UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025322 |
|---|---|
| Receipt number | R000029126 |
| Scientific Title | Effect of self-monitoring intervention for Palliative cancer patients : a randomized controlled trial |
| Date of disclosure of the study information | 2016/12/20 |
| Last modified on | 2018/11/13 08:24:00 |
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Basic information
Public title
Effect of self-monitoring intervention for Palliative cancer patients : a randomized controlled trial
Acronym
Effect of self-monitoring intervention for Palliative cancer patients
Scientific Title
Effect of self-monitoring intervention for Palliative cancer patients : a randomized controlled trial
Scientific Title:Acronym
Effect of self-monitoring intervention for Palliative cancer patients
Region
| Japan |
Condition
Condition
Malingant disease
Classification by specialty
| Medicine in general | Hematology and clinical oncology | Psychosomatic Internal Medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness of QOL self-monitoring intervention for palliative cancer patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
QOL (EORTC QLQ-C-Pal)
baseline, 1 weeks, 2 weeks
Key secondary outcomes
QOL (FACIT-Pal),Anxiety and Depression
baseline, 1 weeks, 2 weeks
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
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
No intervention
Interventions/Control_2
QOL self-monitoring intervention
Every day 3 weeks
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.Cancer patients
2.General condition is good enough to participate in this study
3.Predicting prognosis:>= 1 month
Key exclusion criteria
Severe cognitive dysfunction
Severe psychiatric disorder
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Eisuke Matsushima |
Organization
Tokyo Medical & Dental University
Division name
Liaison Psychiatry & Palliative Medicine
Zip code
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo 113-8519
TEL
03-5803-5859
em.lppm@tmd.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ayako Matsuda |
Organization
Teikyo University School of Medicine
Division name
Department of Hygiene and Public Health
Zip code
Address
2-11-1 Kaga, Itabashi-ku, Tokyo 173-8605
TEL
03-3964-1211
Homepage URL
amatsuda@med.teikyo-u.ac.jp
Sponsor or person
Institute
Tokyo Medical & Dental University
Liaison Psychiatry & Palliative Medicine
Institute
Department
Personal name
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
Address
Tel
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
豊島病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 12 | Month | 20 | 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
Terminated
Date of protocol fixation
| 2015 | Year | 04 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 05 | Month | 15 | Day |
Last follow-up date
| 2019 | Year | 03 | 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
| 2016 | Year | 12 | Month | 19 | Day |
Last modified on
| 2018 | Year | 11 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029126
