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Table 1 Summary of Study Measures at Specified Time Points

From: Protocol for a phase III RCT and economic analysis of two exercise delivery methods in men with PC on ADT

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

    

  1. 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
  2. b Can be done on separate day to reduce participant burden
  3. c Will only be measured in participants who are not on continuous ADT for the duration of the intervention
  4. d Includes BIA, waist circumference, and waist circumference: height ratio
  5. e Only for those in supervised groups (done weekly)
  6. 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