UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062741 |
|---|---|
| Receipt number | R000069693 |
| Scientific Title | A Randomized Controlled Trial of a Combined Life Review and Serious Illness Conversation Intervention to Improve Spiritual Well-being in People with Advanced Cancer |
| Date of disclosure of the study information | 2026/08/31 |
| Last modified on | 2026/08/31 08:55:21 |
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Basic information
Public title
A Randomized Controlled Trial of a Combined Life Review and Serious Illness Conversation Intervention to Improve Spiritual Well-being in People with Advanced Cancer
Acronym
IKIGAI Study
Scientific Title
A Randomized Controlled Trial of a Combined Life Review and Serious Illness Conversation Intervention to Improve Spiritual Well-being in People with Advanced Cancer
Scientific Title:Acronym
LIM+SICG RCT
Region
| Japan |
Condition
Condition
Patients with end-stage GI cancer
Classification by specialty
| Hematology and clinical oncology | Nursing |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To determine whether a two-step communication intervention integrating LIM and SICG improves spiritual well-being (SWB) at 12 weeks compared with usual care among patients with advanced gastrointestinal cancer initiating first-line palliative chemotherapy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in spiritual well-being (FACIT-Sp score) from baseline (T0) to 12 weeks (T3).
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Step 1 Life Review Interview Method (LIM)
A nurse conducts a LIM interview to help the patient reflect on their life experiences and articulate their values, meaning, and beliefs.
Step 2 Serious Illness Conversation Guide (SICG)
A conversation involving the patient, family members, and a nurse is conducted using the SICG to discuss future care and treatment in light of the patient's values.
Follow-up
Brief telephone follow-ups are conducted at 12 and 24 weeks after the intervention to support ongoing conversations about care consistent with the patient's values.
Interventions/Control_2
Participants receive usual care provided by their treating physician and nurse. In addition, brief telephone follow-up is conducted at the same time points as in the intervention group.
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
1. Patients diagnosed with metastatic or recurrent gastrointestinal cancer that is not amenable to curative treatment.
2. Histologically confirmed gastric, esophageal, biliary tract, pancreatic, or colorectal cancer (any histological subtype).
3. Patients who have initiated first-line palliative chemotherapy at Kyoto University Hospital within 6 weeks (42 days) and are able to attend outpatient visits.
4. Patients who have been informed of their diagnosis and the palliative intent of treatment by their treating physician.
5. Age more than or equal to 20 years at the time of consent.
6. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2.
7. Written informed consent obtained from the patient.
Key exclusion criteria
1. Patients with clinically significant distress, defined as a score of more than or equal to 4 on the distress scale and more than or equal to 3 on the impact scale of the Distress and Impact Thermometer (DIT).
2. Patients who have already experienced a structured conversation with their treating physician or nurse covering illness understanding, prognostic information sharing, clarification of personal values, and discussion of preferred medical care and treatment before enrollment in this study.
3. Patients who are unable to have a family member or other significant person accompany them to discussions regarding medical care or treatment decisions with their physician or nurse.
4. Patients with significant cognitive impairment, including evident cognitive impairment, attention deficits, or memory impairment.
5. Patients who are unable to communicate, read, or write in Japanese.
6. Patients whom the treating physician judges to be inappropriate for participation in this study for any other reason.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Sayaka |
| Middle name | |
| Last name | Takenouchi |
Organization
Graduate School of Medicine, Kyoto University
Division name
Division of Nursing Ethics, Human Health Sciences
Zip code
606-8507
Address
53 Kawahara-cho Shogoin, Sakyo-ku, Kyoto
TEL
0757513958
takenouchi.sayaka.6u@kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Sayaka |
| Middle name | |
| Last name | Takenouchi |
Organization
Graduate School of Medicine, Kyoto University
Division name
Division of Nursing Ethics, Human Health Sciences
Zip code
606-8507
Address
53 Kawahara-cho Shogoin, Sakyo-ku, Kyoto
TEL
0757513958
Homepage URL
takenouchi.sayaka.6u@kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Sayaka Takenouchi
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 Graduate School and Faculty of Medicine, Ethics Committee
Address
53 Kawahara-cho Shogoin, Sakyo-ku, Kyoto, Japan
Tel
0753667618
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
京都府
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 08 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 08 | Month | 06 | Day |
Date of IRB
| 2026 | Year | 08 | Month | 06 | Day |
Anticipated trial start date
| 2026 | Year | 10 | Month | 26 | Day |
Last follow-up date
| 2027 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 08 | Month | 31 | Day |
Last modified on
| 2026 | Year | 08 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069693
