UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058571 |
|---|---|
| Receipt number | R000064803 |
| Scientific Title | Development and implementation of a transitional care program (cancer pain management version) to improve the quality of life of adult patients discharged from acute care hospitals |
| Date of disclosure of the study information | 2025/07/23 |
| Last modified on | 2025/07/23 19:36:12 |
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Basic information
Public title
Development and implementation of a transitional care program (cancer pain management version) to improve the quality of life of adult patients discharged from acute care hospitals
Acronym
Development and implementation of a transitional care program (cancer pain management version) for adult patients discharged from acute care hospitals
Scientific Title
Development and implementation of a transitional care program (cancer pain management version) to improve the quality of life of adult patients discharged from acute care hospitals
Scientific Title:Acronym
Development and implementation of a transitional care program (cancer pain management version) for adult patients discharged from acute care hospitals
Region
| Japan |
Condition
Condition
gastrointestinal cancer
Classification by specialty
| Nursing | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To develop a transitional care program (cancer pain management version) that supports cancer pain management in adult patients discharged from acute care hospitals and contributes to pain-free home care, and to implement and evaluate the developed program in the outpatient clinic B of University Hospital A.
Basic objectives2
Others
Basic objectives -Others
To evaluate implementation and clinical outcomes from the implementation of the developed transitional care program and to describe inhibiting and facilitating factors
Trial characteristics_1
Others
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
nurses' confidence in transitional care(Evaluated every month from the start of transitional care. Final evaluation after 4 months)
Key secondary outcomes
Clinical outcomes: quality of life, pain-related self-efficacy, patient experience, changes in pain-related knowledge and behavior, utilization of medical services
Implementation outcomes: fidelity of implementation, fidelity of intervention, feasibility, appropriateness, acceptability, reach
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients
1) Patients who received a new introduction of oral analgesics or treatment with drug modification or titration for the management of cancer pain while hospitalized in the gastroenterology ward of University Hospital A
2) Patients who fall into one of the following categories and have given consent to participate in this study
Patients with pain during palliative screening during hospitalization
Patients with a request for outpatient intervention at the time of discharge from the hospital, and the request includes information on pain management.
Patients for whom the ward nurses felt that pain management was or would be necessary after discharge from the hospital.
3) Patients with a performance status scale of 0, 1, or 2
Nurses
This program will be open to those who meet all of the following criteria
1) Nurses with a Clinical Ladder Level of III or higher and at least 10 years of practical experience
2) Nurses who have held leadership roles in their respective departments and have experience in telephone consultation
Key exclusion criteria
Patients
Persons who are in one of the following situations will not be included in this study.
1) Those who are under 20 years of age
2) Patients who are terminating their consultation at the Department of Gastroenterology, University Hospital A for transfer to another hospital, or who are transferred to another outpatient or house call physician.
3) Patients with cognitive, visual, or auditory dysfunction
4) Pediatric, neuropsychiatric, and obstetric patients
Nursing
No exclusion criteria
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Chizuko |
| Middle name | |
| Last name | Sakashita |
Organization
Kitasato University Hospital
Division name
Nursing Department
Zip code
2520375
Address
1-15-1 Kitasato, Minami-ku, Sagamihara City, Kanagawa, Japan
TEL
81427788111
c.saka@kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Chizuko |
| Middle name | |
| Last name | Sakashita |
Organization
Kitasato University Hospital
Division name
Nursing Department
Zip code
2520375
Address
1-15-1 Kitasato, Minami-ku, Sagamihara City, Kanagawa, Japan
TEL
81427788111
Homepage URL
c.saka@kitasato-u.ac.jp
Sponsor or person
Institute
St. Luke's International University
Institute
Department
Personal name
Chizuko Sakashita
Funding Source
Organization
Japan Academy of Nursing Science
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kitasato university hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
St. Luke's International University
Address
10-1 Akashi-chou, Chuo-ku, Tokyo
Tel
81355502423
kenkyukikaku@luke.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
北里大学病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 07 | Month | 23 | 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
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 05 | Month | 13 | Day |
Date of IRB
| 2025 | Year | 05 | Month | 13 | Day |
Anticipated trial start date
| 2025 | Year | 05 | Month | 25 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 09 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Recruiting and collecting data
Management information
Registered date
| 2025 | Year | 07 | Month | 23 | Day |
Last modified on
| 2025 | Year | 07 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064803
