UMIN-CTR Clinical Trial

Public title

Effect of home-based high intensity intermittent training and behavioral modification using information and communication technology on cardiorespiratory fitness and exercise habits among sedentary breast cancer survivors: habit-B study protocol for a randomized controlled trial

Acronym

Development of home-based exercise program for breast cancer survivors: habit-B

Scientific Title

Effect of home-based high intensity intermittent training and behavioral modification using information and communication technology on cardiorespiratory fitness and exercise habits among sedentary breast cancer survivors: habit-B study protocol for a randomized controlled trial

Scientific Title:Acronym

Development of home-based exercise program for breast cancer survivors: habit-B

Region

Japan

Condition

breast cancer

Classification by specialty

Breast surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

We will investigate whether habit-B program improves the VO2 peak compared to a control group as well as to confirm its safety and feasibility.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Cardiorespiratory fitness: VO2 peak

Key secondary outcomes

Physical Function: six-minute walk test (m), Walking speed (m/sec), One-repetition maximum (1RM) for leg press, Grip strength, chair stand test, functional reach test, two-step test, body composition
Physical Activity Level: Global Physical Activity Questionnaire (GPAQ) , wearable activity monitor
Subjective Measures: Fear of cancer recurrence (FCR), Concerns About Recurrence Scale (CARS), Patient Health Questionnaire-9 (PHQ-9), Cancer Fatigue Scale (CFS), Athens Insomnia Scale (AIS), EuroQol 5 Dimension (EQ-5D)
Adverse event rate
Biological assessments: gut microbiota, intestinal metabolite, intestinal immunity, Blood polyunsaturated fatty acids
Medical economical cost: cost-benefit analysis, number of staffs, working hours, labor cost, equipment costs, office expenses, number of unexpected medical consultations, direct medical cost, other medical service usage
Return to work

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

No treatment

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is not considered as adjustment factor.

Blocking

Concealment

Central registration

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Other

Interventions/Control_1

habit-B program group
The habit-B program will be combined with home-based exercise support utilizing six weeks of exercise counseling/exercise guidance and twelve weeks of ICT (e-mail, application, wearable device). The participants will encourage to complete the following high intensity interval training (HIIT) using body weight exercises below 10-minute training session three times each week for twelve weeks (a total of 36 sessions during the trial period): (1) one 10-minute session of exercises focused on the lower limbs; (2) a total of 10 minutes composed of a 3-minute warm-up, 4-minute training (8 sets of 20 sec exercise, 10 sec rest), and 3-minute cool-down; (3) the above training exercises are designed to increase in intensity each week; (4) the details of the above exercises are divided into three stages according to cardiorespiratory fitness (VO2 peak) at Week 0 and the contents of training are designed to increase physical strength incrementally in accordance with the individual's level of strength.

Interventions/Control_2

Control group
In the control group, wearable devices will be distributed and support provided for setup at the start of the intervention. Self-monitoring using the wearable device will be recommended during the trial period. There are no reports of increasing VO2 peak with the use of a wearable device alone, and there are reports ruling out their efficacy with regard to effects on exercise habits. In this study the control group will utilize wearable devices for the purpose of monitoring physical activity.

Interventions/Control_3

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

60

years-old

>

Gender

Female

Key inclusion criteria

(1) female, ages 20 to 59 years diagnosed (stages I-IIa); (2) diagnosed with invasive breast cancer, within 2 to 13 months after surgery; (3) not requiring cancer drug treatment aside from hormone therapy; (4) less than two days of 30 min (in total of 60 min) per week over moderate intensity); (5) ability to complete an electronic patient reported outcome (e-PRO) using smartphone; (6) consent to trial participation can be obtained in writing from the patient themselves; and (7) can read, write, and understand Japanese.

Key exclusion criteria

(1) judged to have severely reduced cognitive function by a primary physician; (2) exercise judged to be risky by a primary physician; (3) history of smoking within in the previous 12 months; (4) BMI of 30 or above; (5) ECG abnormality indicated in preoperative testing, resting heart rate (HR) below 60 beats/min or above 100 beats /min, stage III hypertension or above (diastolic blood pressure over 110 mmHg or systolic blood pressure of over 180 mmHg); (6) judged unfit for the trial by a primary physician for other reasons.

Target sample size

60

Name of lead principal investigator

1st name	Yutaka
Middle name
Last name	Matsuoka

Organization

National Cancer Center

Division name

Center for Public Health Sciences

Zip code

104-0045

Address

5-1-1, Tsukiji, Chuo-ku, Tokyo

TEL

0335475201

Email

yumatsuo@ncc.go.jp

Name of contact person

1st name	Yoichi
Middle name
Last name	Shimizu

Organization

National Cancer Center Hospital

Division name

Division of Nursing

Zip code

104-0045

Address

5-1-1, Tsukiji, Chuo-ku, Tokyo

TEL

0335475201

Homepage URL

Email

yoshimiz@ncc.go.jp

Institute

National Cancer Center

Institute

Department

Personal name

Organization

National Cancer Center

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

National Cancer Center

Address

5-1-1, Tsukiji, Chuo-ku, Tokyo

Tel

0335422511

Email

tomishid@ncc.go.jp

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

2019

Year

04

Month

08

Day

URL releasing protocol

https://bmjopen.bmj.com/content/9/8/e030911

Publication of results

Published

URL related to results and publications

https://doi.org/10.1136/bmjspcare-2021-003141

Number of participants that the trial has enrolled

50

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

2021

Year

08

Month

13

Day

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Main results already published

Date of protocol fixation

2019

Year

03

Month

13

Day

Date of IRB

2019

Year

02

Month

28

Day

Anticipated trial start date

2019

Year

05

Month

20

Day

Last follow-up date

2021

Year

05

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2019

Year

04

Month

03

Day

Last modified on

2021

Year

10

Month

07

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041451