UMIN-CTR Clinical Trial

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
Institute	Nagasaki University Hospital
Institute
Department

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000032942