UMIN-CTR Clinical Trial

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)
Email	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
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	National Cancer Center IRB
Address	5-1-1 Tsukiji Chuo-ku Tokyo
Tel	03-3547-5201
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000038688