UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001047
Receipt No. R000001254
Scientific Title Cancer patient and family perception of the usefulness of a question prompt sheet during important consultation
Date of disclosure of the study information 2008/02/21
Last modified on 2009/02/23

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Cancer patient and family perception of the usefulness of a question prompt sheet during important consultation
Acronym Cancer patient and family perception of the usefulness of a question prompt sheet during important consultation
Scientific Title Cancer patient and family perception of the usefulness of a question prompt sheet during important consultation
Scientific Title:Acronym Cancer patient and family perception of the usefulness of a question prompt sheet during important consultation
Region
Japan

Condition
Condition lung, gastric, colorectal, esophageal cancer
Classification by specialty
Gastroenterology Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To determine the usefulness of a question prompt sheet for cancer patient and family communication with physicians
Basic objectives2 Others
Basic objectives -Others the usefulness of a question prompt sheet
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The usefulness of a question prompt sheet/ hospital introduction sheet (3 items; 11 Likert scale)
" To understand the treatment plan, the sheet helped me to ask questions to the physician."
" To understand the treatment plan, the sheet was helpful."
" I will use the sheet again."
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 Hospital introduction sheet
+ Question prompt sheet
Interventions/Control_2 Hospital introduction sheet
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 Patients
1.Patients with advanced cancer (lung, gastric, colorectal, esophageal cancer ) attending their first important consultation with an oncologist after diagnosis
2.Patients who were informed of cancer diagnosis

Family
1. Patient's family
Key exclusion criteria Patients
1.Patients with cognitive dysfunction
2.Patients with serious physical problems recognized by the primary physician or researchers
3.Patients with serious psychological distress recognized by the primary physician or researchers
4.Patients who are not able to communicate in Japanese

Family
Same as patients' exclusion criteria
Target sample size 260

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yosuke Uchitomi
Organization Research Center for Innovative Oncology, National Cancer Center Hospital East
Division name Psycho-Oncology Division
Zip code
Address 6-5-1, Kashiwanoha, Kashiwa, Chiba, Japan
TEL 04-7134-7013
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yuki Shirai
Organization Research Center for Innovative Oncology, National Cancer Center Hospital East
Division name Psycho-Oncology Division
Zip code
Address 6-5-1, Kashiwanoha, Kashiwa, Chiba, Japan
TEL 04-7134-7013
Homepage URL
Email

Sponsor
Institute Research Center for Innovative Oncology, National Cancer Center Hospital East
Institute
Department

Funding Source
Organization Grant from Health and Labor Sciences Research Grants, the third-term comprehensive control research for cancer
Organization
Division
Category of Funding Organization
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

Other administrative information
Date of disclosure of the study information
2008 Year 02 Month 21 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
2007 Year 12 Month 19 Day
Date of IRB
Anticipated trial start date
2008 Year 02 Month 01 Day
Last follow-up date
2008 Year 12 Month 01 Day
Date of closure to data entry
2009 Year 01 Month 01 Day
Date trial data considered complete
2009 Year 02 Month 01 Day
Date analysis concluded
2009 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date
2008 Year 02 Month 21 Day
Last modified on
2009 Year 02 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001254

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.