UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014469 |
|---|---|
| Receipt number | R000016836 |
| Scientific Title | Examine the patient's response and symptom improvement using the intervention under the Integrated Approach to Symptom Management Model for the patients who has lymphedema |
| Date of disclosure of the study information | 2014/07/14 |
| Last modified on | 2017/03/31 10:56:20 |
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Basic information
Public title
Examine the patient's response and symptom improvement using the intervention under the Integrated Approach to Symptom Management Model for the patients who has lymphedema
Acronym
Effect of Integrated Approach to Symptom Management for lymphedema associated with cancer therapy (surgery/ radiation)
Scientific Title
Examine the patient's response and symptom improvement using the intervention under the Integrated Approach to Symptom Management Model for the patients who has lymphedema
Scientific Title:Acronym
Effect of Integrated Approach to Symptom Management for lymphedema associated with cancer therapy (surgery/ radiation)
Region
| Japan |
Condition
Condition
lymphedema associated with cancer therapy
Classification by specialty
| Nursing |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of Integrated Approach to Symptom Management (IASM) for the patients who has lymphedema (hand or leg). 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
limb circumference
Hand20/ SF-36v2 Japanese
Key secondary outcomes
self-efficacy scale for cancer patients
Skindex29
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 | Maneuver |
Interventions/Control_1
Period: from July 16th 2014 to March 31st 2016
Frequency: 4 times
First Intervention:
1) Interview according to guidebook.
2) Understanding the symptom experience of the patient.
3) Assessment of self-care ability.
4) Share the plan of the intervention.
5) Provide essential knowledge, essential skill, essential nursing support.
6) Patients record their symptom and practice they have done.
Second and Third Intervention:
1) Listen and understand patient's experience.
2) Practice 3)4)5) of First Intervention.
Final Intervention:
1) Summarize whole practice.
2) Share the emotional feeling.
3) Recognize patient's effort and practice they have done.
4) 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) Out patients who have lymphedema associated with surgery or radiation therapy.
2) At least 1 month has progressed after the radiation therapy or at least 3 months has progressed after the surgery.
3) Age: over 20 years old.
4) Having the ability to communicate in Japanese and to response to the questionnaire without any cognitive disability.
Key exclusion criteria
1) Less than 3 months after the surgery or less than 1 month after the radiation therapy.
2) Patients who has contraindication of lymphedema drainage therapy.
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 | Masamichi Fukuda |
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
masamichi_fukuda@cnas.u-hyogo.ac.jp
Sponsor or person
Institute
University of Hyogo
Institute
Department
Personal name
Funding Source
Organization
Japans Society for the promotion of Science
Organization
Division
Category of Funding Organization
Other
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
京都府立医科大学附属病院（京都府）、京都大学医学部附属病院（京都）、大津市民病院（滋賀県）、兵庫県立がんセンター（兵庫県）、松江市立病院（島根県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 07 | Month | 14 | 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
Enrolling by invitation
Date of protocol fixation
| 2014 | Year | 07 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 12 | 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
| 2014 | Year | 07 | Month | 03 | Day |
Last modified on
| 2017 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016836
