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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000036145
Receipt No. 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 2019/09/23

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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
Hematology and clinical oncology Gastrointestinal surgery Urology
Nursing Adult
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To prevent side effects by intervention using interprofessional care protocol for eldery cancer patients
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Occurrence of side effects
Degree of side effects
Knowledge of side effects
Health Literacy
Self-care behavior
Medication adherence
Key secondary 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 40

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
Email 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
Email 17DN103@slcn.ac.jp

Sponsor
Institute St.Luke's International University
Institute
Department

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
Email 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
2020 Year 05 Month 30 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
2019 Year 09 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041183

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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