Unique ID issued by UMIN | UMIN000033612 |
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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 |
A randomized controlled trial of integrated empathic communication support program to promote end of life discussion among rapidly progressive cancer patient, caregiver and physician
Research to support communication with doctors
A randomized controlled trial of integrated empathic communication support program to promote end of life discussion among rapidly progressive cancer patient, caregiver and physician
Research to support communication with doctors
Japan |
Pancreatic cancer
Hepato-biliary-pancreatic medicine |
Malignancy
NO
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.
Efficacy
Confirmatory
Phase III
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.
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
Interventional
Parallel
Randomized
Cluster
Open -but assessor(s) are blinded
No treatment
2
Educational,Counseling,Training
Maneuver |
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.
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.
20 | years-old | <= |
Not applicable |
Male and Female
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.
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.
560
1st name | Maiko |
Middle name | |
Last name | Fujimori |
National Cancer Center Institute for Cancer Control
Division of Supportive Care, Survivorship and Translational Research/ Division of Behavioral Sciences
104-0045
5-1-1 Tsukiji Chuo-ku Tokyo
03-3547-5201
mfujimor@ncc.go.jp
1st name | Maiko |
Middle name | |
Last name | Fujimori |
National Cancer Center Institute for Cancer Control
Division of Supportive Care, Survivorship and Translational Research
104-0045
5-1-1 Tsukiji Chuo-ku Tokyo
03-3547-5201
mfujimor@ncc.go.jp
National Cancer Center
Japan Agency for Medical Research and Development
Japanese Governmental office
National Cancer Center Hospital East
The Cancer Institute Hospital of JFCR
Kanagawa Cancer Center
National Cancer Center IRB
5-1-1 Tsukiji Chuo-ku Tokyo
03-3547-5201
irst@ml.res.ncc.go.jp
NO
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)
2018 | Year | 08 | Month | 02 | Day |
Unpublished
No longer recruiting
2018 | Year | 07 | Month | 04 | Day |
2018 | Year | 06 | Month | 28 | Day |
2018 | Year | 08 | Month | 03 | Day |
2023 | Year | 03 | Month | 31 | Day |
2018 | Year | 08 | Month | 02 | Day |
2023 | Year | 02 | Month | 06 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038002
Research Plan | |
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Registered date | File name |
Research case data | |
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