UMIN-CTR Clinical Trial

Basic information
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
Condition	breast cancer
Classification by specialty	Breast surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
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

Assessment
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

Base
Study type	Interventional

Study design
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

Intervention
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

Eligibility
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

Research contact person
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

Public contact
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

Sponsor
Institute	National Cancer Center
Institute
Department

Funding Source
Organization	National Cancer Center
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	National Cancer Center
Address	5-1-1, Tsukiji, Chuo-ku, Tokyo
Tel	0335422511
Email	tomishid@ncc.go.jp

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	2019 Year 04 Month 08 Day

Related information
URL releasing protocol	https://bmjopen.bmj.com/content/9/8/e030911
Publication of results	Published

Result
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

Progress
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
Other related information

Management information
Registered date	2019 Year 04 Month 03 Day
Last modified on	2021 Year 10 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000041451