UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044749 |
|---|---|
| Receipt number | R000050770 |
| Scientific Title | Implementation study of a nurse-led early professional palliative care program for pancreatic cancer patients |
| Date of disclosure of the study information | 2023/10/01 |
| Last modified on | 2025/01/04 09:11:15 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Implementation study of a nurse-led early professional palliative care program for pancreatic cancer patients
Acronym
Implementation study of a nurse-led early professional palliative care program for pancreatic cancer patients
Scientific Title
Implementation study of a nurse-led early professional palliative care program for pancreatic cancer patients
Scientific Title:Acronym
Implementation study of a nurse-led early professional palliative care program for pancreatic cancer patients
Region
| Japan |
Condition
Condition
pancreatic cancer
Classification by specialty
| Nursing |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
o evaluate the efficacy and effectiveness of a nurse-led professional palliative care program for patients with unresectable pancreatic cancer from the early stage of diagnosis based on EBI with the aim of improving patients' QOL, symptom relief, and quality of palliative care.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Quality of life after 1 month of the program
Key secondary outcomes
Quality of life after 3 months of the program
Quality of palliative care after 3 months of the program
Symptoms after 1 month of the program
Holistic distress at 1 month of the program
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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with unresectable pancreatic cancer within 8 weeks of diagnosis who are receiving treatment at the Department of Gastroenterology, University Hospital A
Patients with unresectable pancreatic cancer within 8 weeks of diagnosis who are undergoing treatment at the Department of Gastroenterology, University Hospital A.
The patient is within 8 weeks of diagnosis of unresectable pancreatic cancer at the time of PCT involvement.
Patients who have given consent for PCT nurses to be involved and to participate in the study.
Key exclusion criteria
Patients who are transferred to other hospitals or doctors after the initial involvement of PCT nurses
Patients whose initial treatment is the introduction of oral anticancer drugs
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Mariko |
| Middle name | |
| Last name | Nakano |
Organization
Juntendo University Hospital
Division name
Cancer center
Zip code
113-8431
Address
3-1-3 Hongo Bunkyo-ku, Tokyo 113-8431 JAPAN
TEL
03-5802-8196
mnakano@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Mariko |
| Middle name | |
| Last name | Nakano |
Organization
Juntendo University Hospital
Division name
Cancer center
Zip code
113-8431
Address
3-1-3 Hongo Bunkyo-ku, Tokyo 113-8431 JAPAN
TEL
03-5802-8196
Homepage URL
mnakano@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University Hospital
Institute
Department
Personal name
Funding Source
Organization
Juntendo University 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
Juntendo University Hospital, Hospital Ethics Board
Address
3-1-3 Hongo Bunkyo-ku, Tokyo 113-8431 JAPAN
Tel
03-5802-1584
kenkyu5858@juntendo.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
| 2023 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
None
Publication of results
Unpublished
Result
URL related to results and publications
None
Number of participants that the trial has enrolled
12
Results
FACT-G showed an increase in values after 1 month (median: 71.05) and a decreasing trend after 3 months (median: 63) compared to the beginning of the program (median: 62) (p=0.223) Appropriateness did not show any significant change in values during the QI cycle. For acceptability, nurses' satisfaction did not improve. There was a slight improvement in attainment, from 33.3% in QI Cycle 1 to 44.4% in QI Cycle 4 (9 months after the start of the program).
Results date posted
| 2024 | Year | 07 | Month | 13 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
There were a total of 12 patient participants. 7 males and 5 females, with an average age of 63.75 years.
The health care providers who participated in the program evaluation included 28 nurses (with an average of 10.1 years of experience) and 2 physicians.
Participant flow
Patients who meet the eligibility criteria and are within 8 weeks of diagnosis of advanced pancreatic cancer will be informed by their gastroenterologist about the involvement of a palliative care team nurse and participation in the program. The principal investigator then explained the program and patients who agreed to participate in the program were eligible to participate in the study.
The nurses were the nurses in the gastroenterology ward (with at least two years of experience) and the chemotherapy room nurses who were briefed by the study participants and who gave their consent to participate in the program.
Physicians were eligible to participate in the study if they were practicing physicians treating patients with pancreatic cancer and had given consent to be interviewed for the research program.
Adverse events
none in particular
Outcome measures
Patient outcome measures
FACT-G(Functional Assessment of Cancer Therapy-General)
Symptom Assessment Form
Simplified Ease of Living Questionnaire
Excerpts from the CES-P(Care Evaluation Scale-Patient version, a quality assessment of palliative care).
Nurse outcome measures
Questionnaire (prepared by researcher)
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 28 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 21 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study will use the study by Vanbutsele et al. (2018), which reported improved quality of life with a nurse-led PCT intervention, as the basis for EBI. We will implement an early nurse-led professional palliative care program using an EBI-based protocol for patients with advanced pancreatic cancer within 8 weeks of diagnosis. The program consists of primary assessment and response by ward (chemotherapy room) nurses using a questionnaire, which is shared with PCT nurses, and interviews by PCT nurses using an assessment sheet based on the content of the assessment. This process is carried out during hospitalization and continued during outpatient visits. The implementation strategy is to evaluate the program monthly as a PDSA cycle.
The implementation strategy is to evaluate the program monthly as a PDSA cycle, and the clinical outcome is to measure the quality of life of patients with advanced pancreatic cancer, general distress using a simplified ease of living questionnaire, symptom assessment, and the quality of palliative care. The implementation outcome will be measured as follows: 1)adoption: participating providers who adopt the project/consent to participate in the project; 2) feasibility: percentage of patients who complete the program elements; 3)fidelity: percentage of patients who complete the main program elements (i.e., (1)implementation of specialized palliative care within 8 weeks of diagnosis for patients with advanced pancreatic cancer, (2)completion of the ongoing (4) Appropriateness (5)Acceptance: Evaluation by gastroenterologists and nurses (1-4 scale, interview survey) (6)Achievement or penetration: The percentage of patients with advanced pancreatic cancer who received PCT according to EBI. (6) Reach or penetration: the percentage of patients with advanced pancreatic cancer who were able to have a PCT program in accordance with EBI.
Management information
Registered date
| 2021 | Year | 07 | Month | 03 | Day |
Last modified on
| 2025 | Year | 01 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050770
