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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034527
Receipt No. R000039356
Scientific Title The effect of a comprehensive long-term rehabilitation care program to promote the life reconstruction of the breast cancer patients
Date of disclosure of the study information 2018/10/16
Last modified on 2018/10/16

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Basic information
Public title The effect of a comprehensive long-term rehabilitation care program to promote the life reconstruction of the breast cancer patients
Acronym The effect of breast cancer rehabilitation care program
Scientific Title The effect of a comprehensive long-term rehabilitation care program to promote the life reconstruction of the breast cancer patients
Scientific Title:Acronym The effect of breast cancer rehabilitation care program
Region
Japan

Condition
Condition breast cancer
Classification by specialty
Nursing
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Comprehensive rehabilitation care aimed at promoting living restructuring of breast cancer patients was carried out up to 3 years after operation and the effect of care was evaluated by randomized controlled trial with breast cancer specific QOL scale (FACT - B) as primary outcome
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes FACT-B (Functional Assessment of Cancer Therapy-Breast)
Outcomes are measured before surgery,and 3months,12months and 3 years after surgery
Key secondary outcomes Simplified Menopausal Index(SMI)
arm girth,shoulder ROM,and grip strength
Self-reported questionnaires,the Subjective Perception of Post-Operative Functional Impairment of the Arm(SPOFIA)
the Disabilities of the Arm,Shoulder and Hand(DASH)
Self-Care Agency Questionnaire(SCAQ)
body weight,LDL-C,HDL-C,Triglyceride

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 Comprehensive rehabilitation care program participation group
Interventions/Control_2 Postoperative upper limb dysfunction training program participation group
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
20 years-old >
Gender Female
Key inclusion criteria Women who undergo surgical therapy with primary breast cancer,Invitation Survey Registration at least 20 years old,No cognitive dysfunction,can be sent to a hospital,obtain the consent of participating in the research document.
Key exclusion criteria Can't communicate with cognitive dysfunction,can't speak Japanese,can't come to hospital.
Target sample size 46

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Fumiko Sato
Organization Health Sciences, Tohoku University Graduate School of Medicine
Division name Deperment of Oncology Nursing
Zip code
Address 2-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi 980-8575, Japan,
TEL +81-22-717-7926
Email fsato@med.tohoku.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Fumiko Sato
Organization Health Sciences, Tohoku University Graduate School of Medicine
Division name Deperment of Oncology Nursing
Zip code
Address 2-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi 980-8575, Japan
TEL +81-22-717-7926
Homepage URL
Email fsato@med.tohoku.ac.jp

Sponsor
Institute Tohoku University Graduate School of Medicin
Institute
Department

Funding Source
Organization the Japan Society for the Promotion of Science.
Organization
Division
Category of Funding Organization Japanese Governmental office
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
2018 Year 10 Month 16 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 Preinitiation
Date of protocol fixation
2018 Year 11 Month 26 Day
Date of IRB
Anticipated trial start date
2018 Year 11 Month 29 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 10 Month 16 Day
Last modified on
2018 Year 10 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039356

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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