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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000033612
Receipt No. R000038002
Official scientific title of the study 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 2018/08/02

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Basic information
Official scientific title of the study A randomized controlled trial of integrated empathic communication support program to promote end of life discussion among rapidly progressive cancer patient, caregiver and physician
Title of the study (Brief title) 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 Maiko Fujimori
Organization National Cancer Center
Division name Center for Public Health SciencesDivision of Health Care Research, QOL Research Group
Address 5-1-1 Tsukiji Chuo-ku Tokyo
TEL 03-3547-5201
Email mfujimor@ncc.go.jp

Public contact
Name of contact person Ayako Sato
Organization National Cancer Center
Division name Center for Public Health SciencesDivision of Health Care Research, QOL Research Group
Address 5-1-1 Tsukiji Chuo-ku Tokyo
TEL 03-3547-5201
Homepage URL
Email ncc2018communication@gmail.com

Sponsor
Institute National Cancer Center
Institute
Department

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)

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)
がん研究会有明病院(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

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 07 Month 04 Day
Anticipated trial start date
2018 Year 08 Month 02 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 08 Month 02 Day
Last modified on
2018 Year 08 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038002

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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