UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016948 |
|---|---|
| Receipt number | 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 21:09:21 |
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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
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/
hiroe_nakano@cnas.u-hyogo.ac.jp
Sponsor or person
Institute
University of Hyogo
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019674
