UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037137 |
|---|---|
| Receipt number | 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 | 2021/02/01 16:08:37 |
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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 |
| Obstetrics 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
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
rskk@sapmed.ac.jp
Sponsor or person
Institute
Sapporo Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042260
