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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000025322
Receipt No. 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

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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
Email 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
Email amatsuda@med.teikyo-u.ac.jp

Sponsor
Institute Tokyo Medical & Dental University
Liaison Psychiatry & Palliative Medicine
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
Address
Tel
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029126

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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