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Table 1 Schedule of enrollment, interventions, and assessments

From: Eurythmy therapy versus slow movement fitness in the treatment of fatigue in metastatic breast cancer patients: study protocol for a randomized controlled trial

Study period

Screening

Baseline

Intervention

Follow-up

Time

14–1 days prior to baseline

0 (14–0 days prior to first training session)

Week 1

Week 2

Week 3

Week 4

Week 5

Week 6

Week 8

Week 10

Week 12

Week 14

Week 16

Week 18

Week 20

+ 6 months after week 20

+ 12 months after week 20

Enrolment

 Preliminary informed consent for FACIT-F administration

X

                

 Eligibility screen

X

                

 Informed consent

X

                

 Randomization

 

X

               

Intervention

 ERYT/CoordiFit sessions

  

1

2

3

4

5

6

7

8

9

10

11

12

13

  

Assessments

 Medical history and treatments

 

X

            

X

  

 Patient’s Baseline questionnaire

 

X

               

 FACIT-F

X1

       

X

  

X

  

X

X

X

 PSQI

 

X

      

X

  

X

  

X

X

X

 PHQ-9 and GAD-7

 

X

            

X

X

X

 BPI

 

X

      

X

  

X

  

X

X

X

 PRFS

 

X

            

X

X

X

 NCCN Distress Thermometer

 

X

      

X

  

X

  

X

X

X

 Mobility of the arm

 

X

      

X

  

X

  

X

X

X

 Therapist’s Questionnaire

  

X

X

X

X

X

X

X

X

X

X

X

X

X

  

 Patient diary

  

Every day

  

 Patient’s Last Session questionnaire

              

X

  

 Patient’s Follow-up questionnaire

               

X

X

 End of Study questionnaire

                

X

  1. BPI Brief Pain Inventory, FACIT-F Functional Assessment of Chronic Illness Therapy – Fatigue, NCCN National Comprehensive Cancer Network, PRFS Patient-Reported Functional Status, PHQ Patient health questionnaire, PSQI Pittsburgh Sleep Quality Index
  2. 1The patient will be asked to fill in the FACIT-F questionnaire only after he returns the signed preliminary informed consent
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Trials

ISSN: 1745-6215