UMIN-CTR Clinical Trial

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
Email	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
Email	shiori.y@med.tohoku.ac.jp

Sponsor
Institute	Tohoku University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000043689