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Table 1 Sequence of trial measurements for primary and secondary outcomes

From: Mindful Yoga for women with metastatic breast cancer: design of a randomized controlled trial

 

Pre-Screening

Telephone Screening

Baseline

Treatment

Mid-Treatment

Treatment

Post-Treatment

3-Month Follow-up

6-Month Follow-up

VISIT, Time (weeks)

(-16-0)

(-13-0)

1 (-4–0)

2–4 (1–3)

5 (4)

6–9 (6–8)

10 (9)

11 (21)

12 (34)

Primary outcome measures

 Attendance at intervention sessions

   

X

 

X

   

 Client Satisfaction Questionnaire-8

      

X

  

Secondary outcome measures

 Brief Pain Inventory-Short Form

  

X

   

X

X

X

 Brief Fatigue Inventory

  

X

   

X

X

X

 Pittsburg Sleep Quality Index

  

X

   

X

X

X

 Hospital Anxiety & Depression Scale

  

X

   

X

X

X

 Mindfulness questionnaire (FFMQ-SF)

  

X

   

X

X

X

 Complementary/alternative medicine use

  

X

   

X

X

X

 6-min Walk Test

  

X

   

X

X

X

 Medical record review

X

 

X

   

X

X

X

 ECOG or KPS

X

        

 Demographics

  

X

      

 Daily diary items

   

X

 

X

   

 Medication log

  

X

 

X

 

X

X

X

 Health questionnaire

  

X

      

 Treatment expectations

  

X

 

X

    

 Adverse events

  

X

X

X

X

X

X

X