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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000034379
Receipt No. 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 2019/05/24

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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
Middle name
Last name Maiko Fujimori
Organization National Cancer Center
Division name Center for Public Health SciencesDivision of Health Care Research, QOL Research Group
Zip code
Address 5-1-1 Tsukiji Chuo-ku Tokyo
TEL 03-3547-5201(ext.3320)
Email mfujimor@ncc.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ayako Sato
Organization National Cancer Center
Division name Center for Public Health SciencesDivision of Health Care Research, QOL Research Group
Zip code
Address 5-1-1 Tsukiji Chuo-ku Tokyo
TEL 03-3547-5201(ext.3327)
Homepage URL
Email ncc2018communication@gmail.com

Sponsor
Institute National Cancer Center
Institute
Department

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
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 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 No longer recruiting
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
2020 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
2018 Year 10 Month 04 Day
Last modified on
2019 Year 05 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038688

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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