UMIN-CTR Clinical Trial

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
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	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041183