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Table 1 Outcome variables for effect evaluation

From: Randomised controlled trial of a supervised exercise rehabilitation program for colorectal cancer survivors immediately after chemotherapy: study protocol

Variable

No. of items

Baseline

mid-int

post-int

fw

Primary and Secondary outcomes

     

Fatigue (FACIT-fatigue) [60]

13

Q

Q

Q

Q

QoL standard (SF-36) [62]

36

Q

Q

Q

Q

   physical functioning

10

Q

Q

Q

Q

   social functioning

2

Q

Q

Q

Q

   role limitations – physical

4

Q

Q

Q

Q

   role limitations – emotional

3

Q

Q

Q

Q

   general medical health

5

Q

Q

Q

Q

   bodily pain

2

Q

Q

Q

Q

   vitality

4

Q

Q

Q

Q

   mental health

5

Q

Q

Q

Q

   general medical perceptions

1

Q

Q

Q

Q

QoL cancer specific (EORTC QLQ-C30) [63]

30

Q

Q

Q

Q

   physical

5

Q

Q

Q

Q

   role

2

Q

Q

Q

Q

   cognitive

2

Q

Q

Q

Q

   emotional

4

Q

Q

Q

Q

   social

2

Q

Q

Q

Q

   fatigue

3

Q

Q

Q

Q

   pain

2

Q

Q

Q

Q

   nausea and vomiting

2

Q

Q

Q

Q

   global health and QoL

2

Q

Q

Q

Q

Physical Fitness

     

   MET value for final stage completed and heart rate at completion of second stage (Modified Bruce Submaximal Treadmill Protocol)

N/A

EP

EP

EP

EP

   Field Test (6-minute Walk Test)

N/A

EP

EP

EP

EP

Haematological Markers

     

   Full blood count

N/A

P

P

P

P

   Full iron studies

N/A

P

P

P

P

   IGF-1

N/A

P

P

P

P

   IGFBP-3

N/A

P

P

P

P

Additional Measures

     

Time since diagnosis

1

Q + MR

   

Stage of disease

1

Q + MR

   

Socio-demographic variables

10

Q

   

Physical Activity Behaviour

     

   Self-report recall (Active Australia + history question)

18 + 2

Q+T

T (no history)

T (no history)

T (no history)

   PA Logbook

24

LOG

LOG

LOG

LOG

BMI

2

EP

EP

EP

EP

WHR

2

EP

EP

EP

EP

  1. Q = written questionnaire, EP = Exercise Physiologist (RS), LOG = self-report logbook, T = telephone-delivered questionnaire, P = pathology lab, MR = Medical Records, QoL = Quality of Life, BMI = Body Mass Index, WHR = Waist Hip Ratio