UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016597 |
|---|---|
| Receipt number | 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 | 2020/06/15 08:33:46 |
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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
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
yagasaki@sfc.keio.ac.jp
Sponsor or person
Institute
Keio University, Faculty of Nursing and Medical Care
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019226
