UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062643 |
|---|---|
| Receipt number | R000071704 |
| Scientific Title | CHQOL Study (Cyclic Hematology Care and Quality of Life Study) |
| Date of disclosure of the study information | 2026/10/01 |
| Last modified on | 2026/08/21 10:42:05 |
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Basic information
Public title
Plain-language study title: Observational Study of Hematologic Care and Quality of Life
Acronym
CHQOL Study (Cyclic Hematology Care and Quality of Life Study)
Scientific Title
CHQOL Study (Cyclic Hematology Care and Quality of Life Study)
Scientific Title:Acronym
CHQOL Study (Cyclic Hematology Care and Quality of Life Study)
Region
| Japan |
Condition
Condition
Hematologic Diseases (Hematologic Malignancies and Non-malignant Hematologic Disorders)
Classification by specialty
| Medicine in general | Hematology and clinical oncology | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To longitudinally assess clinical information, treatment decision-making, health status, and quality of life in patients with hematologic diseases to improve patient-centered care and regional care coordination.
Basic objectives2
Others
Basic objectives -Others
To examine how patients' involvement in treatment decisions, health status, and quality of life relate to treatment continuity, safety, outcomes, and care in their local community.
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Total SDM-Q-9 score (range, 0-45) measured at the initial visit after study enrollment, before or at the time of the initial treatment decision.
The SDM-Q-9 is a 9-item patient-reported questionnaire assessing the patient's perceived involvement in shared decision-making; each item is scored from 0 to 5.
Key secondary outcomes
1. QOL-ACD total and domain scores: measured at the initial visit, at major treatment decision-making, before treatment initiation, every 3 months, at treatment completion, at relapse/progression, and every 6 months during follow-up.
2. Longitudinal SDM-Q-9 score change (0-45): measured at major treatment decision-making, treatment completion, and relapse/progression.
3. JCOG-CGA components: G8, IADL, Charlson Comorbidity Index, living situation, and Mini-Cog assessed at the initial visit, major treatment decision-making, every 3 months, treatment completion, relapse/progression, and every 6 months thereafter.
4. Treatment completion, modification, and discontinuation rates: assessed from first-line treatment initiation to completion or discontinuation.
5. Grade >=3 adverse events: assessed by CTCAE v5.0 from each treatment start through treatment completion and during treatment for relapse/progression.
6. Overall survival and progression-free survival: assessed from enrollment to death or last known alive date, and from enrollment to progression, relapse, or death, whichever occurs first.
7. Cyclic outpatient care outcomes: reverse-referral, re-referral, emergency readmission, and local-care completion rates assessed from enrollment through follow-up.
8. Health-economic measures: DPC code, hospital length of stay, DPC bundled reimbursement points, and fee-for-service-equivalent reimbursement difference assessed through follow-up.
9. Associations of SDM-Q-9: associations with QOL-ACD at each assessment and with treatment completion and grade >=3 adverse events through first-line treatment completion.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Age 18 years or older at enrollment.
2. Diagnosis of a malignant or non-malignant hematologic disease and receiving follow-up, treatment, or ongoing care at the Department of Hematology, St. Mary's Hospital.
3. Written informed consent obtained voluntarily from the participant or legally authorized representative after adequate explanation of the study.
4. Able to complete the SDM-Q-9, JCOG-CGA, and QOL-ACD questionnaires independently or through an interviewer.
Key exclusion criteria
1. Unable to obtain written informed consent for study participation from the participant or legally authorized representative.
2. Lacking capacity to provide consent because of cognitive impairment or other reasons, and unable to obtain consent from a legally authorized representative.
3. Considered inappropriate for study participation by the principal investigator or a subinvestigator.
Target sample size
1500
Research contact person
Name of lead principal investigator
| 1st name | SATOSHI |
| Middle name | |
| Last name | YAMASAKI |
Organization
St. Mary's Hospital
Division name
Hematology
Zip code
8300048
Address
422 Tsufukuhonmachi Kurume
TEL
0942353322
sa-yamasaki@st-mary-med.or.jp
Public contact
Name of contact person
| 1st name | SATOSHI |
| Middle name | |
| Last name | YAMASAKI |
Organization
St. Mary's Hospital
Division name
Hematology
Zip code
8300048
Address
422 Tsufukuhonmachi Kurume
TEL
0942353322
Homepage URL
sa-yamasaki@st-mary-med.or.jp
Sponsor or person
Institute
St. Mary's Hospital
Institute
Department
Personal name
SATOSHI YAMASAKI
Funding Source
Organization
St. Mary's Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB, St. Mary's Hospital
Address
422 Tsufukuhonmachi Kurume
Tel
0942353322
sa-yamasaki@st-mary-med.or.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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 10 | 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
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 | 07 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2034 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a non-interventional prospective observational study using routine clinical data and patient-reported questionnaires (SDM-Q-9, JCOG-CGA, and QOL-ACD).
De-identified data will be collected by linking the electronic medical record and a clinical data collection system.
Study participation requires no additional invasive procedures or treatment interventions.
Written informed consent will be obtained from each participant or legally authorized representative.
Data will be stored on secure institutional servers, and only de-identified data will be shared with collaborating institutions.
Management information
Registered date
| 2026 | Year | 08 | Month | 21 | Day |
Last modified on
| 2026 | Year | 08 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071704
