UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036145 |
|---|---|
| Receipt number | R000041183 |
| Scientific Title | Implementation of an Interprofessional Outpatient Support Protocol to Prevent Oral Chemotherapy Side Effects in Elderly Cancer Patients |
| Date of disclosure of the study information | 2019/03/10 |
| Last modified on | 2022/03/17 01:30:09 |
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Basic information
Public title
Implementation of an Interprofessional Outpatient Support Protocol
to Prevent Oral Chemotherapy Side Effects in Elderly Cancer Patients
Acronym
Implementation Study to Prevent Oral Chemotherapy Side Effects in Elderly Cancer Patients
Scientific Title
Implementation of an Interprofessional Outpatient Support Protocol
to Prevent Oral Chemotherapy Side Effects in Elderly Cancer Patients
Scientific Title:Acronym
Implementation Study to Prevent Oral Chemotherapy Side Effects in Elderly Cancer Patients
Region
| Japan |
Condition
Condition
Gastrointestinal Cancer
Urological Cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine | Gastrointestinal surgery | Urology |
| Nursing | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of intervention using protocol
Basic objectives2
Others
Basic objectives -Others
Evaluation of the implementation strategy
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Knowledge of side effects
Occurrence of side effects
Degree of side effects
Health Literacy
Self-care behavior
Medication adherence
Key secondary outcomes
Implementation outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Intervention consisting of 4STEP based on interprofessional care protocol to prevent side effects of the elderly
STEP 1 Screening of high-risk patients using G8 and CARG scores
STEP 2 Teaching according to characteristics of the elderly
STEP 3 Information sharing among multiple occupations by recording system
STEP 4 Cooperation with caregiver and community
Interventions/Control_2
At the timing of outpatient visit, we intervene three times for a total of three months
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
| 65 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Patient over 65 years old.
2.Patient who starts outpatient treatment with tegafur / gimeracil / oteracil potassium or sunitinib
Key exclusion criteria
1.Patients with dementia or declining cognitive function
2.Patients who have a heavy burden on body and psychology by intervention
3.Patients with combination therapy
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Miki |
| Middle name | |
| Last name | Koyama |
Organization
St.Luke's International University
Division name
Doctoral course of Nursing (DNP course)
Zip code
104-0044
Address
10-1, Akashicho, Chuo-ku, Tokyo, 104-0044, Japan
TEL
0333538111
17DN103@slcn.ac.jp
Public contact
Name of contact person
| 1st name | Miki |
| Middle name | |
| Last name | Koyama |
Organization
St.Luke's International University
Division name
Doctoral course of Nursing (DNP course)
Zip code
104-0044
Address
10-1, Akashicho, Chuo-ku, Tokyo, 104-0044, Japan
TEL
0333538111
Homepage URL
17DN103@slcn.ac.jp
Sponsor or person
Institute
St.Luke's International University
Institute
Department
Personal name
Funding Source
Organization
Foundation for Promotion of Cancer Research
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
St.Luke's International University Research Ethics Committee
Address
10-1, Akashicho, Chuo-ku, Tokyo, 104-0044, Japan
Tel
03-5550-2423
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
東京女子医科大学病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 03 | Month | 10 | 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
| 2019 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 28 | Day |
Anticipated trial start date
| 2019 | Year | 08 | Month | 30 | Day |
Last follow-up date
| 2023 | Year | 03 | 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
| 2019 | Year | 03 | Month | 10 | Day |
Last modified on
| 2022 | Year | 03 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041183
