UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000001108
Receipt number R000001341
Scientific Title Feasibility study of intervention based care needs of breast cancer patients receiving adjuvant therapy
Date of disclosure of the study information 2008/04/03
Last modified on 2017/06/22 20:25:48

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Basic information

Public title

Feasibility study of intervention based care needs of breast cancer patients receiving adjuvant therapy

Acronym

Feasibility study of intervention based care needs of breast cancer patients receiving adjuvant therapy

Scientific Title

Feasibility study of intervention based care needs of breast cancer patients receiving adjuvant therapy

Scientific Title:Acronym

Feasibility study of intervention based care needs of breast cancer patients receiving adjuvant therapy

Region

Japan


Condition

Condition

Breast cancer patients receiving postoperative adjuvant therapy

Classification by specialty

Breast surgery Psychiatry Nursing

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To assess the feasibility of comprehensive intervention based individual care needs with breast cancer patients experiencing psychosocial distress, and to identify the effectiveness of the intervention program for them preliminarily

Basic objectives2

Others

Basic objectives -Others

Feasibility/effectiveness

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase



Assessment

Primary outcomes

Profile of Mood States (POMS)

Key secondary outcomes

1.The short-form Supportive Care Needs Survey (SCNS-SF34)
2.European Organization for Research and Treatment of Cancer QLQ-C30(EORTC QLQC-30)
3.The Concerns About Recurrence Scale (CARS)
4.Patient Satisfaction


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

Educational,Counseling,Training

Type of intervention

Behavior,custom

Interventions/Control_1

1.Patient's care needs identification
2.Brief Problem-Solving Therapy (4 sessions during 2 months)
3.Information giving
4.Care coordination

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

Female

Key inclusion criteria

1.Being identified invasive ductal carcinoma of the breast histologically
2.Having no distant metastasis
3.Being 3 months or more and less than six months from the surgery
4.Receiving a score of 0 to 2 on the European Organization for Research and Treatment of Cancer-Performance Status (ECOG-PS)
5.Being 20 years of age or older
6.Meeting the screening criteria for psychological distress

Key exclusion criteria

1.too physically and mentally ill to complete a self-reported questionnaire and the intervention
2.Having cognitive impairment
3.Being unable to read and write Japanese
4.Being Considered by the oncologist to be unable to participate the study

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Tatsuo Akechi

Organization

Nagoya City University Medical School

Division name

Department of Psychiatry

Zip code


Address

Kawasumi 1, mizuho-cho, mizuho-ku, Nagoya 467-8601

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name Kanae Momino

Organization

Nagoya City University

Division name

School of Nursing

Zip code


Address

Kawasumi 1, mizuho-cho, mizuho-ku, Nagoya 467-8601

TEL


Homepage URL


Email

momino@med.nagoya-cu.ac.jp


Sponsor or person

Institute

Nagoya City University

Institute

Department

Personal name



Funding Source

Organization

Ministry of Health, Labour and Welfare

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor

None

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

2008 Year 04 Month 03 Day


Related information

URL releasing protocol


Publication of results

Published


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

Main results already published

Date of protocol fixation

2007 Year 08 Month 31 Day

Date of IRB


Anticipated trial start date

2008 Year 04 Month 01 Day

Last follow-up date

2010 Year 10 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2008 Year 04 Month 03 Day

Last modified on

2017 Year 06 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001341


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name