UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058571 |
|---|---|
| Receipt number | R000064803 |
| Scientific Title | Development and Implementation of an Outpatient Transitional Care Program for Cancer Pain Management to Improve Quality of Life of Adult Patients after Discharge from an Acute Care Hospital |
| Date of disclosure of the study information | 2025/07/23 |
| Last modified on | 2026/07/28 09:36:54 |
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Basic information
Public title
Development and Implementation of an Outpatient Transitional Care Program for Cancer Pain Management to Improve Quality of Life of Adult Patients after Discharge from an Acute Care Hospital
Acronym
Development and Implementation of an Outpatient Transitional Care Program for Cancer Pain Management to Improve Quality of Life of Adult Patients after Discharge from an Acute Care Hospital
Scientific Title
Development and Implementation of an Outpatient Transitional Care Program for Cancer Pain Management to Improve Quality of Life of Adult Patients after Discharge from an Acute Care Hospital
Scientific Title:Acronym
Development and Implementation of an Outpatient Transitional Care Program for Cancer Pain Management to Improve Quality of Life of Adult Patients after Discharge from an Acute Care Hospital
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 for cancer pain management that supports adult patients discharged from acute-care hospitals and contributes to pain-free home care, and to implement and evaluate the developed program at the Outpatient Clinic B of University A Hospital
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
Patient Quality of Life
Key secondary outcomes
Clinical outcomes: pain-related self-efficacy, patient experience, changes in pain-related knowledge and behavior, utilization of medical services
nurses' confidence in transitional care(Evaluated every month from the start of transitional care. Final evaluation after 4 months)
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
This study is open to participants who meet all of the following criteria:
1. Patients currently hospitalized in the Gastroenterology Ward at University A Hospital who have been prescribed oral analgesics (including medical opioids and non-opioid analgesics such as nonsteroidal anti-inflammatory drugs) for the management of cancer pain, or patients who scored 1 or higher on the physical distress scale during palliative care screening
2. Patients who meet any of the following criteria and have provided informed consent to participate in this study:
1) Patients who have expressed anxiety about their post-discharge care
2) Patients whom ward nurses believe will require guidance or support regarding self-management of their care after discharge
3. Patients with performance status(PS) 0, 1, or 2 who are capable of independent daily living (including partial assistance from family members, etc.) and self-care during convalescence
Nurses
1. Nurses working in Outpatient Clinic B at University A Hospital, as well as outpatient treatment room nurses responsible for patients visiting that clinic
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
2. Specialist Nurse and Certified Nurse at University A Hospital
This study is open to candidates who meet the following criteria. In Cycle 0 of the QI cycle, the role involves identifying issues in the transitional care program and serving as a role model for other nurses. From Cycle 1 onward, the role involves providing transitional care for complex and challenging cases and serving as a supervisor for other nurses.
1) At least 15 years of practical experience in the field of oncology nursing
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
5) Patients with a life expectancy of one month or less
Nurses
No exclusion criteria
Target sample size
30
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
28
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
The results of this study are scheduled to be published in a journal.
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
| 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
| 2026 | Year | 03 | Month | 03 | Day |
Date of closure to data entry
Date trial data considered complete
| 2026 | Year | 07 | Month | 28 | Day |
Date analysis concluded
| 2026 | Year | 07 | Month | 28 | Day |
Other
Other related information
No special notes.
Management information
Registered date
| 2025 | Year | 07 | Month | 23 | Day |
Last modified on
| 2026 | Year | 07 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000064803
