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Table 2 Assessments and instruments used in the BEST study

From: Randomized controlled trial to evaluate the effects of progressive resistance training compared to progressive muscle relaxation in breast cancer patients undergoing adjuvant radiotherapy: the BEST study

Outcomes

Instrument

T0

T1

T2

T3

T4

T5

Primary endpoint

       

Fatigue

Fatigue assessment questionnaire (FAQ)

X

X

X

X

X

X

Secondary endpoints

       

Quality of life

EORTC QLQ30 / BR-23 questionnaire

X

X

X

X

X

X

Depression

Center for Epidemiological Studies Depression Scale (CES-D)

X

X

X

X

X

X

Cognitive function

Trail-making-test

X

X

X

 

X

X

Body composition

Bioimpedance analysis, weight, height, waist and hip circumference

X

X

X

 

X

X

Muscle strength

Isometric and isokinetic strength of representative muscle groups for upper and lower extremity measured at the IsoMed2000®

X

 

X

 

X

X

Cardio-respiratory fitness

Spiroergometry (VO2peak)

X

 

X

 

X

X

Flexibility

Range of motion measured at the IsoMed2000®

X

 

X

 

X

X

Radiotoxicity

Acute radiation dermatitis, LENT-SOMA classification for late effects, ECOG performance status, hemoglobin , and thrombocytes at end of radiotherapy

 

X

X

   

Circulating immune cells

Analyzed in peripheral blood

X

X

X

   

Biomarkers of inflammation and oxidative stress

Analyzed in peripheral blood and urine

X

X

X

   

Salivary cortisol

Saliva collected at five different time points during a day

X

X

X

   

Sample collection data

Date and time of collection, as well as time since last food or fluid intake, vigorous physical activity (during last 12 h), NSAID intake (during last 12 h), smoking (during last 24 h), caffeine intake (during last 6 h), alcohol intake (last 48 h), acute infections, and sleep quality during last night are recorded.

X

X

X

   

Safety of training interventions

Number of participants with lymphedema, pain, nausea, dyspnea, or tachycardia during the intervention phase

at each training session

Others

       

Socio-demographic factors

Recording of date of birth, education, occupation, socio-familial situation, smoking, alcohol consumption

X

     

Breast cancer characteristics

Family history, TNM status, grading, ER/PR status, HER2-score, p53, bcl-2, Ki-67,

X

     

Medical history

Recording of pre-existing diseases and of allergies

X

     

Treatment data

Pre-treatment: ECOG at diagnosis, date and type of breast surgery, affected lymph nodes, (neo-) adjuvant chemotherapy (type, last infusion), hormone therapy

 

X

    

Radiation: technique (3D, IMRT), type and dose, start and stop date, interruptions

Concomitant medication

Recorded at each visit on a medication log form

X

X

X

   

Physical activity history

Physical activity in adolescence, pre-diagnosis, during, and after intervention is recorded, including walking, cycling, and sports

X

 

X

X

X

X