Cancer related fatigue Breast Cancer, Cancer related fatigue
Conditions
Interventions
cardiac rehabilitation, Tai Chi video , a combination of both, and instruction using educational pamphlets alone
Cancer related fatigue, cardiac rehabilitation, Tai Chi video
Sponsors
Kawaguchi-Sakita Nobuko
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Stage I to III breast cancer patients, age 18 years or older 2.Plan to continue chemotherapy for 9 weeks or more (no restrictions on regimen) 3.Moderate to severe fatigue (fatigue level 4-10 or higher) determined using the Piper Revised Fatigue Scale (PFS-R) 4.Regular moderate exercise 150 minutes or less per week 5.Able to participate in the program twice a week 6.Able to answer questionnaires and check emails using a smartphone 7.Able to read, write, and understand Japanese 8.Performance Status (ECOG Scale) of 0 or 1
Exclusion criteria
Exclusion criteria: 1) Patients have fatigue due to factors other than CRF. 2) Patients have active overlapping cancers (however, lesions equivalent to carcinoma in situ or intramucosal cancer that are judged to be cured by local treatment are not included in overlapping cancers). 3) Patients have contraindications to the CR program or Tai Chi (unstable angina, acute compensated congestive heart failure, complex ventricular arrhythmia, uncontrolled inflammatory or infectious conditions, or musculoskeletal conditions that prevent full participation in exercise, etc.), or are judged to have difficulty walking for more than 6 minutes. 4) Patients are judged to have severe cognitive impairment or psychiatric illness and are currently undergoing treatment. 5) For any other reason that the principal investigator or co-investigator judges the patient to be inappropriate as a subject.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of days on which exercise was performed relative to the number of scheduled days | — |
Secondary
| Measure | Time frame |
|---|---|
| a) Percentage of patients who completed each exercise session b) Duration of exercise in each group c) Number of exercise sessions in each group d) Satisfaction based on the Customer Satisfaction Questionnaire (CSQ-8) e) Amount of exercise measured by FitBit f) Adverse events due to the intervention (CTCAE) g) Fatigue based on the Piper Fatigue Scale-Revised (PFS-R) h) Health-related quality of life (HR-QoL) i) Symptom assessment based on the Edmonton Symptom Assessment System (ESAS) j) VO2 peak and VO2 max, motor function assessment k) Resting HR, maximum HR, number of steps, distance, calorie consumption, duration of each sleep stage, wake time (FitBit) | — |
Contacts
Public ContactNobuko Kawaguchi-Sakita
Kyoto University Hospital
Outcome results
None listed