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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000016597
Receipt No. R000019226
Scientific Title Effects of a Patient-Centered Medication Self-Management Support Program for Cancer Patients: a Mixed-Method Study
Date of disclosure of the study information 2015/02/27
Last modified on 2018/08/25

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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 No longer recruiting
Date of protocol fixation
2015 Year 02 Month 13 Day
Date of IRB
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
2018 Year 08 Month 25 Day


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

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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