UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011190
Receipt number R000013112
Scientific Title Problem-solving therapy for breast cancer patients undergoing chemotherapy on an outpatient basis
Date of disclosure of the study information 2013/09/01
Last modified on 2014/01/16 17:49:20

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Basic information

Public title

Problem-solving therapy for breast cancer patients undergoing chemotherapy on an outpatient basis

Acronym

Problem-solving therapy for breast cancer patients

Scientific Title

Problem-solving therapy for breast cancer patients undergoing chemotherapy on an outpatient basis

Scientific Title:Acronym

Problem-solving therapy for breast cancer patients

Region

Japan


Condition

Condition

Breast cancer

Classification by specialty

Medicine in general Hematology and clinical oncology Psychosomatic Internal Medicine
Breast surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the effectiveness of problem-solving therapy on quality of life in breast cancer patients undergoing chemotherapy

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Phase II


Assessment

Primary outcomes

Quality of Life (EORTC-QLQ C30, BR23)

Key secondary outcomes

Care Note, Euro Qol (EQ-5D), Quality-adjusted life years (QALYs),
Global Rating of Change Questionnaires, Hospital Anxiety and Depression Scale (HADS), Brief Coping Orientation to Problems Experienced (COPE)


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

NO

Dynamic allocation

YES

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Behavior,custom

Interventions/Control_1

No intervention (standard chemotherapy only)

Interventions/Control_2

Problem-solving therapy

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

Female

Key inclusion criteria

1) Pathologically confirmed invasive breast cancer
2) Undergoing chemotherapy on an outpatient basis
3) General condition is good enough to participate in this study.
4) Subjects who can read Japanese and complete self-report questionnaires

Key exclusion criteria

1) History of other malignancy except for curatively treated carcinoma
2) Severe cognitive dysfunction
3) Severe psychiatric disorder

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Toshimi Takano

Organization

Toranomon Hospital

Division name

Department of Medical Oncology

Zip code


Address

2-2-2 Toranomon, Minato-ku, Tokyo 105-8470, Japan

TEL

03-3588-1111

Email

takano@toranomon.gr.jp


Public contact

Name of contact person

1st name
Middle name
Last name Toshimi Takano

Organization

Toranomon Hospital

Division name

Department of Medical Oncology

Zip code


Address

2-2-2 Toranomon, Minato-ku, Tokyo 105-8470, Japan

TEL

03-3588-1111

Homepage URL


Email

takano@toranomon.gr.jp


Sponsor or person

Institute

Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

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

虎の門病院(東京都)


Other administrative information

Date of disclosure of the study information

2013 Year 09 Month 01 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

2013 Year 07 Month 08 Day

Date of IRB


Anticipated trial start date

2013 Year 09 Month 01 Day

Last follow-up date


Date of closure to data entry

2013 Year 12 Month 31 Day

Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2013 Year 07 Month 15 Day

Last modified on

2014 Year 01 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013112


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name