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

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 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


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

Value
https://center6.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