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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000027207
Receipt No. R000031177
Scientific Title Continuous monitoring with wearable devices on effectiveness in pain management
Date of disclosure of the study information 2017/05/02
Last modified on 2019/05/20

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Basic information
Public title Continuous monitoring with wearable devices on effectiveness in pain management
Acronym Continuous monitoring with wearable devises
Scientific Title Continuous monitoring with wearable devices on effectiveness in pain management
Scientific Title:Acronym Continuous monitoring with wearable devises
Region
Japan

Condition
Condition Cancer
Classification by specialty
Medicine in general
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is, using wearable accelerometer, to evaluate the efficacy
of introducing and increasing of opioids, by measuring activity intensity and quality of life in outpatients who are on
palliative care.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Changes in activity intensity before and after introducing or increasing of strong opioids, using METs(Metabolic equivalents) per day measured with wearable accelerometer.
Key secondary outcomes 1. Changes in the number of steps per day before and after measured with wearable accelerometer.
2. Changes in SF-36 summary score and 8 subscales before and after.
3. Changes in VAS-Pain score before and after.

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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 1. ambulatory cancer patients on treatment over 20 years old (not matter the type of cancer).
2. patients starting or increasing basal strong opioids (morphine, oxycodone, fentanyl, methadone, tapentadol, hydromorphone).
3. patients expected to survive for >6 months.
4. patients with ECOG Performance Status 0 - 1.
5. patients who have given their written consent.
Key exclusion criteria 1. patients who are schduled for receiving radiotherapy for pain relief during observation period.
2. patients who are schduled for hospitalization or receiving surgery during observation period.
3. patients who introduce or increase strong opioids within 6 days after receive highly or moderately emetrogenic anticancer drug.
4. patients who are ineligible for measuring activity intensity due to comorbidity.
5. inappropriate patients for this study judged by research collaborator or physicians.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Hisashi
Middle name
Last name Urusihara
Organization Faculty of Pharmacy, Keio University
Division name Department of Drug Development and Regulatory Science
Zip code 1058512
Address 1-5-30 Shibakouen, Minato-ku, Tokyo 105-8512, Japan
TEL 03-5400-2649
Email urushihara.hisashi@keio.jp

Public contact
Name of contact person
1st name Hisashi
Middle name
Last name Urusihara
Organization Faculty of Pharmacy, Keio University
Division name Department of Drug Development and Regulatory Science
Zip code 1058512
Address 1-5-30 Shibakouen, Minato-ku, Tokyo 105-8512, Japan
TEL 03-5400-2649
Homepage URL
Email urushihara.hisashi@keio.jp

Sponsor
Institute Department of Drug Development and Regulatory Science, Faculty of Pharmacy, Keio University
Institute
Department

Funding Source
Organization JAPAN SOCIETY FOR THE PROMOTION OF SCIENCE
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 for research involving human subjects, Faculty of Pharmacy, Keio University
Address 1-5-30 Shibakouen, Minato-ku, Tokyo 105-8512, Japan
Tel 03-3434-6241
Email skc-soumu@adst.keio.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 国立研究開発法人国立がん研究センター東病院(千葉県)
公益財団法人 がん研究会有明病院(東京都)
越谷市立病院(埼玉県)
関西電力病院(大阪府)

Other administrative information
Date of disclosure of the study information
2017 Year 05 Month 02 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 Enrolling by invitation
Date of protocol fixation
2017 Year 04 Month 21 Day
Date of IRB
2017 Year 03 Month 31 Day
Anticipated trial start date
2017 Year 07 Month 01 Day
Last follow-up date
2020 Year 12 Month 31 Day
Date of closure to data entry
2021 Year 01 Month 31 Day
Date trial data considered complete
2021 Year 01 Month 31 Day
Date analysis concluded
2021 Year 03 Month 31 Day

Other
Other related information Study design:
prospective cohort study

Subjects:
cancer patients who receive palliative care

Measurement:
activity intencity and quality of life

Management information
Registered date
2017 Year 05 Month 01 Day
Last modified on
2019 Year 05 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031177

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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