UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000007607
Receipt number R000008955
Scientific Title Longitudinal study for observing the process of informed consent for outpatient chemotherapy
Date of disclosure of the study information 2012/04/20
Last modified on 2014/02/27 11:36:02

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Basic information

Public title

Longitudinal study for observing the process of informed consent for outpatient chemotherapy

Acronym

Mixed methods Observational Research during Informed Consent process for outpatient chemotherapy (MORE-IC) Act2

Scientific Title

Longitudinal study for observing the process of informed consent for outpatient chemotherapy

Scientific Title:Acronym

Mixed methods Observational Research during Informed Consent process for outpatient chemotherapy (MORE-IC) Act2

Region

Japan


Condition

Condition

Lung Cancer, Breast Cancer

Classification by specialty

Pneumology Chest surgery Breast surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To demonstrate how the cancer patients continue receiving chemotherapy and maintain their motivation, this study employed mixed-method approach.

Basic objectives2

Others

Basic objectives -Others

Concrete aims:
1) examine the relationship among patient's concern about treatment, self-image, and subjective score for the process of informed consent,
2) conduct qualitative content analysis of the IC process, and describe how the physican-patient relationship emarge
3) reconfirm patient's interest about their treatment after the IC process,
4) quantify the patient's concern about treatment, and examine the change in their concern during chemotherapy,
5) make the data into longitudinal data set, and also process a cumulative case-study method.

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Questionnaire of Achievement Motive for Medical Treatment.
Subjective score for process of informed consent.

Key secondary outcomes

1) scales regarding self-image.
2) observation record during the IC process, including audio-taped and transcribed data.


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


Interventions/Control_2


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


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients are enrolled in the study if they meet all of the following criteria
1) Written informed consent.
2) They are 20 years old or older.
3) Patients who are eligible for the study by their physicians.

Key exclusion criteria

Patients who are disqualified the study by their physicians.

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yokode Masayuki

Organization

Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital

Division name

Clinical Inovative Medicine

Zip code


Address

54 Shogoin-Kawaharacho, Kyoto 606-8507 JAPAN

TEL

075-751-4743

Email

rinsho@kuhp.kyoto-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hatta Taichi

Organization

Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital

Division name

Clinical Inovative Medicine

Zip code


Address

54 Shogoin-Kawaharacho, Kyoto 606-8507 JAPAN

TEL

075-751-4739

Homepage URL

http://www.kuhp.kyoto-u.ac.jp/~rinsho/more-ic/index.html

Email

hatta1@kuhp.kyoto-u.ac.jp


Sponsor or person

Institute

Kyoto University Hospital

Institute

Department

Personal name



Funding Source

Organization

The Ministry of Education, Culture, Sports, Science, and Technology, Japan

Organization

Division

Category of Funding Organization

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

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

京都大学医学部附属病院(京都府)


Other administrative information

Date of disclosure of the study information

2012 Year 04 Month 20 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

2012 Year 02 Month 20 Day

Date of IRB


Anticipated trial start date

2012 Year 04 Month 01 Day

Last follow-up date

2013 Year 10 Month 01 Day

Date of closure to data entry

2013 Year 10 Month 01 Day

Date trial data considered complete

2013 Year 11 Month 01 Day

Date analysis concluded

2014 Year 03 Month 01 Day


Other

Other related information

Exploratory observing the process of the IC for outpatient chemotherapy, using both qualitative and quantitative approach.


Management information

Registered date

2012 Year 03 Month 29 Day

Last modified on

2014 Year 02 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008955


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name