UMIN-CTR Clinical Trial

Public title

Effects of education and speed-feedback therapy on cancer and cancer treatment-related cognitive changes in patients with breast cancer

Acronym

Effects of education and speed-feedback therapy on cancer and cancer treatment-related cognitive changes in patients with breast cancer

Scientific Title

Effects of education and speed-feedback therapy on cancer and cancer treatment-related cognitive changes in patients with breast cancer

Scientific Title:Acronym

Effects of education and speed-feedback therapy on cancer and cancer treatment-related cognitive changes in patients with breast cancer

Region

Japan

Condition

Breast cancer

Classification by specialty

Nursing

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

The purpose of this study is to evaluate the effects of education and speed-feedback therapy on cancer and cancer treatment-related cognitive changes in breast cancer patients who have received chemotherapy and are receiving hormonal therapy for breast cancer.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

Differences in the mean score changes of the Functional Assessment of Cancer Therapy-Cognitive Function Version 3 (FACT-Cog)
Time of data collection: baseline, after two weeks, after four weeks (the end of the intervention)

Key secondary outcomes

Differences in the mean score changes of the Functional Assessment of Cancer Therapy-General version4 (FACT-G)
Time of data collection: baseline, after two weeks, after four weeks (the end of the intervention)

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No need to know

No. of arms

3

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Maneuver

Interventions/Control_1

Speed-feedback therapy: Training with the machine which is a bicycle ergometer connected with a personal computer.
Duration: 4 weeks
Amount: The exercise load at 20 W, and 5 min per one exercise
Frequency: one exercise per one week

Interventions/Control_2

Education: Explain about cancer and cancer therapy-related cognitive impairments; "What is a cognitive function", "Influence of cancer and cancer therapy on cognitive function", "Strategies to improve cognitive function", "Coping strategies for cognitive changes".
Frequency: one time

Interventions/Control_3

Regular care: Receiving regular care in patients' usual lifestyle.

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

65

years-old

>

Gender

Female

Key inclusion criteria

Breast cancer patients who are:
1) received chemotherapy for breast cancer within ten years
2) receiving hormonal therapy
3) aware of their cognitive changes (deteriorate of memory, deteriorate of concentration, or deteriorate of executive function, etc.)
4) evaluated as more than 24 points with MMSE (Mini-Mental State Examination)
5) estimated as 0 or 1 Performance Status

Key exclusion criteria

Breast cancer patients who are:
1) with metastasis
2) experience of whole brain irradiation
3) with trouble in mental health
4) with heart or respiratory disease to need risk management
5) not able to use a bicycle because of orthopedics disease or central nerve paralysis

Target sample size

111

Name of lead principal investigator

1st name
Middle name
Last name	Mika Miyashita

Organization

Hiroshima University

Division name

Biomedical and Health Sciences

Zip code

Address

1-2-3, Kasumi, Minami-ku, Hiroshima

TEL

082-257-5385

Email

mikamiya@hiroshima-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Emi Miki

Organization

Hiroshima University

Division name

Biomedical and Health Sciences

Zip code

Address

1-2-3, Kasumi, Minami-ku, Hiroshima

TEL

082-257-5452

Homepage URL

Email

mikiemi@hiroshima-u.ac.jp

Institute

Graduate School of Biomedical and Health Sciences, Hiroshima University

Institute

Department

Personal name

Organization

JSPS KAKENHI

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Japan

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

2015

Year

09

Month

18

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

Completed

Date of protocol fixation

2015

Year

09

Month

17

Day

Date of IRB

Anticipated trial start date

2015

Year

10

Month

05

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2015

Year

09

Month

17

Day

Last modified on

2018

Year

03

Month

03

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020815