UMIN-CTR Clinical Trial

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

Breast cancer

Classification by specialty

Breast surgery

Classification by malignancy

Malignancy

Genomic information

NO

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

Primary outcomes

Patient satisfaction

Key secondary outcomes

Evaluation of deformation after breast conserving therapy

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

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

Institute

Department

Personal name

Organization

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

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2013

Year

03

Month

22

Day

URL releasing protocol

Publication of results

Unpublished

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

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 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

Registered date

2013

Year

03

Month

22

Day

Last modified on

2016

Year

09

Month

24

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012058