UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055961 |
|---|---|
| Receipt number | R000063922 |
| Scientific Title | Intervention of a Nursing Support Program for Work Continuation in Cancer Patients Undergoing Outpatient Treatment: A Randomized Controlled Trial |
| Date of disclosure of the study information | 2024/10/28 |
| Last modified on | 2025/11/04 10:47:08 |
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Basic information
Public title
Intervention of a Nursing Support Program for Work Continuation in Cancer Patients Undergoing Outpatient Treatment: A Randomized Controlled Trial
Acronym
Intervention of a Nursing Support Program for Work Continuation in Cancer Patients Undergoing Outpatient Treatment: A Randomized Controlled Trial
Scientific Title
Intervention of a Nursing Support Program for Work Continuation in Cancer Patients Undergoing Outpatient Treatment: A Randomized Controlled Trial
Scientific Title:Acronym
Intervention of a Nursing Support Program for Work Continuation in Cancer Patients Undergoing Outpatient Treatment: A Randomized Controlled Trial
Region
| Japan |
Condition
Condition
Cancer
Classification by specialty
| Medicine in general | Surgery in general | Nursing |
| Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the feasibility of a nursing support program intervention for work continuation in cancer patients undergoing outpatient treatment developed based on the theory of self-efficacy
Confirmation of the following: (1) Prospect of efficacy for a nursing support program intervention, (2) Completion of the study
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Self-efficacy scale scores
Key secondary outcomes
1) Number and percentage of patients who completed each intervention
2) Employment status (working hours and days)
3) Quality of life (QOL)
4) Psychological stress
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Individual consultations based on a nursing support program grounded in self-efficacy will be conducted by nurses.
Interventions/Control_2
Control group: receives standard outpatient care and nursing as usual
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Cancer patients who are continuing to work
2)Aged between 18 and 65 years old
3)Patients who have started outpatient treatment within the last 6 months
4)Patients with an ECOG Performance Status of 0 or 1
5)Patients who have provided written consent to participate in this study
6)Patients who are capable of verbal communication in Japanese
7)Patients whose physical and mental condition allows for a 60 minute interview, as determined by the attending physician and nurse
Key exclusion criteria
1)Individuals who will reach the mandatory retirement age during the study period
2)Individuals with cognitive impairments or other conditions that make verbal communication difficult
3)Patients scheduled for additional inpatient treatment, such as preoperative adjuvant therapy
4)Individuals whose condition has worsened due to cancer or other diseases, and whose prognosis is determined by the attending physician to be less than 6 months
5)Individuals deemed inappropriate by the principal investigator
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Masamitsu |
| Middle name | |
| Last name | Kobayashi |
Organization
Toho University
Division name
Faculty of Nursing
Zip code
143-0015
Address
5-21-16 Omorinishi, Ota-ku, Tokyo, Japan
TEL
03-3762-9236
masamitsu4k26@gmail.com
Public contact
Name of contact person
| 1st name | Masamitsu |
| Middle name | |
| Last name | Kobayashi |
Organization
Toho University
Division name
Faculty of Nursing
Zip code
143-0015
Address
5-21-16 Omorinishi, Ota-ku, Tokyo, Japan
TEL
03-3762-9236
Homepage URL
masamitsu4k26@gmail.com
Sponsor or person
Institute
Toho University
Institute
Department
Personal name
Funding Source
Organization
JSPS KAKENHI Grant Number 23K10015
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
Saint Lukes International University
Address
10-1 Akashi-cho, Chuo-ku, Tokyo, Japan
Tel
03-3543-6391
masamitsu4k26@gmail.com
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 | 10 | Month | 28 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 10 | Month | 28 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 22 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 10 | Month | 28 | Day |
Last modified on
| 2025 | Year | 11 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063922
