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A randomized controlled trial of integrated empathic communication support program to promote end of life discussion among rapidly progressive cancer patient, caregiver and physician

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

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000033612
Enrollment
560
Registered
2018-08-02
Start date
2018-08-03
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic cancer

Interventions

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

Sponsors

National Cancer Center
Lead Sponsor
National Cancer Center Hospital East The Cancer Institute Hospital of JFCR Kanagawa Cancer Center
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
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.

Secondary

MeasureTime frame
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

Countries

Japan

Contacts

Public ContactMaiko Fujimori

National Cancer Center Institute for Cancer Control Division of Supportive Care, Survivorship and Translational Research

mfujimor@ncc.go.jp03-3547-5201

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026