UMIN-CTR Clinical Trial

Basic information
Public title	Effects of a Patient-Centered Medication Self-Management Support Program for Cancer Patients: a Mixed-Method Study
Acronym	Effects of a Medication Self-Management Support Program for Cancer Patients
Scientific Title	Effects of a Patient-Centered Medication Self-Management Support Program for Cancer Patients: a Mixed-Method Study
Scientific Title:Acronym	Effects of a Medication Self-Management Support Program for Cancer Patients
Region	Japan

Condition
Condition	Breast Cancer
Classification by specialty	Hematology and clinical oncology Breast surgery Nursing
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To assess the effects of a Patient-Centred Medication Self-Management Support Programme in patients receiving oral anticancer treatment, and to understand how the programme does or does not work from perceptions of intervention nurses.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Adherence to medication(:medication procession ratio (MPR)
Key secondary outcomes	:Self-efficacy, Quality of life, Psychological distress, Symptoms severity and interference, Patient satisfaction, Emergency department visits, and hospital admissions.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation
Institution consideration
Blocking
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Other
Interventions/Control_1	We developed the Patient-Centred Medication Self-Management Support Programme consisting of three elements: information-giving using teach back, patient preference, and follow-up by nurse under the concept of concordance and shared decision making. In addition to the usual care, the intervention group will receive two sessions of the Patient-Centred Medication Self-Management Support Programme delivered by trained nurses in clinic at one month and two months. Each session will take 20 to 30 minutes.
Interventions/Control_2	Control groups will receive usual care.
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	90 years-old >
Gender	Male and Female
Key inclusion criteria	They are:(1) 20-89 years of age, (2) patients with metastatic breast cancer, (3) able to complete to the questionnaire in Japanese, (4) newly prescribed oral chemotherapy or target therapy medication, (5) able to manage medication without any assistance, or (6) having prognosis of more than three months determined by the primary physician.
Key exclusion criteria	They (1) have cognitive impairment or mental disorders, (2) have brain metastasis, (3) receive infusion therapy, and (4) are participants in another study.
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Middle name Last name Hiroko Komatsu
Organization	Keio University
Division name	Faculty of Nursing and Medical Care
Zip code
Address	35 Shinanomachi, Shinjukuku, Tokyo 1608582, Japan
TEL	03-5363-3733
Email	komah@sfc.keio.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Kaori Yagasaki
Organization	Keio University
Division name	Faculty of Nursing and Medical Care
Zip code
Address	35 Shinanomachi, Shinjukuku, Tokyo 1608582, Japan
TEL	03-5363-2157
Homepage URL
Email	yagasaki@sfc.keio.ac.jp

Sponsor
Institute	Keio University, Faculty of Nursing and Medical Care
Institute
Department

Funding Source
Organization	Grant-in-Aid for scientific research(A)
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs	YES
Study ID_1	2014-267
Org. issuing International ID_1	National Cancer Center
Study ID_2	26ken-29
Org. issuing International ID_2	Kanagawa Cancer Center
IND to MHLW

Institutions
Institutions	国立がん研究センター中央病院（東京都）、国立がん研究センター東病院（千葉県）、神奈川県立がんセンター（神奈川県）,昭和大学病院（東京都）

Other administrative information
Date of disclosure of the study information	2015 Year 02 Month 27 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	Completed
Date of protocol fixation	2015 Year 02 Month 13 Day
Date of IRB	2014 Year 11 Month 25 Day
Anticipated trial start date	2015 Year 03 Month 16 Day
Last follow-up date	2018 Year 07 Month 20 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2015 Year 02 Month 21 Day
Last modified on	2020 Year 06 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019226