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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000018593
Receipt No. 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 2017/08/08

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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
Middle name
Last name Fumiko SATO
Organization Tohoku University Graduate School of Medicine
Division name Division of Oncology Nursing, Health Sciences
Zip code
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
Middle name
Last name Fumiko SATO
Organization Tohoku University Graduate School of Medicine
Division name Division of Oncology Nursing, Health Sciences
Zip code
Address 2-1 Seiryo-machi, aoba-ku,Sendai, Miyagi, Japan
TEL 022-717-7926
Homepage URL
Email fsato@med.tohoku.ac.jp

Sponsor
Institute Tohoku University Graduate School of Medicine
Institute
Department

Funding Source
Organization KAKEN
Organization
Division
Category of Funding Organization Other
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 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 No longer recruiting
Date of protocol fixation
2009 Year 11 Month 30 Day
Date of IRB
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
2017 Year 08 Month 08 Day


Link to view the page
URL(English) https://upload.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


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