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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016948
Receipt No. R000019674
Scientific Title Examine the patient's response and symptom improvement using the Integrated Approach to Symptom Management Model for the patients who has oral mucositis associated with hematologic cancer therapy
Date of disclosure of the study information 2015/04/01
Last modified on 2017/03/21

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Basic information
Public title Examine the patient's response and symptom improvement using the Integrated Approach to Symptom Management Model for the patients who has oral mucositis associated with hematologic cancer therapy
Acronym The effect of Integrated Approach to Symptom Management for oral mucositis under hematologic cancer therapy
Scientific Title Examine the patient's response and symptom improvement using the Integrated Approach to Symptom Management Model for the patients who has oral mucositis associated with hematologic cancer therapy
Scientific Title:Acronym The effect of Integrated Approach to Symptom Management for oral mucositis under hematologic cancer therapy
Region
Japan

Condition
Condition hematological malignancies
oral mucositis associated with cancer therapy
Classification by specialty
Nursing
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To examine the effect of the Integrated Approach to Symptom Management (IASM) for the patients who has oral mucositis associated with hematologic cancer therapy. The guide book ver.9 for nurse's activity will be used.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes condition of oral hygiene include oral mucositis, mouth moist
Key secondary outcomes self-efficacy scale for cancer patients
SF-36v2
self-care ability (scale)

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 Period: to March 31st 2016
Frequency : 4 times
First Intervention:
1)Interview according to guide book. Conduct observation of oral condition.
2)Understand the symptom experience of the patient and feedback it empathically.
3)Assessment of self-care ability.
4)Share the plan of the preventive intervention.
5)Provide essential knowledge, essential skill, essential nursing support. (use the original pamphlet)
6)Measure the outcome scales.
7)Patients will record their symptom and care for themselves.

Second and Third Intervention:
1)Listen and understand patient's symptom experience.
2)Positive feedback.
3)Practice the above 3)4)5)6).

Final Intervention:
1)Review and share the process for 4 weeks.
2)Recognize and identify patient's effort and make sure their achievement.
3)Measure the outcome scales.
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 1)Patients undergoing hematologic cancer therapy
2)Patients who have the ability to communicate in Japanese and respond to the questionnaire without any cognitive disability.
Key exclusion criteria 1)Patients undergoing myeloablative regimens for hematopoietic stem cell transplantation.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Atsuko Uchinuno
Organization University of Hyogo
Division name College of Nursing
Zip code
Address 13-71 Kitaouji-cho,Akashi,Hyogo,673-8588 JAPAN
TEL 078-925-9435
Email a_uchinuno@cnas.u-hyogo.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroe Nakano
Organization University of Hyogo
Division name College of Nursing
Zip code
Address 13-71 Kitaouji-cho,Akashi,Hyogo,673-8588 JAPAN
TEL 078-925-9434
Homepage URL http://sm-support.net/
Email hiroe_nakano@cnas.u-hyogo.ac.jp

Sponsor
Institute University of Hyogo
Institute
Department

Funding Source
Organization Japan Society for the promotion of Science
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

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 京都大学医学部附属病院(京都府)、熊本医療センター(熊本県)、熊本大学医学部附属病院(熊本県)、浜の町病院(福岡県)

Other administrative information
Date of disclosure of the study information
2015 Year 04 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
2015 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 03 Month 27 Day
Last modified on
2017 Year 03 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019674

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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