UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022359
Receipt number R000025761
Scientific Title Development of the nursing support program in the decision making of the medical treatment policy of cancer patients receiving chemotherapy
Date of disclosure of the study information 2016/05/19
Last modified on 2016/09/13 14:31:45

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Basic information

Public title

Development of the nursing support program in the decision making of the medical treatment policy of cancer patients receiving chemotherapy

Acronym

Development of the nursing support program in the decision making of the medical treatment policy of cancer patients receiving chemotherapy

Scientific Title

Development of the nursing support program in the decision making of the medical treatment policy of cancer patients receiving chemotherapy

Scientific Title:Acronym

Development of the nursing support program in the decision making of the medical treatment policy of cancer patients receiving chemotherapy

Region

Japan


Condition

Condition

advanced cancer

Classification by specialty

Nursing

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Development of the nursing support program to promote the proactive decision of advanced cancer patients receiving chemotherapy in a medical treatment policy based on a wish and sense of values

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Decision Conflict Scale

Key secondary outcomes

State-Trait Anxiety Inventory
Brief Cancer-related Worry
Self-efficacy scale for advanced cancer


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

I support it in an interview form in front and behind an informed consent
It's composed of 1 program by 3 times of interview, and 1 program for 3 months is performed total of 3 times

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

A disease name, a diagnosis of recurrence and a metastasis, the treatment purpose and possibility of the therapeutic effect are explained
At the time to consider effect measurement of chemotherapy and medicine change.
A doctor judges that there is ability of the decision making
Consent is got by this research

Key exclusion criteria

Communication is difficult in Japanese
The patient of the mind and body state who can't stand interview
Performance Status is more than 3

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Akiko Honda

Organization

Tokyo Medical and Dental University

Division name

graduate school of health care sciences

Zip code


Address

1-5-45 Bunkyou-ku Yushima, Tokyo

TEL

03-5803-5355

Email

akikchn@tmd.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yuka Ishihara

Organization

Tokyo Medical and Dental University

Division name

graduate school of health care sciences

Zip code


Address

1-5-45 Bunkyou-ku Yushima, Tokyo

TEL

03-3813-6111

Homepage URL


Email

yishihara.chn@tmd.ac.jp


Sponsor or person

Institute

Tokyo Medical and Dental University

Institute

Department

Personal name



Funding Source

Organization

No

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



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



Other administrative information

Date of disclosure of the study information

2016 Year 05 Month 19 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

Terminated

Date of protocol fixation

2016 Year 07 Month 26 Day

Date of IRB


Anticipated trial start date

2016 Year 08 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 05 Month 19 Day

Last modified on

2016 Year 09 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025761


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name