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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000010303
Receipt No. R000012058
Scientific Title Research of Patient satisfaction after Breast conserving therapy
Date of disclosure of the study information 2013/03/22
Last modified on 2016/09/24

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Basic information
Public title Research of Patient satisfaction after Breast conserving therapy
Acronym Research of Patient satisfaction after Breast conserving therapy
Scientific Title Research of Patient satisfaction after Breast conserving therapy
Scientific Title:Acronym Research of Patient satisfaction after Breast conserving therapy
Region
Japan

Condition
Condition Breast cancer
Classification by specialty
Breast surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To clarify the extent of preserved breast deformation and differences in patient satisfaction and investigate the clinical factors affecting breast deformation.
Basic objectives2 Others
Basic objectives -Others To clarify the extent of preserved breast deformation and differences in patient satisfaction and investigate the clinical factors affecting breast deformation.
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Patient satisfaction
Key secondary outcomes Evaluation of deformation after breast conserving therapy

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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

Not applicable
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria Patients scheduled for outpatient follow-up examination at one, two, and three years after undergoing breast-conserving therapy at the Cancer Institute Hospital of JFCR were enrolled.
Key exclusion criteria Patients less than one year after surgery.
Cases of bilateral breast cancer.
Cases of ipsilateral metachronous breast cancer.
Cases of local recurrence and distant recurrence.
The cases which are included past surgical wound in the shooting range.
Cases of bilateral breast cancer.
Patients who underwent mastectomy after breast-conserving surgery.
Target sample size 230

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshinari Goto
Organization Cancer Institute Hospital, Japanese Foundation for Cancer Research
Division name Breast Oncology Center
Zip code
Address 3-8-31, Ariake, Koto-ku, Tokyo, 135-8550 Japan
TEL 03-3520-0111
Email yoshinari510@mail.goo.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshinari Goto
Organization Cancer Institute Hospital, Japanese Foundation for Cancer Research
Division name Breast Oncology Center
Zip code
Address 3-8-31, Ariake, Koto-ku, Tokyo, 135-8550 Japan
TEL 03-3520-0111
Homepage URL
Email yoshinari510@mail.goo.ne.jp

Sponsor
Institute Cancer Institute Hospital, Japanese Foundation for Cancer Research. Breast Oncology Center
Institute
Department

Funding Source
Organization Cancer Institute Hospital, Japanese Foundation for Cancer Research. Breast Oncology Center
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information
2013 Year 03 Month 22 Day

Related information
URL releasing protocol
Publication of results Unpublished

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 No longer recruiting
Date of protocol fixation
2013 Year 01 Month 15 Day
Date of IRB
Anticipated trial start date
2013 Year 03 Month 22 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Patient satisfaction was assessed on the basis of the following four levels of satisfaction:
1. Satisfied
2. Somewhat satisfied
3. Somewhat unsatisfied
4. Unsatisfied

We evaluated each of the following items while assessing satisfaction and cosmetic appearance:

Age
disease location
Resection volume (weight)
Whether or not radiotherapy was administered
Whether or not chemotherapy was administered
Whether or not hormone therapy was administered
Disease stage

Cosmetic appearance was scored on the basis of the following parameters that conformed to the evaluation of postoperative cosmetic outcome by the Japanese Breast Cancer Society Sawai group:
1. Breast size: 2 (almost identical), 1 (minor difference), and 0 (considerable difference)
2. Breast shape: 2 (almost identical), 1 (minor difference), and 0 (considerable difference)
3. Scar: 2 (Unnoticeable) and 1 (slightly noticeable)
4. Breast firmness: 2 (soft), 1 (somewhat firm), and 0 (fairly firm)
5. Nipple and areola size/shape: 1 (no difference between left and right) and 0 (difference between left and right)
6. Nipple and areola color tone: 1 (no difference between left and right) and 0 (difference between left and right)
7. Nipple position (difference between left and right with regard to distance from sternal incisures): 1 (<2 cm) and 0 (greater than or equal to 2 cm)
8. Position of the maximum descent point of the breast (difference in height between left and right): 1 (<2 cm) and 0 (greater than or equal to 2 cm)
9. Comprehensive evaluation: 11-12 points, excellent; 8-10 points, good; 5-7 points, fair; and 0-4 points, poor

Management information
Registered date
2013 Year 03 Month 22 Day
Last modified on
2016 Year 09 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012058

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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