UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026212 |
|---|---|
| Receipt number | 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 17:39:09 |
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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
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
ino@cancer-c.pref.saitama.jp
Sponsor or person
Institute
Saitama Cancer Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030113
