Domain/Measure | Time required | T0: (Baseline) | T1: (3 mo.) | T2:6 mo. (End Int.) | T3: 9 mo. (3 mo. f/u) | T4:12 mo. (6 mo. f/u) |
---|
Quality of life |
FACT-P | 4–5 min | ● | ● | ● | ● | ● |
FACT-G | 8–10 min | ● | ● | ● | ● | ● |
FACT-F (co-primary) | 5 min | ● | ● | ● | ● | ● |
Physical Fitness |
6MWT (co-primary) | 6 min | ● | ● | ● | ● | ● |
Sit-to-Stand Test | 1 min | ● | ● | ● | ● | ● |
Grip Strength | 1 min | ● | ● | ● | ● | ● |
Biological Outcomesa | < 5 min | ● | | ● | | ● |
Blood glucose | | | | | | |
Cholesterol profile | | | | | | |
PSA (safety) | | | | | | |
Testosteronec | | | | | | |
Haemoglobin (covariate) | | | | | | |
HbA1c (covariate) | | | | | | |
Body Composition |
Bone mineral density | 30 minb | ● | | | | ● |
Body compositiond | 5 min | ● | | ● | | ● |
Adherence | | | | | | |
Accelerometer | – | ● | ● | ● | ● | ● |
GLTEQ | < 5 min | ● | ● | ● | ● | ● |
Sessional attendancee | – | | | | | |
Adherence Predictor Variables |
HCCQ | 5 min | ● | | | | |
BREQ2 | 5 min | ● | | ● | | ● |
PNSF | 5 min | ● | | ● | | ● |
PAB | 5 min | ● | | ● | | ● |
Sedentary Behaviours | 5 min | ● | | ● | | ● |
Cost-Effectiveness |
Health questionnaire | 5 min | ● | ● | ● | ● | ● |
EQ-5D | 5 min | ● | ● | ● | ● | ● |
Study Completion | 5 min | | | | | ● |
- a All biological measures are considered to be standard of care at baseline and 12 months. PSA is considered to be standard of care at all 3 time points. Blood glucose, cholesterol profile, and haemoglobin tests at 6 months are NOT standard of care
- b Can be done on separate day to reduce participant burden
- c Will only be measured in participants who are not on continuous ADT for the duration of the intervention
- d Includes BIA, waist circumference, and waist circumference: height ratio
- e Only for those in supervised groups (done weekly)
- Abbreviations: 6MWT 6 min walk test, BREQ2 Behavioral Regulations in Exercise Questionnaire – 2, EQ-5D EuroQol 5 dimensions of health scale, FACT-G Functional Assessment of Cancer Therapy General, FACT-F Fatigue subscale, FACT-P Prostate subscale, GLTEQ Godin Leisure Time Exercise Questionnaire, HbA1c glycated hemoglobin, HCCQ Health Care Climate Questionnaire, Int Intervention, PAB Planning, Attitudes, & Behaviour questionnaire, PSA prostate-specific antigen, PNSF Psychological Need Support and Frustration Scale – Relatedness Items