Acronym

Evaluation the oral health behavior of head and neck cancer

Scientific Title

Evaluation the oral health behavior of head and neck cancer by psychological scale.

Scientific Title:Acronym

Evaluation the oral health behavior of head and neck cancer

Region

Japan


Condition

Condition

head and neck cancer

Classification by specialty

Oral surgery Dental medicine

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

In the perioperative period in the treatment of head and neck cancer, morphological and functional changes in the oral cavity occur, resulting in deterioration of the oral hygiene environment. Therefore, attention was focused on the relationship between changes in oral hygiene due to professional oral care and psychological aspects of patients. We clarify whether improvement of oral hygiene can be expected by approaching psychologically from patients with head and neck cancer who are difficult to evaluate by tooth surface staining with an indicator of oral hygiene status so far.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Inprovement of oral health status

Key secondary outcomes

Change in scale score


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

Behavior,custom

Interventions/Control_1

We ask the questionnaire by psychological scale. This is done at the time of treatment decision, immediately before treatment, during treatment, at the end of treatment, after 3 to 6 months of treatment completion. Three question slips are used this time.

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

90 years-old >

Gender

Male and Female

Key inclusion criteria

Age: 20 years old and under 90
Gender: No prejudice
Hospitalization / outpatient: no question

Key exclusion criteria

Patient who is difficult to visit Nagasaki University Hospital Perioperative Oral Administration Center after treatment.
0 teeth without edentulous residual teeth.

Target sample size

10


Research contact person

Name of lead principal investigator

1st name Sakiko
Middle name
Last name Soutome

Organization

Nagasaki University Hospital

Division name

Perioperative Oral Management Center

Zip code

852-8588

Address

Nagasaki

TEL

095-819-7698

Email

sakiko@nagasaki-u.ac.jp


Public contact

Name of contact person

1st name Sakiko
Middle name
Last name Soutome

Organization

Nagasaki University Hospital

Division name

Perioperative Oral Management Center

Zip code

852-8588

Address

1-7-1 Sakamoto

TEL

095-819-7698

Homepage URL


Email

sakiko@nagasaki-u.ac.jp


Sponsor or person

Institute

Nagasaki University Hospital

Institute

Department

Personal name



Funding Source

Organization

Nagasaki University Hospital

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Nagasaki University Hospital

Address

1-7-1Sakamoto Nagasaki

Tel

095-819-7698

Email

gaibushikin@ml.nagasaki-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

2017 Year 09 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

10

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

Completed

Date of protocol fixation

2017 Year 09 Month 01 Day

Date of IRB

2017 Year 08 Month 22 Day

Anticipated trial start date

2017 Year 09 Month 10 Day

Last follow-up date

2019 Year 12 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2017 Year 08 Month 24 Day

Last modified on

2020 Year 03 Month 03 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032942


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name