UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Monitoring Quality of Life in patients with breast cancer: the Care Notebook study
Title of the study (Brief title)	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	Kenichi Inoue
Organization	Saitama Cancer Center
Division name	Breast Oncology
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	Kenichi Inoue
Organization	Saitama Cancer Center
Division name	Breast Oncology
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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2014 Year 06 Month 04 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results	https://link.springer.com/article/10.1007/s10549-017-4417-z
Results
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/icdr_e/ctr_view.cgi?recptno=R000030113