UMIN-CTR Clinical Trial

Basic information
Public title	Clinical Utility of a Nursing Intervention Program for Promoting Self-management of Cancer Pain in Outpatients
Acronym	Clinical Utility of a Nursing Intervention Program for Promoting Self-management of Cancer Pain in Outpatients
Scientific Title	Clinical Utility of a Nursing Intervention Program for Promoting Self-management of Cancer Pain in Outpatients
Scientific Title:Acronym	Clinical Utility of a Nursing Intervention Program for Promoting Self-management of Cancer Pain in Outpatients
Region	Japan

Condition
Condition	cancer pain
Classification by specialty	Nursing
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to evaluate of clinical utility of a nursing intervention program for promoting self-management of cancer pain in outpatients.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Pain intensity after : NRS 0-10 Evaluation time is before and after intervention.
Key secondary outcomes	1. Influence on daily life with a pain: Brief pain inventory (short form) Japanese version (BPI-J) 2. QOL: 12 item Sort-form health survey (SF-12) Japanese version 3. Performance Status: Performance Status (PS) 4. Self-efficacy: Pain Self-Efficacy Questionnaire Japanese version (PSEQ-J) 5. Effective use of analgesics: BPI-J, NRS 0-10, Pain management Index (PMI) 6. Anxiety and depression: Hospital anxiety and depression scale (HADS) Japanese version

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	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	Nurses conduct 3 times of individual sessions to an outpatient with cancer pain, and promoting self-management of cancer pain in outpatients.
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	Outpatients who meet criteria below ; outpatients aged 20 and over ; have a received diagnosis and a notice of cancer ; a patient's presumed life expectancy is six months or more ; have cancer pain which continues one week or more ; have cancer pain more than 3 (NRS 0-10) ; have opioid analgesics prescribed ; are 0-3 performance status (PS) ; can read and write Japanese ; are an intention which participates in the complete of a nursing intervention program ; can give informed consent.
Key exclusion criteria	Outpatients who meet criteria below ; are planning surgical medical treatment and a hospitalization within two months ; have only a pain by the side effects of a surgical operation, chemotherapy, and radiotherapy ; are having the psychiatric disorder diagnosed ; have remarkable cognitive dysfunction ; were hospitalized two weeks or more during the intervention.
Target sample size	15

Research contact person
Name of lead principal investigator	1st name Masako Middle name Last name Yamanaka
Organization	Tenri Health Care University
Division name	Department of Nursing Science, Faculty of Health Care
Zip code	632-0018
Address	80-1 Bessho-cho, Tenri, Nara, Japan
TEL	0743-63-7811
Email	m.yamanaka@tenriyorozu-u.ac.jp

Public contact
Name of contact person	1st name Masako Middle name Last name Yamanaka
Organization	Tenri Health Care University
Division name	Department of Nursing Science, Faculty of Health Care
Zip code	632-0018
Address	80-1 Bessho-cho, Tenri, Nara, Japan
TEL	0743-63-7811
Homepage URL
Email	m.yamanaka@tenriyorozu-u.ac.jp

Sponsor
Institute	Tenri Health Care University
Institute
Department

Funding Source
Organization	The Ministy of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Tenri Health Care University, & Research Ethics Committee
Address	80-1 Bessho-cho, Tenri, Nara, Japan
Tel	0743-63-7811
Email	komori.c@tenriyorozu-u.ac.jp

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	2019 Year 07 Month 04 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	15
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	2019 Year 06 Month 24 Day
Date of IRB	2019 Year 06 Month 26 Day
Anticipated trial start date	2019 Year 07 Month 22 Day
Last follow-up date	2020 Year 08 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	2019 Year 07 Month 04 Day
Last modified on	2021 Year 01 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042490