UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001047 |
|---|---|
| Receipt number | 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 12:27:07 |
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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
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
Sponsor or person
Institute
Research Center for Innovative Oncology, National Cancer Center Hospital East
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001254
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