UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004053
Receipt number R000004885
Scientific Title Cancer functional assessment set(CFAS):a new tool for measurement of physical function in patients with cancer.
Date of disclosure of the study information 2010/08/17
Last modified on 2014/02/22 17:30:52

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Basic information

Public title

Cancer functional assessment set(CFAS):a new tool for measurement of physical function in patients with cancer.

Acronym

Cancer functional assessment set(CFAS):a new tool

Scientific Title

Cancer functional assessment set(CFAS):a new tool for measurement of physical function in patients with cancer.

Scientific Title:Acronym

Cancer functional assessment set(CFAS):a new tool

Region

Japan


Condition

Condition

Inpatient with cancer

Classification by specialty

Rehabilitation medicine

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To develop a new tool for measurement of physical function in patients with cancer

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

range of motion, muscle strength ,body flexibility, sensory, upper limb function, balance function, basic activity, physical activity

Key secondary outcomes

cognitive function, locomotion, consciousness level (Glasgow Come Scale), physical symptom (pain, nausea, dyspnea, fatigue), Performance status of ECOG (PS), Karnofsky performance Status (KPS), Functional independence measure (FIM)


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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Inpatients receiving treatment for cancer and rehabilitation (physical therapy and/or occupational therapy and/or speech therapy) in Keio university hospital.

Key exclusion criteria

1. Patients who have difficulty with communication.
2. Patients receiving rehabilitation of deficit which is not related to cancer itself or the treatment of it.
3. Patients receiving only speech therapy.
4. Patients receiving preventive rehabilitation, perioperative rehabilitation, and treatment of lymphedema.
5. Other various conditions in which the attending doctor decides not suitable for entry.

Target sample size

60


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Tsuji Tetsuya

Organization

Keio University

Division name

School of Medicine,Dep.of Rehabilitation Medicine

Zip code


Address

Shinanomachi 35,Shinjyuku-ku,Tokyo,Japan.

TEL

03-5363-3833

Email

cxa01423@nifty.com


Public contact

Name of contact person

1st name
Middle name
Last name Miyata Chieko

Organization

Keio University

Division name

School of Medicine,Dep.of Rehabilitation Medicine

Zip code


Address

Shinanomachi 35,Shinjyuku-ku,Tokyo,Japan.

TEL

03-5363-3833

Homepage URL


Email

kuma1mie2chibi3@yahoo.co.jp


Sponsor or person

Institute

Keio University

Institute

Department

Personal name



Funding Source

Organization

none

Organization

Division

Category of Funding Organization

Self funding

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

慶應義塾大学病院(東京都)


Other administrative information

Date of disclosure of the study information

2010 Year 08 Month 17 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

The cFAS consisted of 24 items. The cFAS consisted of 24 items. Significant correlations were found between the cFAS and existing scales. Cronbach's alpha for the total score was 0.92. Weighted kappa values for each item ranged from 0.74 to 1.00. The intra-class correlation for the total score was 0.97.The cFAS was more responsive to changes than the other tools. The cFAS has acceptable psychometric properties. It can be a useful tool in clinical trials and contribute to the development of cancer rehabilitation.

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

2010 Year 06 Month 01 Day

Date of IRB


Anticipated trial start date

2010 Year 08 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2013 Year 02 Month 20 Day


Other

Other related information

We evaluate physical functions, physical symptoms, Performance status of ECOG (PS), Karnofsky performance Status (KPS), Functional independence measure (FIM) before and after rehabilitation, and analyze their psychological characteristics.


Management information

Registered date

2010 Year 08 Month 17 Day

Last modified on

2014 Year 02 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004885


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name