Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Other |
Change in sleep quality (scale of 0 to 21) |
Pittsburgh Sleep Quality Index will be used to measure the total aggregate score from the questionnaire on a scale of 0-21, with 21 indicating worst sleep quality |
Baseline, 12 weeks (end of intervention) and 24 weeks (end of follow-up period) |
|
Other |
Change in health-related quality of life (scale of 0 to 100) |
The Medical Outcomes Study Short Form-12 Survey will be used to measure mental component aggregate score and physical component aggregate score, each on a scale of 0-100, with a higher score indicating higher function, well-being or quality of life. The questions on physical functioning, role-physical limitations and bodily pain are summed to provide the physical aggregate score. The questions on social functioning, vitality, role-emotional limitations and mental health are summed to provide the mental aggregate score. |
Baseline, 12 weeks (end of intervention) and 24 weeks (end of follow-up period) |
|
Other |
Change in breast cancer-specific quality of life (scale of 0 to 28) |
The Functional Assessment of Cancer Therapy-Breast Questionnaire will be used to measure total score ranges from 0 to 28, with a higher score indicating higher function, well-being or quality of life. The results from each question are summed to provide the total score. |
Baseline, 12 weeks (end of intervention) and 24 weeks (end of follow-up period) |
|
Other |
Changes in feelings of happiness (scale of 1 to 11 and value in % over past 7 days) |
The Happiness Scale will be used to assess happiness with one question asking participants what is the average level of happiness over the past 7 days on a scale of 1 (extremely happy) to 11 (extremely unhappy). A second question asks participants what is the percentage of time spent happy (value in % over the last 7 days), neutral (value in % over the last 7 days) and unhappy (value in % over the last 7 days). |
Baseline, 12 weeks (end of intervention) and 24 weeks (end of follow-up period) |
|
Other |
Changes in perceived feelings of depression (scale from 0 to 27) |
The Patient Health Questionnaire provides a score of 0 to 27, with a higher score indicating higher feelings of depression. The results from each question are summed to provide the total score. |
Baseline, 12 weeks (end of intervention) and 24 weeks (end of follow-up period) |
|
Primary |
Change in sedentary time, light intensity physical activity time and moderate-vigorous intensity physical activity time (hours/day) |
Measured with accelerometry over seven days |
Baseline, 12 weeks (end of intervention) and 24 weeks (end of follow-up period) |
|
Secondary |
Change in body weight (kg) |
Measured with a standard beam scale |
Baseline, 12 weeks (end of intervention) and 24 weeks (end of follow-up period) |
|
Secondary |
Change in height (cm) |
Measured with a stadiometer |
Baseline, 12 weeks (end of intervention) and 24 weeks (end of follow-up period) |
|
Secondary |
Change in waist and hip circumference (cm) |
Measured with an anthropometric measuring tape |
Baseline, 12 weeks (end of intervention) and 24 weeks (end of follow-up period) |
|
Secondary |
Change in body composition (fat and lean mass in kg) |
Measured by Dual X-ray Absorptiometry (DXA) |
Baseline, 12 weeks (end of intervention) and 24 weeks (end of follow-up period) |
|
Secondary |
Change in cardiorespiratory fitness (VO2max) |
Measured by maximal cardiorespiratory fitness test using the multistage, modified Balke treadmill protocol |
Baseline, 12 weeks (end of intervention) and 24 weeks (end of follow-up period) |
|
Secondary |
Change in body mass index (BMI in kg/m2) |
Weight and height will be combined to report BMI |
Baseline, 12 weeks (end of intervention) and 24 weeks (end of follow-up period) |
|