UMIN-CTR Clinical Trial

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 Tomohiro Middle name Last name Segami
Organization	Sapporo Medical University
Division name	Clinical Trial Center
Zip code	0608543
Address	S-1, W-16, Chuo-ku Sapporo
TEL	011-611-2111
Homepage URL
Email	rskk@sapmed.ac.jp

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）、静岡県立静岡がんセンター（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	Enrolling by invitation
Date of protocol fixation	2019 Year 05 Month 13 Day
Date of IRB	2019 Year 05 Month 16 Day
Anticipated trial start date	2020 Year 02 Month 01 Day
Last follow-up date	2023 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	2021 Year 02 Month 01 Day

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