UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025671
Receipt number R000029481
Scientific Title Nursing interventions for family caregiver of primary brain tumor patient, encouraging how to cope with life changes
Date of disclosure of the study information 2017/01/17
Last modified on 2017/08/25 16:58:42

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Nursing interventions for family caregiver of primary brain tumor patient, encouraging how to cope with life changes

Acronym

Nursing interventions for family caregiver of primary brain tumor patient, encouraging how to cope with life changes

Scientific Title

Nursing interventions for family caregiver of primary brain tumor patient, encouraging how to cope with life changes

Scientific Title:Acronym

Nursing interventions for family caregiver of primary brain tumor patient, encouraging how to cope with life changes

Region

Japan


Condition

Condition

family caregiver of primary malignant brain tumor patient

Classification by specialty

Nursing Adult

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate Nursing intervention ,from the point of coping,QOL,burden

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Caregiver:
1)Coping
2)QOL
3)Burden

Key secondary outcomes



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

1)Nursing assessment at least once a month
2)Nursing care based on the nursing assessment

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

1) Main family caregiver of primary brain tumor.
2) Patient who has the recurrence and neurological symptoms and/or brain dysfunctions. Or patient who has high possibility of recurrence and will have neurological symptoms and/or brain dysfunctions.
3) Patient and family caregiver who know patient's cancer diagnosis.
4) Patient and family caregiver who can communicate in Japanese.

Key exclusion criteria

1)family caregiver who has mental problems

Target sample size

8


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hitomi Sato

Organization

Chiba university

Division name

Graduate school of Nursing

Zip code


Address

1-8-1 Inohana, Chuo-ku, Chiba 260-8672 JAPAN

TEL

043-222-7171

Email

hsato@chiba-u.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hitomi Sato

Organization

Chiba university

Division name

Graduate school of Nursing

Zip code


Address

1-8-1 Inohana, Chuo-ku, Chiba 260-8672 JAPAN

TEL

043-222-7171

Homepage URL


Email

hsato@chiba-u.jp


Sponsor or person

Institute

Chiba university

Institute

Department

Personal name



Funding Source

Organization

None

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

2017 Year 01 Month 17 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

2016 Year 12 Month 09 Day

Date of IRB


Anticipated trial start date

2017 Year 01 Month 06 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

2017 Year 01 Month 14 Day

Last modified on

2017 Year 08 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029481


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name