UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Research of Patient satisfaction after Breast conserving therapy
Title of the study (Brief title)	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	Yoshinari Goto
Organization	Cancer Institute Hospital, Japanese Foundation for Cancer Research
Division name	Breast Oncology Center
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	Yoshinari Goto
Organization	Cancer Institute Hospital, Japanese Foundation for Cancer Research
Division name	Breast Oncology Center
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)

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

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2013 Year 01 Month 15 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000012058