UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038334 |
|---|---|
| Receipt number | R000043689 |
| Scientific Title | Verification of the effect of Telenursing system for cancer pain relief in patients with advanced cancer |
| Date of disclosure of the study information | 2019/11/01 |
| Last modified on | 2020/04/20 14:46:12 |
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Basic information
Public title
Verification of the Effect of Telenursing System for Cancer Pain Relief in Cancer Patients
Acronym
Verification of Telenursing System for Cancer Pain Relief
Scientific Title
Verification of the effect of Telenursing system for cancer pain relief in patients with advanced cancer
Scientific Title:Acronym
Verification of the Effect of Telenursing System for Cancer Pain Relief
Region
| Japan |
Condition
Condition
Patients with advanced cancer
Classification by specialty
| Nursing |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
A randomized controlled trial is performed to verify the effectiveness of a telenursing system for cancer pain relief in patients with advanced cancer in opioid medication. We evaluate the interface by the mixed method to the subject using the telenursing system.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Japanese Brief Pain Inventory
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Intervention of a telenursing system for cancer pain relief for one month.
Interventions/Control_2
Receive care using pain diary for one month.
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)Advanced cancer
2)Opioids are regularly taken for cancer pain relief purposes
3)Pain average NRS3 or more in 24 hours
4)Prognosis of more than one month is expected
5)Must be 20 years of age or older
6)Have received a notification of the name of the disease
7)Consent can be obtained for this study
Key exclusion criteria
1)Not advanced cancer
2)Opioids are regularly taken for the purpose of relieving cancer pain such as dyspnea
3)Pain average NRS3 in 24 hours<
4)Prognosis within one month
5)Under 20 years old
6)Not receiving notification of the name of the disease
7)Physical, mental, and cognitive problems with participation in research
Target sample size
48
Research contact person
Name of lead principal investigator
| 1st name | Fumiko |
| Middle name | |
| Last name | Sato |
Organization
Tohoku University
Division name
Department of Oncology Nursing
Zip code
980-8575
Address
2-1 Seiryo-cho, Aoba-ku, Sendai, Miyagi Prefecture
TEL
022-717-7926
fsato@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Shiori |
| Middle name | |
| Last name | Yoshida |
Organization
Tohoku University
Division name
Department of Oncology Nursing
Zip code
980-8575
Address
2-1 Seiryo-cho, Aoba-ku, Sendai, Miyagi Prefecture
TEL
022-717-7926
Homepage URL
shiori.y@med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee, Graduate School of Medicine, Tohoku University
Address
2-1 Seiryo-cho, Aoba-ku, Sendai, Miyagi Prefecture
Tel
022-728-4105
med-kenkyo@grp.tohoku.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 | 11 | 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
Open public recruiting
Date of protocol fixation
| 2019 | Year | 10 | Month | 28 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 28 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 12 | 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 | 10 | Month | 18 | Day |
Last modified on
| 2020 | Year | 04 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043689
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
