UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033612 |
|---|---|
| Receipt number | R000038002 |
| Scientific Title | A randomized controlled trial of integrated empathic communication support program to promote end of life discussion among rapidly progressive cancer patient, caregiver and physician |
| Date of disclosure of the study information | 2018/08/02 |
| Last modified on | 2023/02/06 09:45:23 |
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Basic information
Public title
A randomized controlled trial of integrated empathic communication support program to promote end of life discussion among rapidly progressive cancer patient, caregiver and physician
Acronym
Research to support communication with doctors
Scientific Title
A randomized controlled trial of integrated empathic communication support program to promote end of life discussion among rapidly progressive cancer patient, caregiver and physician
Scientific Title:Acronym
Research to support communication with doctors
Region
| Japan |
Condition
Condition
Pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to verify the effectiveness of promoting desirable communication between patients / companions / physicians by developing communication, coaching and programs to patients / companions and doctors.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase III
Assessment
Primary outcomes
It is the difference between the group of the difference before and after the average value of the average value of the doctor's SHARE impression rating to be evaluated at the outpatient examination (the third week of the first chemotherapy 2) before and after the communication intervention (after opening the control group for about one week) is there.
Key secondary outcomes
For doctor / patient behavior, evaluate using RIAS at outpatient examination after communication intervention (control group is emptied about one week).
In addition, the following items are evaluated at each stage of 3, 6, 12, 24, and 36 months after the outpatient examination at registration, after communication intervention (after opening the control group for about one week). During the hospital visit during the hospital visit during the visit, postmortem at the post.
Patient
1) Psychological stress of the patient
2) patient's QOL
3) Trust in doctors
4) Satisfaction with examination
5) Acceptance of cancer in patients
6) Relevance of intervention method: completion rate, intervention time, usefulness, satisfaction, burden feeling
7) Recognition of patient's healing
8) Medical use: Anticancer treatment after standard treatment, treatment with invasion, emergency delivery, ward hospitalization, out-of-ward examination, telephone consultation, hospice ward use, home medical examination visit, survival period
Caregiver
1) QOL of caregiver
2) Psychological stress of caregivers
3) Satisfaction to the examination
4) Recognition of patient's healing
5) Relevance of intervention method: completion rate, usefulness, satisfaction, burden feeling
Doctor
1) Relevance of the intervention method: completion rate, usefulness, satisfaction, burden feeling
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Maneuver |
Interventions/Control_1
Intervention group
Communication support for physicians: Using the communication skills training (SHARE-CST) text book and DVD, lecture about the communication desired by the patient, how to use the Question Prompt List (QPL: specific series of questions to encourage questioning physicians)(60 min), simulated interviews using a scenario (Two sets of 60 minutes), will be held. Interposer will be the person who completed the facilitator training program.
Communication support for patients and their caregivers: Based on the intervention manual (see attached document), the interposer will consider intentions about the care after the standard treatment, then conduct 40-60 min long communication support including role plays in order to communicate their intentions with their physician. This intervention will be held before their meeting with the physician. Within this process, psychological support will be provided when necessary.The interposer will be a clinical psychologists, oncologists, nurse, counselor who competed the facilitator training program.
Interventions/Control_2
Contol group
Intervention for physicians: Since there is no standard interventions for communication, not intervention will be done.
Interventions for patients and caregivers: Since there is no standard interventions for communication, not intervention will be done.
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
Patient
1) Disease (cancer site)
Patient is diagnosed as pancreatic cancer (adenocarcinoma)
2) Extent of disease
Patients with unresectable pancreatic cancer (UICC stage III or IV) or patients that started their primary chemotherapy for postoperative reccurence and are scheduled with second course chemotherapy.
3) Age
Ages above 20
4)PS:Performance status
ECOG performance status score:0-1
5) Written informed consent for participating in the study is obtained from the patient
6) Receive periodic anticancer drug treatment from the physician participating in this study.
7) Understands Japanese.
Caregiver
1) Age
Ages above 20
2) Person who will accompany the patient participating in this study, on the day of the intervention, and the recording day (which is the main evaluation of this study).
3) Written informed consent for participating in the study is obtained from the patient's caregiver.
4) Understands Japanese
Physician
1) The physician who is mainly engaged in the anticancer drug treatment of the pancreatic cancer patient whom will participate in this study.
2) Written informed consent for participating in the study is obtained from the physician.
Key exclusion criteria
Patients/companions who fall under any of the following are excluded. Do not set exclusion criteria for physicians.
1) Degradation of severe cognitive function due to delirium, dementia, etc. is recognized.
2) It is difficult to operate the touch panel.
3) In addition, it is judged unsuitable for practicing this exam by physicians.
Target sample size
560
Research contact person
Name of lead principal investigator
| 1st name | Maiko |
| Middle name | |
| Last name | Fujimori |
Organization
National Cancer Center Institute for Cancer Control
Division name
Division of Supportive Care, Survivorship and Translational Research/ Division of Behavioral Sciences
Zip code
104-0045
Address
5-1-1 Tsukiji Chuo-ku Tokyo
TEL
03-3547-5201
mfujimor@ncc.go.jp
Public contact
Name of contact person
| 1st name | Maiko |
| Middle name | |
| Last name | Fujimori |
Organization
National Cancer Center Institute for Cancer Control
Division name
Division of Supportive Care, Survivorship and Translational Research
Zip code
104-0045
Address
5-1-1 Tsukiji Chuo-ku Tokyo
TEL
03-3547-5201
Homepage URL
mfujimor@ncc.go.jp
Sponsor or person
Institute
National Cancer Center
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
National Cancer Center Hospital East
The Cancer Institute Hospital of JFCR
Kanagawa Cancer Center
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Cancer Center IRB
Address
5-1-1 Tsukiji Chuo-ku Tokyo
Tel
03-3547-5201
irst@ml.res.ncc.go.jp
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
国立がん研究センター中央病院（東京都）
国立がん研究センター東病院（千葉県）
がん研究有明病院（東京都）
神奈川県立がんセンター（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 08 | Month | 02 | 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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 07 | Month | 04 | Day |
Date of IRB
| 2018 | Year | 06 | Month | 28 | Day |
Anticipated trial start date
| 2018 | Year | 08 | Month | 03 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 08 | Month | 02 | Day |
Last modified on
| 2023 | Year | 02 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038002
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
