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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013216
Receipt No. R000015421
Scientific Title Patient-physician communication in oncology
Date of disclosure of the study information 2014/02/21
Last modified on 2014/02/21

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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
Email 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
Email mfujimor@ncc.go.jp

Sponsor
Institute ational Cancer Center Hospital East
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015421

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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