UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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
Title of the study (Brief title)	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	Atsuko Uchinuno
Organization	University of Hyogo
Division name	College of Nursing
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	Masamichi Fukuda
Organization	University of Hyogo
Division name	College of Nursing
Address	13-71 Kitaouji-cho,Akashi,Hyogo,673-8588 JAPAN
TEL	078-925-9434
Homepage URL
Email	masamichi_fukuda@cnas.u-hyogo.ac.jp

Sponsor
Institute	University of Hyogo
Institute
Department

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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2014 Year 07 Month 14 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000016836