UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034379 |
|---|---|
| Receipt number | R000038688 |
| Scientific Title | Feasibility study on development of patient question asking support program to prepare for the time of the anti-cancer agent therapy discontinuation |
| Date of disclosure of the study information | 2018/10/04 |
| Last modified on | 2020/04/06 16:14:07 |
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Basic information
Public title
Feasibility study on development of patient question asking support program to prepare for the time of the anti-cancer agent therapy discontinuation
Acronym
Feasibility study on question asking support program for patients
Scientific Title
Feasibility study on development of patient question asking support program to prepare for the time of the anti-cancer agent therapy discontinuation
Scientific Title:Acronym
Feasibility study on question asking support program for patients
Region
| Japan |
Condition
Condition
Colorectal cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The Purpose of this study is to develop a patient question asking support program to promote discussion with oncologists on medical treatment/care after discontinuation of anticancer treatment for patients with advanced/recurrent colorectal cancer and to examine the feasibility of the program.
Basic objectives2
Others
Basic objectives -Others
Feasibility
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Number of questions from patient to doctor
Key secondary outcomes
1) The impression of performance during outpatient consultation after question support (control group is about one week later).
2) The number of utterance during outpatient outpatient consultation after question support (control group is open for about one week).
3) Psychological stress of the Patient
4) Patient's QOL
5) Trust in Doctor
6) Satisfuction with consultation
7) Acceptance of cancer in Patients
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Maneuver |
Interventions/Control_1
Intervention group
Based on the intervention manual, a question asking support program for 40-60min is provided for participants.
Interventions/Control_2
Control group
Treatment as usual.
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)Patient is diagnosed as advanced/recurrence colorectal cancer (colon, rectal cancer)
2)Patient receives third line chemotherapy
3)Patient is over 20 years old.
4)Patient's ECOG score is 0 or 1.
5)Patient gives written informedconsent.
6)Patient has ability to read, write and understand Japanese
Key exclusion criteria
1) It is judged by the attending physician that there is a decline in severe cognitive function such as delirium, dementia
2) Others are judged unsuitable for conducting this test by the attending physician
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Maiko |
| Middle name | |
| Last name | Fujimori |
Organization
National Cancer Center
Division name
Center for Public Health SciencesDivision of Health Care Research, QOL Research Group
Zip code
104-0045
Address
5-1-1 Tsukiji Chuo-ku Tokyo
TEL
03-3547-5201(ext.3320)
mfujimor@ncc.go.jp
Public contact
Name of contact person
| 1st name | Ayako |
| Middle name | |
| Last name | Sato |
Organization
National Cancer Center
Division name
Center for Public Health SciencesDivision of Health Care Research, QOL Research Group
Zip code
104-0045
Address
5-1-1 Tsukiji Chuo-ku Tokyo
TEL
03-3547-5201(ext.3327)
Homepage URL
ncc2018communication@gmail.com
Sponsor or person
Institute
National Cancer Center
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
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
National Cancer Center IRB
Address
5-1-1 Tsukiji Chuo-ku Tokyo
Tel
03-3547-5201
NCC_IRBoffice@ml.res.ncc.go.jp
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
国立がん研究センター中央病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 10 | Month | 04 | 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
Completed
Date of protocol fixation
| 2018 | Year | 08 | Month | 24 | Day |
Date of IRB
| 2018 | Year | 08 | Month | 31 | Day |
Anticipated trial start date
| 2018 | Year | 10 | Month | 05 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 01 | Month | 20 | Day |
Date trial data considered complete
| 2020 | Year | 01 | Month | 20 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 10 | Month | 04 | Day |
Last modified on
| 2020 | Year | 04 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038688
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
