UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000018593
Receipt number R000021516
Scientific Title The Perioperative Educational Program for Improving Upper Arm Dysfunction in Patients with Breast Cancer:A Prospective, Long-term, Controlled Trial
Date of disclosure of the study information 2015/08/07
Last modified on 2024/02/14 19:26:39

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Basic information

Public title

The Perioperative Educational Program for Improving Upper Arm Dysfunction in Patients with Breast Cancer:A Prospective, Long-term, Controlled Trial

Acronym

Improving Upper Arm Dysfunction in Breast Cancer

Scientific Title

The Perioperative Educational Program for Improving Upper Arm Dysfunction in Patients with Breast Cancer:A Prospective, Long-term, Controlled Trial

Scientific Title:Acronym

Improving Upper Arm Dysfunction in Breast Cancer

Region

Japan


Condition

Condition

Breast Cancer

Classification by specialty

Breast surgery Nursing

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To investigate the effectiveness of the perioperative educational program for improving upper arm dysfunction in breast cancer patients.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

shoulder range of motion, arm girth, grip strength
Outcome time:14 times of preoperation for 1 week for 1 month for 3 months 6 months later for every 6 months of 5 years after surgery.

Key secondary outcomes

Subjective Perception of Post-Operative Functional Impairment of the Arm(SPOFIA), Disabilities of the Arm,Shoulder and Hand(DASH), Medical Outcome Study 36-Item Short-Form Health Survey V2(SF-36v2), self care


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

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Pseudo-randomization


Intervention

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Behavior,custom

Interventions/Control_1

monitoring of arm function, exercises, massage, and lifestyle adjustments/standard routine care from the on-site staff
Intervention time:14 times of preoperation for 1 week after surgery for 1 month for 3 months 6 months later for every 6 months of 5 years follow-up.
Once approximately from 30 minutes to 1 hour.

Interventions/Control_2

standard routine care from the on-site staff

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

going to receive surgery, ECOG performance status 0-2, ability to respond to a self-administered questionnaire and no history of a diagnosis or treatment for mental illness, provided written informed consent

Key exclusion criteria

bilateral breast cancer, recurrence

Target sample size

66


Research contact person

Name of lead principal investigator

1st name Fumiko
Middle name
Last name SATO

Organization

Tohoku University Graduate School of Medicine

Division name

Division of Oncology Nursing, Health Sciences

Zip code

980-8575

Address

2-1 Seiryo-machi, aoba-ku,Sendai, Miyagi, Japan

TEL

022-717-7926

Email

fsato@med.tohoku.ac.jp


Public contact

Name of contact person

1st name Fumiko
Middle name
Last name Sato

Organization

Fukushima Medical University

Division name

School of Nursing

Zip code

960-1295

Address

1, Hikarigaoka, Fukushima City, Fukushima, 960-1295, Japan,

TEL

+81245471874

Homepage URL


Email

stfumiko@fmu.ac.jp


Sponsor or person

Institute

Tohoku University Graduate School of Medicine

Institute

Department

Personal name

Fumiko Sato


Funding Source

Organization

KAKEN

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Ethics Committee, Graduate School of Medicine, Tohoku University

Address

2-1 Seiryo-machi,Aoba-ku,Sendai, Miyagi 980-8575 Japan

Tel

+81-22-728-4105

Email

https://www.rinri.med.tohoku.ac.jp/portal/


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

東北大学病院(宮城県)


Other administrative information

Date of disclosure of the study information

2015 Year 08 Month 07 Day


Related information

URL releasing protocol


Publication of results

Partially published


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results

Prior to surgery the preoperative upper limb function was not significantly different between the intervention group and the control group. Upper arm circumference diameter in the intervention group The difference on the side of the affected side decreased on 5 years after surgery, but the control group increased significantly compared with 1 week after surgery. Shoulder joint flexion and abduction were significantly improved both in the intervention group (F = 28.9; p <.001) and in the control group (F = 13.9; p <.001) 5 years after surgery, but horizontal extension was intervention Only the group improved significantly (t = -2.09; p <.05). The SPOFIA score decreased significantly in the intervention group 5 years after surgery, but there was no significant difference in the control group. DASH significantly decreased in both groups in comparison between 1 week postoperatively and 5 years postoperatively. Interventional programs for prevention and improvement of upper limb dysfunction of breast cancer experienced persons up to 5 years after surgery suggested educational effect to improve upper limb swelling, shoulder joint movement range, and subjective symptoms of the arm.

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

Completed

Date of protocol fixation

2009 Year 11 Month 30 Day

Date of IRB

2009 Year 11 Month 30 Day

Anticipated trial start date

2010 Year 01 Month 13 Day

Last follow-up date

2017 Year 01 Month 26 Day

Date of closure to data entry

2017 Year 02 Month 01 Day

Date trial data considered complete

2017 Year 03 Month 01 Day

Date analysis concluded

2017 Year 03 Month 01 Day


Other

Other related information



Management information

Registered date

2015 Year 08 Month 07 Day

Last modified on

2024 Year 02 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021516


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name