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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000037137
Receipt No. R000042260
Scientific Title Assertive case management intervention for preventing mental ill-health and suicide in advanced cancer patients whithin one year of diagnosis: feasibility study
Date of disclosure of the study information 2019/12/01
Last modified on 2019/12/05

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Basic information
Public title Multifaceted and assertive case management intervention for preventing mental ill-health and crisis in cancer patients whithin one year of diagnosis: feasibility study
Acronym Multifaceted and assertive case management intervention for cancer patients: feasibility study
Scientific Title Assertive case management intervention for preventing mental ill-health and suicide in advanced cancer patients whithin one year of diagnosis: feasibility study
Scientific Title:Acronym Assertive case management intervention for preventing mental ill-health and suicide in cancer patients: feasibility study
Region
Japan

Condition
Condition cancer
Classification by specialty
Gastroenterology Hepato-biliary-pancreatic medicine Pneumology
Hematology and clinical oncology Gastrointestinal surgery Hepato-biliary-pancreatic surgery
Chest surgery Endocrine surgery Breast surgery
Obsterics and gynecology Ophthalmology Dermatology
Psychiatry Oto-rhino-laryngology Orthopedics
Urology Radiology Oral surgery
Neurosurgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 to test feasibility of the maultifaceted intervention for preventing mental ill-health and self-harm in advanced cancer patients within one year of diagnosis
Basic objectives2 Others
Basic objectives -Others feasibility of the intervention
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes proportion of patients with accomplished fae to face intervew by intervention
Key secondary outcomes incident rate of all causes of death, suicide attempt, self-harm, and the assessment scales (MD Anderson Symptom Inventory, EQ-5D, BDI-II, NRS, SCNS-SF34, and an intervention satisfactory scale)

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment

Intervention
No. of arms 1
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 case management intervention
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
90 years-old >=
Gender Male and Female
Key inclusion criteria patients with advanced cancer within one year diagnosis who receive treatment at designated cancer care hospitals; patients who agree to receive the assertive case management intervention for preventing mental ill-health and mental health crisis in patients within one year diagnosis.
Key exclusion criteria patients with consciousness disturbance; patiebts who are unable to communicate with Japanese; patiets who have other reasons for not participating in the trial
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Chiaki
Middle name
Last name Kawanishi
Organization Sapporo Medical University
Division name Department of Neurosychiatry
Zip code 0608543
Address S-1, W-16, Chuo-ku Sapporo
TEL 011-611-2111
Email chiaki.kawanishi@gmail.com

Public contact
Name of contact person
1st name Chiaki
Middle name
Last name Kawanishi
Organization Sapporo Medical University
Division name Department of Neurosychiatry
Zip code 0608543
Address S-1, W-16, Chuo-ku Sapporo
TEL 011-611-2111
Homepage URL
Email chiaki.kawanishi@gmail.com

Sponsor
Institute Sapporo Medical University
Institute
Department

Funding Source
Organization MHLW(Japan)
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 Sapporo Medical University
Address S-1, W-16, Chuo-ku Sapporo
Tel 011-611-2111
Email chiaki.kawanishi@gmail.com

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 札幌医科大学(北海道)、埼玉医科大学国際医療センター(埼玉県)、慶應義塾大学病院(東京都)、静岡県立がんセンター(静岡県)

Other administrative information
Date of disclosure of the study information
2019 Year 12 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 Preinitiation
Date of protocol fixation
2019 Year 05 Month 13 Day
Date of IRB
Anticipated trial start date
2019 Year 10 Month 01 Day
Last follow-up date
2021 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
2019 Year 06 Month 22 Day
Last modified on
2019 Year 12 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042260

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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