UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013216 |
|---|---|
| Receipt number | R000015421 |
| Scientific Title | Patient-physician communication in oncology |
| Date of disclosure of the study information | 2014/02/21 |
| Last modified on | 2014/02/21 15:38:45 |
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Basic information
Public title
Patient-physician communication in oncology
Acronym
Communication in Oncology
Scientific Title
Patient-physician communication in oncology
Scientific Title:Acronym
Communication in Oncology
Region
| Japan |
Condition
Condition
Cancer
Classification by specialty
| Not applicable |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To identify the effects of a communication skills training program for oncologists, developed based on patient preferences regarding oncologists' communication.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Oncologists' communication performances during simulated consultation at baseline and follow-up
Key secondary outcomes
Oncologists' confidence in communicating with patients at baseline and follow-up, patients' depression and anxiety used the Hospital Anxiety and Depression scale (HADS), patients' satisfaction with the consultation, and patients' trust in their oncologist after the consultation
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Maneuver |
Interventions/Control_1
A two-day communication skills training workshop for oncologists
Interventions/Control_2
Usual activity
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
Oncologists:Staff of the National Cancer Center (NCC) Hospital, Tokyo, and Hospital East, Chiba, Japan, were recruited
Patients:Outpatients who were attending follow-up medical appointments with oncologists at the NCC hospitals were recruited after consultation. The eligibility criteria were as follows: patients who had received a diagnosis of cancer; who were 20 years old or older; and who were judged capable of completing the survey physically and cognitively
Key exclusion criteria
Patients: Patients who were uncapable of understanding spoken and written Japanese.
Target sample size
32
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yosuke Uchitomi |
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name
Department of Neuropsychiatry
Zip code
Address
2-5-1 Shikatacho, Kitaku, Okayama
TEL
086-235-7242
uchitomi@okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Maiko Fujimori |
Organization
National Cancer Center Hospital East
Division name
Research Center for Innovative Oncology, Psychooncology Division
Zip code
Address
6-5-1 Kashiwanoha, Kashiwa, Chiba
TEL
042-341-2712
Homepage URL
mfujimor@ncc.go.jp
Sponsor or person
Institute
ational Cancer Center Hospital East
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
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
| 2014 | Year | 02 | Month | 21 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
At the follow-up survey, the performance scores of the IG improved significantly, in terms of their emotional support (p=0.011), setting up a supportive environment (p=0.002), and ability to deliver information (p=0.001), compared with those of the CG. Oncologists in the IG rated higher at follow-up than the CG in terms of their confidence in themselves (p=0.001). In addition, patients who had met oncologists after the CST were significantly less depressed than those of the CG (p=0.027). The CST program did not, however, impact patient satisfaction with their oncologists' style of communication.
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
| 2006 | Year | 05 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2008 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2008 | Year | 09 | Month | 24 | Day |
Date trial data considered complete
| 2009 | Year | 01 | Month | 20 | Day |
Date analysis concluded
| 2013 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 02 | Month | 21 | Day |
Last modified on
| 2014 | Year | 02 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015421
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
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