UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048960 |
|---|---|
| Receipt number | R000055785 |
| Scientific Title | Feasibility of a family-integrated advance care planning intervention for people with advanced cancer in Japan |
| Date of disclosure of the study information | 2022/10/31 |
| Last modified on | 2024/03/21 09:35:50 |
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Basic information
Public title
Feasibility of a family-integrated advance care planning intervention for people with advanced cancer in Japan
Acronym
Feasibility of a family-integrated advance care planning intervention for people with advanced cancer in Japan
Scientific Title
Feasibility of a family-integrated advance care planning intervention for people with advanced cancer in Japan
Scientific Title:Acronym
Feasibility of a family-integrated advance care planning intervention for people with advanced cancer in Japan
Region
| Japan |
Condition
Condition
advanced cancer
Classification by specialty
| Medicine in general |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This mixed-methods study aims to examine the feasibility, fidelity and acceptability in the delivery of the family-integrated ACP intervention for use in clinical practice in Japan.
Basic objectives2
Others
Basic objectives -Others
This study also explores the change process in the delivery of the intervention.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Feasibility: the number of dyads (people with advanced cancer and their family members) who are approached, consent and complete the intervention.
Fidelity: the extent of which healthcare professionals deliver components of the intervention
Acceptability: the extent of which patients and family members value the intervention is useful, recommendable, as well as the extent of distress
Change process: interactions among patients, family members and healthcare professionals due to the intervention
These are evaluated by questionnaires administered straight after the intervention as well as interviews conducted straight after or on participants' convenient occasions.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
1. Training program for healthcare professionals
The researcher will hold a training session regarding advance care planning at the study site. The training program is estimated to take three hours including lectures and role-plays using a conversation guide. The participants will have access to the researcher, either by e-mail, phone or in person, if they have queries about the contents through discussions with individuals with advanced cancer and their family members. The researcher will stay at the study site during the research term.
2. Advance care planning conversation using a conversation guide
People who consent to the study participation will be invited to have an ACP conversation. A conversation guide will be used to proceed advance care planning conversation. This conversation will be held among patients with advanced cancer, their family members and trained healthcare professionals. The conversation is estimated to take place once, for 20 to 60 minutes.
Interventions/Control_2
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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Inclusion criteria for people with advanced cancer
1) Diagnosed with advanced cancer
2) Eighteen years old or above
3) Having decisional capacity judged by the attending physician
4) HCPs responding NO to the surprise question
5) Able to identify family members for having ACP discussions together
6) Able and willing to provide written informed consent
Inclusion criteria for family members
1) Nominated by a person diagnosed with advanced cancer for having ACP discussion together
2) Eighteen years old or above
3) Able and willing to provide written informed consent
Inclusion criteria for HCPs
1) HCPs (e.g. physicians, nurses, and medical social workers) working at the department described above
2) Able and willing to provide written informed consent
Key exclusion criteria
People with advanced cancer and their family members who are assessed as not eligible for the study by their attending physician (e.g. too ill). Moreover, people who are assessed that the delivery of the ACP intervention may result in high levels of distress will be excluded. There are no exclusion criteria for HCPs.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Megumi |
| Middle name | |
| Last name | Kishino |
Organization
King's College London
Division name
Cicely Saunders Institute
Zip code
SE5 9PJ
Address
Bessemer Road, London, UK SE5 9PJ
TEL
+44(0)2078485516
megumi.kishino@kcl.ac.uk
Public contact
Name of contact person
| 1st name | Megumi |
| Middle name | |
| Last name | Kishino |
Organization
King's College London
Division name
Cicely Saunders Institute
Zip code
SE5 9PJ
Address
Bessemer Road, London, UK SE5 9PJ
TEL
07089896116
Homepage URL
megumi.kishino@kcl.ac.uk
Sponsor or person
Institute
King's College London
Institute
Department
Personal name
Funding Source
Organization
Japan Hospice Palliative Care Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
King's College London
Address
57 Waterloo Road London, SE1 8WA
Tel
+44 (0)20 7836 5454
rec@kcl.ac.uk
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
筑波大学附属病院（茨城県）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 10 | Month | 31 | 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
Completed
Date of protocol fixation
| 2022 | Year | 09 | Month | 17 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 28 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 05 | 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
| 2022 | Year | 09 | Month | 19 | Day |
Last modified on
| 2024 | Year | 03 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055785
