UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035817 |
|---|---|
| Receipt number | R000040805 |
| Scientific Title | Compassionate verbal and non-verbal communication skills on prognostic disclosure to cancer patients |
| Date of disclosure of the study information | 2019/02/20 |
| Last modified on | 2020/08/19 10:46:34 |
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Basic information
Public title
Compassionate verbal and non-verbal communication skills on prognostic disclosure to cancer patients
Acronym
Communication on prognostic disclosure
Scientific Title
Compassionate verbal and non-verbal communication skills on prognostic disclosure to cancer patients
Scientific Title:Acronym
Communication on prognostic disclosure
Region
| Japan |
Condition
Condition
Cancer
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To explore if the addition of worst/bast cases on the median and typical range and/or hope/prepare statement can convey compassion, decrease anxiety, and clinician trust on prognostic disclosure.
To explore if slow rather than rapid communication can convey compassion, decrease anxiety, and clinician trust on prognostic disclosure.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Physician Compassionate Score
Key secondary outcomes
Six basic emotions
Anxiety
Clinician trust
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Verbal:
Best/Worst cases +/-
Interventions/Control_2
Verbal:
Hope/Prepare statement +/-
Interventions/Control_3
Non-verbal:
Neither Best/Worst nor Hope/Prepare statements: Slow/rapid
Interventions/Control_4
Non-verbal:
Both Best/Worst and Hope/Prepare statements: Slow/rapid
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
Outpatients of age 20 or older who are receiving care for cancer
Key exclusion criteria
Those who did not agree to participate
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Masanori |
| Middle name | |
| Last name | Mori |
Organization
Seirei Mikatahara General Hospital
Division name
Department of Clinical Laboratory
Zip code
433-8558
Address
3453 Mikataharacho, Kita-ku, Hamamatsu, JAPAN
TEL
0534361251
masanori.mori@sis.seirei.or.jp
Public contact
Name of contact person
| 1st name | Masanori |
| Middle name | |
| Last name | Mori |
Organization
Seirei Mikatahara General Hospital
Division name
Department of Clinical Laboratory
Zip code
433-8558
Address
3453 Mikataharacho, Kita-ku, Hamamatsu, JAPAN
TEL
0534361251
Homepage URL
masanori.mori@sis.seirei.or.jp
Sponsor or person
Institute
Seirei Mikatahara General Hospital
Institute
Department
Personal name
Funding Source
Organization
Health, Labour, and Welfare Sciences Research Grant
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
Seirei Mikatahara General Hospital
Address
3453 Mikataharacho, Kita-ku, Hamamatsu, JAPAN
Tel
0534361251
NA
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
| 2019 | Year | 02 | Month | 20 | Day |
Related information
URL releasing protocol
Not applicable
Publication of results
Unpublished
Result
URL related to results and publications
Not applicable
Number of participants that the trial has enrolled
208
Results
Unpublished
Results date posted
| 2020 | Year | 08 | Month | 19 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Unpublished
Participant flow
Unpublished
Adverse events
Unpublished
Outcome measures
Unpublished
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2019 | Year | 02 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 02 | Month | 20 | Day |
Last follow-up date
| 2019 | Year | 02 | Month | 25 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 02 | Month | 08 | Day |
Last modified on
| 2020 | Year | 08 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040805
