UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050617 |
|---|---|
| Receipt number | R000057233 |
| Scientific Title | Controlled trial to evaluate the effectiveness of a tele-nursing system intervention for cancer pain relief in advanced cancer patients at home with crossover facilities |
| Date of disclosure of the study information | 2023/03/17 |
| Last modified on | 2023/03/17 13:05:48 |
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Basic information
Public title
Research on the Effectiveness of Nursing Care for Pain Relief of Cancer Patients under Home Care
Acronym
Research on the Effectiveness of Nursing Care for Pain Relief
Scientific Title
Controlled trial to evaluate the effectiveness of a tele-nursing system intervention for cancer pain relief in advanced cancer patients at home with crossover facilities
Scientific Title:Acronym
Controlled trial to evaluate the effectiveness of a tele-nursing system intervention for cancer pain relief in advanced cancer patients at home
Region
| Japan |
Condition
Condition
Advanced cancer patients under home care
Classification by specialty
| Hematology and clinical oncology | Nursing | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The main objective of this study is to verify the effectiveness of the tele-nursing system in palliating cancer pain in advanced cancer patients at home using the degree of cancer pain. In addition, we will evaluate the QOL of family members and other supporters who use the system together with the patients, and the effectiveness of the practice of home care nurses who were involved in tele-nursing during the study period.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
pain degree
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
telenursing
Interventions/Control_2
Control
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.Patient has advanced cancer in home care
2.Patient is using opioids
3.Patient has 24hour pain mean NRS of at least 3
4.Patient is over 20 years old
5.Patient has been informed of the name of the disease
Key exclusion criteria
1. Patient uses opioids for purposes other than to relieve cancer pain, such as dyspnoea
2. Patient has physical, mental or cognitive impairments
3. Patient is unable to read or write Japanese
Target sample size
96
Research contact person
Name of lead principal investigator
| 1st name | Shiori |
| Middle name | |
| Last name | Yoshida |
Organization
Tohoku University Graduate School
Division name
Oncology Nursing
Zip code
980-8575
Address
2-1 Seiryomachi, Aoba-ku, Sendai, Miyagi
TEL
+81-22-717-7926
shiori.y@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Shiori |
| Middle name | |
| Last name | Yoshida |
Organization
Tohoku University Graduate School
Division name
Oncology Nursing
Zip code
980-8575
Address
2-1 Seiryomachi, Aoba-ku, Sendai, Miyagi 980-8575, Japan
TEL
+81-22-717-7926
Homepage URL
shiori.y@med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
KAKENHI
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
Ethics Committee, Graduate School of Medicine, Tohoku University
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8575, Japan
Tel
022-717-8007
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
| 2023 | Year | 03 | Month | 17 | 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
Preinitiation
Date of protocol fixation
| 2022 | Year | 12 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2027 | 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
| 2023 | Year | 03 | Month | 17 | Day |
Last modified on
| 2023 | Year | 03 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057233
