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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000026212
Receipt No. R000030113
Scientific Title Monitoring Quality of Life in patients with breast cancer: the Care Notebook study
Date of disclosure of the study information 2017/02/19
Last modified on 2019/02/21

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Basic information
Public title Monitoring Quality of Life in patients with breast cancer: the Care Notebook study
Acronym Monitoring Quality of Life in patients with breast cancer: the Care Notebook study
Scientific Title Monitoring Quality of Life in patients with breast cancer: the Care Notebook study
Scientific Title:Acronym Monitoring Quality of Life in patients with breast cancer: the Care Notebook study
Region
Japan Europe

Condition
Condition breast cancer
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim of this randomized study is to investigate the effects of using routine QoL-assessments in daily oncology practice on aspects of medical care and patient outcomes.
Basic objectives2 Others
Basic objectives -Others The effects on patient management and length of the visit
Patients' perceived efficacy to communicate with healthcare providers
Patients' satisfaction regarding communication with their physician
Quality of Life and distress
Patients' perceptions of their illness
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase III

Assessment
Primary outcomes Mutual relations satisfaction of patients - medical provider
Key secondary outcomes The effects on patient management and length of the visit
Patients' perceived efficacy to communicate with healthcare providers
Patients' satisfaction regarding communication with their physician
Quality of Life and distress
Patients' perceptions of their illness
Validation and reliability

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification NO
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Care Notebook
Interventions/Control_2 non-Care Notebook
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)female patients who were histologically or pathologically confirmed as breast cance
2)patients with breast cancer to receive preoperation or postoperative chemotherapy
3)aged more than 20years
4)ECOG PS of 0-2
5)obtained written informed consent
Key exclusion criteria 1) patients that does receive chemotherapy before.
2) Doctor attending judged to be inappropriate in this study.
Target sample size 376

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kenichi Inoue
Organization Saitama Cancer Center
Division name Breast Oncology
Zip code
Address 780, Komuro, Ina-machi, Kita-Adachi-gun, Saitama, Japan
TEL 048-722-1111
Email ino@cancer-c.pref.saitama.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kenichi Inoue
Organization Saitama Cancer Center
Division name Breast Oncology
Zip code
Address 780, Komuro, Ina-machi, Kita-Adachi-gun, Saitama, Japan
TEL 048-722-1111
Homepage URL
Email ino@cancer-c.pref.saitama.jp

Sponsor
Institute Saitama Cancer Center
Institute
Department

Funding Source
Organization Saitama Cancer Center
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

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 埼玉県立がんセンター

Other administrative information
Date of disclosure of the study information
2017 Year 02 Month 19 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications https://link.springer.com/article/10.1007/s10549-017-4417-z
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 Enrolling by invitation
Date of protocol fixation
2014 Year 06 Month 04 Day
Date of IRB
Anticipated trial start date
2014 Year 07 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
2017 Year 02 Month 19 Day
Last modified on
2019 Year 02 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030113

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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