Table 4 Primary and secondary outcomes and assessment methods
Outcome | Collection method | Assessment tool |
|---|---|---|
Primary outcome | ||
 Weight | Clinic visit | Tanita BWB-600 Wedderburn Scales |
Secondary outcomes | ||
 Anthropometry | ||
  Waist circumference | Clinic visit | Non-expandable tape measure |
  Hip circumference | Clinic visit | Non-expandable tape measure |
 Body composition & densitometry | ||
  Body composition (FM, FFM, LBM) | Clinic visit | Lunar Prodigy DXA - Total body and regional |
  Bone mineral density | Clinic visit | Lunar Prodigy DXA – Anterior-posterior lumbar spine (L1-L4); Bilateral proximal femur. |
 Cardio-metabolic & cancer-related biomarkers | ||
  Glucose, lipids, HbA1c | Fasting blood test | Standard assays on fresh blood |
  Other cardio-metabolic and cancer-related blood markers | Fasting blood test | Stored serum, plasma, buffy coat |
 Metabolic health & chronic disease risk | ||
  Blood pressure | Clinic visit | Welch Allyn 300 Series Vital Signs Monitor |
 Physical functioning | ||
  Hand grip strength | Clinic visit | Smedley dynamometer |
  Timed chair stands | Clinic visit | 5 stopwatch timed sit-to-stand transitions |
 Patient-reported outcomes | ||
  Quality of life | SAQ | PROMIS Global Health Scale [50] |
  Fatigue | SAQ | Functional Assessment of Chronic Illness Therapy – Fatigue Scale (FACTIT-Fatigue) [51] |
  Menopausal symptoms | SAQ | Greene Climacteric Scale [53] |
  Body image | SAQ | Body Image and Relationships Scale (BIRS) [56] |
  Fear of cancer recurrence | SAQ | Concerns about Recurrence Questionnaire – 4-items (CARQ-4) [58] |
  Arthralgia | SAQ | Breast Cancer Prevention Trial Symptom Scale – Musculoskeletal Pain subscale [59] |
  Peripheral neuropathy | SAQ | |
 Behavioral outcomes | ||
  Dietary intake | Telephone interview | 2 × 24-h dietary recalls |
  Physical activity | Objectively collected, Telephone interview | Actigraph GT3X+ tri-axial accelerometer Active Australia Survey [69] |
  Sitting time | Objectively collected | activPAL3TM monitor |