| T0 | T1 | T2 | T3 | |
---|---|---|---|---|---|
Outcomes | Instrument | Baseline | Month 3 ± 14 days | Month 6 ± 14 days | Month 9 ± 21 days |
Primary outcomes | |||||
 Cancer-related fatigue | EORTC QLQ-FA12 | X | X | X | X |
 Health-related quality of life | EORTC QLQ-C30 | X | X | X | X |
Secondary outcomes | |||||
 Patient-reported outcomes | |||||
  Breast cancer-specific symptoms | EORTC QLQ-BR45 | X | X | X | X |
  Depression and anxiety | Patient Health Questionnaire (PHQ-4) | X | X | X | X |
  Sleep problems | Pittsburgh Sleep Quality Index (PSQI) | X | X | X | X |
  Pain | Brief Pain Inventory Short Form (BPI-SF), PainDETECT, Pain Catastrophizing Scale (PCS) | X | X | X | X |
  Quality of working lifea | Quality of Working Life Questionnaire for Cancer Survivors (QWLQ-CS) | X | X | X | X |
  Subjectively measured physical activity | Modified version of the GODIN questionnaire | X | X | X | X |
  Productivity loss | Productivity Cost Questionnaire (iPCQ) |  | X | X | X |
  Healthcare resources consumption | Medical Consumption Questionnaire (iMCQ) |  | X | X | X |
  Health-related quality of life | EQ-5D-5L | X | X | X | X |
  Urinary incontinence | International Consultation on Incontinence Questionnaire -Urinary Incontinence Short Form (ICIQ-UI SF)b | X | X | X | X |
  Satisfaction with exercise interventiong | Self-developed questionnaire |  | X | X | X |
 Physical measurements | |||||
  Physical performance | 5-times sit-to-stand, short Fullerton Advanced Balance (S-FAB) scale | X | X | X |  |
  Physical fitness | Steep Ramp Test (SRT), endurance cycle test, handgrip- and leg strength test, Cardiopulmonary Exercise Testing (CPET)c, Isokinetic and isometric peak torqued | X | X | X |  |
  Objectively measured physical activity | Physical activity tracker (Fitbit Inspire HR) | X | X | X | X |
  Muscle thicknesse | Ultrasonography | X | X | X |  |
  Body composition | Bio-impedance, DEXAf | X | X | X |  |
  Anthropometry | • Body weight | X | X | X |  |
• Waist and hip circumference | X | X | X |  | |
• Height | X |  |  |  | |
  Resting heart rate and blood pressure | - | X | X | X |  |
  Blood markers | Plasma, serum, buffy coat and peripheral blood mononuclear cells | X | X | X |  |
Socio-demographic and medical data | |||||
 Socio-demographic data | Self-developed questionnaire | X |  |  |  |
 Medical history and concomitant diseases | Medical records | X | X | X | X |
 Cancer progress and treatment over the course of the study | Medical records | X | X | X | X |
 Cancer characteristics and treatment history | Medical records | X | X | X | X |
 Concomitant medication | Medical records | X | X | X | X |
 Adverse events | Reports of patients, trainers, oncology nurses, physicians or medical records | X | X | X | X |
 Overall and breast-cancer-specific survival and progression-free survival | Medical records and/or cancer registry | Up to 5 years after the 9-month intervention period |