UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052877 |
|---|---|
| Receipt number | R000060326 |
| Scientific Title | The effectiveness of patient reported outcome (PRO) in palliative care units : a cluster randomized controlled trial |
| Date of disclosure of the study information | 2024/01/24 |
| Last modified on | 2026/04/08 18:15:02 |
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Basic information
Public title
The effectiveness of patient reported outcome (PRO) in palliative care units : a cluster randomized controlled trial
Acronym
The effectiveness of patient reported outcome (PRO) in palliative care units : a cluster randomized controlled trial
Scientific Title
The effectiveness of patient reported outcome (PRO) in palliative care units : a cluster randomized controlled trial
Scientific Title:Acronym
The effectiveness of patient reported outcome (PRO) in palliative care units : a cluster randomized controlled trial
Region
| Japan |
Condition
Condition
Cancer patients admitted to the Palliative Care Unit
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine | Pneumology |
| Hematology and clinical oncology | Geriatrics | Nursing |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the effectiveness of Patient-Reported Outcomes in cancer patients admitted to a palliative care unit.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The Feeling Heard and Understood: FHU is a measure of trust between patients and health care providers in palliative care. FHU is evaluated at admission, one week, and two weeks , and the amount of change over time in the mean of the observation and PRO utilization periods are compared.
Key secondary outcomes
Secondary outcome measures included changes in healthcare providers' perceptions of patient-centered care before and after utilization of PROs, and changes in patients' quality of life from the time of admission to 2 weeks after admission.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Observation period group: Provide usual care at each facility.
Feeling Heard and Understood (FHU), EORTC-QLQ-C15PAL assessment: On admission, 1 and 2 weeks.
Interventions/Control_2
PRO utilization period group: Integrated Palliative care Outcome Scale (IPOS) is used for listening and care at admission, 1 week, and 2 weeks.
Feeling Heard and Understood (FHU), EORTC-QLQ-C15PAL assessment: On admission, 1 and 2 weeks
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. All patients admitted to the palliative care units of the health care institutions participating in the study during the study period.
2. Patients who have given consent for the study.
3. Patients 20 years of age and older.
4. Patients who can converse in Japanese.
Key exclusion criteria
1. Patients with obvious disturbance of consciousness.
2. Patients who the physician or nurse practitioner determines are not appropriate for the study.
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Mitsunori |
| Middle name | |
| Last name | Miyashita |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Palliative Nursing, Health Sciences
Zip code
980-8575
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, 980-8575, Japan
TEL
022-717-7924
miya@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Tomoko |
| Middle name | |
| Last name | Shigeno |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Palliative Nursing, Health Sciences
Zip code
980-8575
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, 980-8575, Japan
TEL
022-717-7924
Homepage URL
tshigeno@med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Graduate School of Medicine
Institute
Department
Personal name
Mitunori Miyashita
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee Tohoku University Graduate School of Medicine
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, 980-8575, Japan
Tel
022-717-8007
med-kenkyo@grp.tohoku.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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 01 | Month | 24 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-bin/ctr/ctr_up_reg_f3.cgi
Publication of results
Unpublished
Result
URL related to results and publications
Not available
Number of participants that the trial has enrolled
345
Results
No statistically significant differences were observed between the control and intervention periods in the primary outcome, Feeling Heard and Understood (FHU). Similarly, no significant differences were found in quality of life as measured by the EORTC QLQ-C15-PAL. However, the implementation of patient-reported outcomes significantly improved nurses' perceptions of their ability to deliver patient-centered care.
Results date posted
| 2026 | Year | 04 | Month | 08 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The mean age of participants was approximately 78 years. Baseline characteristics, including sex, primary diagnosis, and reason for admission, were comparable between the control and intervention periods. However, significant differences were observed in AKPS scores and reasons for admission between periods.
Participant flow
A total of 693 patients were admitted during the study period, of whom 345 met the eligibility criteria and were enrolled in the study. At admission, 343 patients were able to complete the PRO assessment. At the two-week follow-up, 131 patients remained able to complete the assessment.
Adverse events
No adverse events related to the study were observed. The intervention was non-invasive and posed minimal risk to participants.
Outcome measures
The primary outcome was the Feeling Heard and Understood (FHU) scale, which assesses patient-provider communication and trust. FHU was measured at baseline, 1 week, and 2 weeks after admission.
Secondary outcomes included quality of life measured by the EORTC QLQ-C15-PAL and nurses' perceptions of the clinical utility of PRO implementation. The EORTC QLQ-C15-PAL was assessed at baseline, 1 week, and 2 weeks, and nurses' perceptions were evaluated before and after the intervention.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 12 | Month | 18 | Day |
Date of IRB
| 2024 | Year | 01 | Month | 24 | Day |
Anticipated trial start date
| 2024 | Year | 02 | Month | 15 | Day |
Last follow-up date
| 2024 | Year | 07 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 11 | Month | 22 | Day |
Last modified on
| 2026 | Year | 04 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060326
