UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038522 |
|---|---|
| Receipt number | R000043904 |
| Scientific Title | Evaluation of the Clinician Collaboration ACP Model Utilizing the Serious Illness Conversation Guide (SICG) in Outpatient Oncology Clinic |
| Date of disclosure of the study information | 2020/02/01 |
| Last modified on | 2024/05/13 10:59:14 |
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Basic information
Public title
Evaluation of the Clinician Collaboration ACP Model Utilizing the Serious Illness Conversation Guide (SICG) in Outpatient Oncology Clinic
Acronym
Evaluation of the ACP model in Outpatient Oncology Clinic
Scientific Title
Evaluation of the Clinician Collaboration ACP Model Utilizing the Serious Illness Conversation Guide (SICG) in Outpatient Oncology Clinic
Scientific Title:Acronym
Evaluation of the ACP model in Outpatient Oncology Clinic
Region
| Japan |
Condition
Condition
Advanced Cancer
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine | Nursing |
| Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study aims to evaluate the effectiveness of advance care planning (ACP) support in collaboration with doctors and nurses utilizing the Serious Illness Conversation Guide (SICG) for patients with advanced cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Patients' quality of life 24 weeks after starting ACP support
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Serious Illness Conversation Program
Interventions/Control_2
Standard Palliative Care and introducing a ACP brochure issued by the Ministry of Health, Labor and Welfare
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
Included when all of the following are met.
1) Patients with a diagnosis of untreatable, metastatic, or recurrent gastrointestinal cancer.
2) Patients with a histopathological diagnosis of gastric, esophageal, biliary, pancreatic, or colorectal cancer (regardless of histological type).
3) Patients who are within 6 weeks (42 days) of initiating palliative primary chemotherapy at Kyoto University Hospital and are able to visit the outpatient clinic.
4) Patients who have received an explanation of the disease diagnosis and palliative treatment.
5) Patients who are at least 20 years of age at the time consent is obtained.
6) Patients who are able to bring a family member to at least one ACP discussion.
7) Patients with an ECOG Performance Status (PS) of 0 to 2.
8) Patients whose written consent to participate in the study has been obtained.
Key exclusion criteria
Excluded when any of the following items apply.
1) Patients with the Distress and Impediment Thermometer (DIT) test score of 4 or more for distress and a score of 3 or more for impediment.
2) Patients who have had an ACP discussion prior to participation in this study, covering the full range of medical condition awareness, prognostic information sharing, values identification, and discussion of desired medical care and care.
3) Patients with higher brain dysfunction (apparent intellectual decline, attention deficits, and dysgraphia).
4) Patients who are unable to speak, read, or write in Japanese.
5) Patients who are judged by the attending physician to be unsuitable to be included in this study.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Sayaka |
| Middle name | |
| Last name | Takenouchi |
Organization
Kyoto University Graduate School of Medicine
Division of Human Health Sciences
Division name
Department of Nursing Ethics
Zip code
606-8507
Address
53 Shogoin Kawahara-cho, Sakyo-ku Kyoto 606-8507, Japan
TEL
075-751-3958
takenouchi.sayaka.6u@kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Sayaka |
| Middle name | |
| Last name | Takenouchi |
Organization
Kyoto University Graduate School of Medicine Division of Human Health Sciences
Division name
Department of Nursing Ethics
Zip code
606-8507
Address
53 Shogoin Kawahara-cho, Sakyo-ku Kyoto 606-8507, Japan
TEL
075-751-3958
Homepage URL
takenouchi.sayaka.6u@kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
KAKENHI
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
Kyoto University
Address
Yoshida Konoe-cho, Sakyo-ku, Kyoto
Tel
075-753-4680
ethcom@kuhp.kyoto-u.ac.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
京都大学医学部附属病院（京都府）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 02 | Month | 01 | 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
61
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
Completed
Date of protocol fixation
| 2020 | Year | 01 | Month | 31 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 09 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 10 | Day |
Date of closure to data entry
| 2022 | Year | 12 | Month | 13 | Day |
Date trial data considered complete
| 2022 | Year | 12 | Month | 13 | Day |
Date analysis concluded
| 2023 | Year | 08 | Month | 21 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 11 | Month | 08 | Day |
Last modified on
| 2024 | Year | 05 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043904
