UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037266 |
|---|---|
| Receipt number | R000042490 |
| Scientific Title | Clinical Utility of a Nursing Intervention Program for Promoting Self-management of Cancer Pain in Outpatients |
| Date of disclosure of the study information | 2019/07/04 |
| Last modified on | 2021/01/08 08:59:21 |
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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
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
m.yamanaka@tenriyorozu-u.ac.jp
Sponsor or person
Institute
Tenri Health Care University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042490
