UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028619 |
|---|---|
| Receipt number | R000032753 |
| Scientific Title | Evaluation research on nursing support algorithm for harmonization of social role and treatment of cancer survivor |
| Date of disclosure of the study information | 2017/08/25 |
| Last modified on | 2022/08/16 15:28:48 |
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Basic information
Public title
Evaluation research on nursing support algorithm for harmonization of social role and treatment of cancer survivor
Acronym
Evaluation of nursing support algorithm for harmony between social role and treatment
Scientific Title
Evaluation research on nursing support algorithm for harmonization of social role and treatment of cancer survivor
Scientific Title:Acronym
Evaluation of nursing support algorithm for harmony between social role and treatment
Region
| Japan |
Condition
Condition
Cancer patients undergoing external chemotherapy / radiotherapy, care provided nurse
Classification by specialty
| Nursing | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Nursing support by nurses involved in outpatient cancer treatment and support by nursing algorithms for harmonizing social roles and treatments (hereinafter referred to as "nursing algorithm support") are continuing social roles of patients,assistance of nurses/Behavior)is different
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Nurse: Evaluation of nursing support for social role to target and Patient data: thermometers and troublesome thermometers and turnover rates
Key secondary outcomes
* Improve recognition of social role support
* Improve the quality of outpatient nursing
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Pseudo-randomization
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Algorithm support / regular care
Supporters support and support nursing algorithms that harmonize social roles and treatments. These can help support the situation of the roles of families, workers and local communities and the side effect management by treatment smoothly. Meanwhile, in the control group, care normally undertaken is carried out. Each for two months from before treatment
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Outpatient chemotherapy center
Nurse working in outpatient department and patients who receive chemotherapy treatment and radiation therapy from the first time and those who care
Key exclusion criteria
Patient: Person who can not express his / her intention, palliative radiotherapy practitioner
Nurse: Person who is difficult to respond to interview
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Kiyoko |
| Middle name | |
| Last name | Kanda |
Organization
Gunma University Graduate School of Health Sciences
Division name
Department of Nursing
Zip code
371-8514
Address
3-39-22,Showa-machi Maebashi Gunma
TEL
027-220-8929
kkanda@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | Kanda |
| Middle name | |
| Last name | Kiyoko |
Organization
Gunma University Graduate School of Health Sciences
Division name
Department of Nursing
Zip code
371-8514
Address
3-39-22,Showa-machi Maebashi Gunma
TEL
027-220-8929
Homepage URL
kkanda@gunma-u.ac.jp
Sponsor or person
Institute
Takasaki University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
MEXT(Japan)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
MEXT JSPS KAKENHI Grant-in-Aid
Other related organizations
Co-sponsor
Takasaki University of Health and Welfare,Department of Nursing
Gunma Prefectural College of Health Sciences, Department of Nursing
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Gunma University
Address
Gunma Showa machi, Maebashi-city3-39-15
Tel
0272208929
kkanda@gunma-u.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
群馬大学医学部附属病院（群馬県）
日高病院（群馬県）、藤岡総合病院（群馬県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 08 | Month | 25 | Day |
Related information
URL releasing protocol
Cancer Nursing: April 9, 2022 - Volume - Issue - 10.1097/NCC.0000000000001108 doi: 10.1097/NCC.00000
Publication of results
Published
Result
URL related to results and publications
Cancer Nursing: April 9, 2022 - Volume - Issue - 10.1097/NCC.0000000000001108 doi: 10.1097/NCC.00000
Number of participants that the trial has enrolled
108
Results
DIT scores in the intervention group were significantly lower than those in the control group.2 months later 20 participants had resigned from their employment or were on leave in the control group (37.0%); this was twice the number in the intervention group, confirming a significant difference. Logistic regression analysis showed that the odds ratio in the control group was 3.6 times than that of the intervention group.The ANI appears to have prevented resignations 2 months after implementation.
Results date posted
| 2022 | Year | 08 | Month | 16 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2022 | Year | 04 | Month | 09 | Day |
Baseline Characteristics
The ages of the participants in the control group ranged from 45 to 81 years(mean 62.6), and those in the intervention group ranged from 33 to 79 years (mean 61.0). The mean ages of the groups did not differ significantly. Participants in the intervention and control groups were selected to match cancer setting, stage, PS, and treatment at sampling and the results were also similar. There were no significant difference in attributes between groups prior to the intervention.
Participant flow
In total,149 patients were invited to participate in the study and received written and verbal explanations of the study. Of these, 130 agreed to participate in the study. Randomization was performed at each facility, with 66 participants assigned to standard nursing support (control group), and 64 to the ANI (intervention group) (Figure 1). Study participants agreed to participate for two months. However, certain participants did not complete the study period for the following reasons: 1) declined to participate after the second time (n=6), 2) declined due to strong side-effects (n=2:), treatment or hospital change (n=3), and hospitalization (n=1), and 3) declined further treatment (n=2). The reason for 2) declined due to strong side-effects was only the intervention group, but otherwise there was no difference between the two groups. Nine participants were excluded from the analysis due to inadequate data. Data from 54 participants in each group were analyzed.
Adverse events
Strong side effects of the drug (n=2:)
Outcome measures
(1) Distress and Impact Thermometer (DIT)
(2) The number of adverse events
(3) Presence/absence of social roles
(4) Changes in employment
(5) Interprofessional collaboration
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2017 | Year | 08 | Month | 04 | Day |
Date of IRB
| 2017 | Year | 08 | Month | 03 | Day |
Anticipated trial start date
| 2017 | Year | 08 | Month | 20 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 06 | Month | 01 | Day |
Date analysis concluded
| 2020 | Year | 10 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 08 | Month | 09 | Day |
Last modified on
| 2022 | Year | 08 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032753
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