UMIN-CTR Clinical Trial

Basic information
Public title	Research on effect of an Oral Mucositis self-management nursing care program for head and neck cancer patients receiving radiotherapy.
Acronym	Effect of an Oral Mucositis self-management nursing care program for head and neck cancer patients receiving radiotherapy.
Scientific Title	Research on effect of an Oral Mucositis self-management nursing care program for head and neck cancer patients receiving radiotherapy.
Scientific Title:Acronym	Effect of an Oral Mucositis self-management nursing care program for head and neck cancer patients receiving radiotherapy.
Region	Japan

Condition
Condition	Head and neck cancer
Classification by specialty	Oto-rhino-laryngology Nursing
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is assess the effects of a nursing care program to promote the self-management for oral mucositis of head and neck cancer patients receiving radiotherapy.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Grade of oral mucositis
Key secondary outcomes	Oral mucositis related symptoms severity QOL Self-efficacy Psychological distress

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Intervention groups receive twice session of the self- management promote program delivery by trained nurses during radiotherapy.
Interventions/Control_2	Control groups will receive usual care.
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	50 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	They (1) diagnosed with squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx, (2) older than 50 years, (3) receiving treatment with radiotherapy with curative intent, (4) able to read and write Japanese,(5) decide and write the consent of participation to this study.
Key exclusion criteria	They (1) have adverse events greater than G 3 at the time of research request, (2) have diabetes or brain tumor, dialysis, speech disorder after glossectomy.
Target sample size	30

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Fusako DOI
Organization	Chiba University
Division name	Graduate school of Nursing
Zip code
Address	1-8-1 Inohana,chuo-ku,Chiba 260-8672 Japan
TEL	043-222-7171
Email	fusaco.n@chiba-u.jp

Public contact
1st name of contact person	1st name Middle name Last name Fusako DOI
Organization	Chiba University
Division name	Graduate school of Nursing
Zip code
Address	1-8-1 Inohana,chuo-ku,Chiba 260-8672 Japan
TEL	043-222-7171
Homepage URL
Email	fusaco.n@chiba-u.jp

Sponsor
Institute	Chiba University
Institute
Department

Funding Source
Organization	No
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
Address
Tel
Email

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	2018 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	Completed
Date of protocol fixation	2018 Year 04 Month 09 Day
Date of IRB	2018 Year 05 Month 18 Day
Anticipated trial start date	2018 Year 06 Month 01 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 05 Month 17 Day
Last modified on	2019 Year 04 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037208