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Table 3 Assessments

From: The impact of physical activity on fatigue and quality of life in lung cancer patients: a randomised controlled trial protocol

 

Investigations

Timing

History and Physical Exam including:

· Height (baseline only)

0,2,4, 6 months

 

· Weight and Body Mass Index (BMI)

 
 

· Blood Pressure and Heart Rate

 
 

· Oxygen saturation (SaO2) (on room air)

 
 

· Concomitant medications (any changes to baseline meds)

 
 

· Colinet Co-morbidity Score

 
 

· Eastern Cooperative Oncology Group Performance Status (ECOG PS)

 
 

· Disease status

 
 

· Current treatments

 

Fitness Testing

· 6-minute walk test (6MWT)

0,2,4, 6,months

 

· Senior’s Fitness Test

 
 

· Hand grip strength

 

Pulmonary Function

· Forced Expiratory Volume at 1 second (FEV1)

0,2,4,6 months

 

· Forced Vital Capacity (FVC)

 

Adverse Events

· Adverse events will be recorded and graded using National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0 (NCI CTCAE v3.0)

0,2,4, 6 months

Patient Reported Outcomes

· Functional Assessment of Cancer Therapy - Fatigue (FACT-F subscale)

0,2,4,6 months

 

· Quality of Life (QOL) European Organisation for Research and Treatment of Cancer –Quality of life questionnaire – Core (EORTC-QLQ-C30) and Lung module (LC-13 subscale)

 
 

· Depression and Anxiety (General Health Questionnaire - GHQ12)

 
 

· Sleep Quality (Pittsburgh Sleep Quality Index - PSQI)

 
 

· Cognitive Function (Functional Assessment of Cancer Therapy – Cognitive scale - FACT-COG v3)

 
 

· Distress (Distress Thermometer)

 
 

· Dyspnoea (The University of California, San Diego Shortness of Breath Questionnaire -SOBQ)

 
 

· Activities of Daily Living (ADLs) and Independent Activities of Daily Living (IADLs)

 
 

· Sedentary time (Sitting Questionnaire)

 
 

· Physical activity attitudes (Social Cognitive Determinants of Exercise questionnaire)

 

Physical Activity Behaviour/ Adherence

· Physical activity participation (Active Australia)

0,2,4, 6 months

 

· Accelerometer -for one week prior to each assessment

 

Other Investigations

· Fasting Serum/plasma collection for correlative studies and optional banking

0,2,4,6 months

 

· Glasgow Prognostic score: Full blood count (FBC), Albumin, C-reactive protein (CRP)

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