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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000001108
Receipt No. 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

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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
Institute Nagoya City University
Institute
Department

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
URL(English) https://upload.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


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