breast cancer
Conditions
Interventions
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,
(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
s level of strength.
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 devic
Sponsors
National Cancer Center
Eligibility
Sex/Gender
Female
Inclusion criteria
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.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cardiorespiratory fitness: VO2 peak | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactYoichi Shimizu
National Cancer Center Hospital Division of Nursing
Outcome results
None listed