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Table 2 Schedule of study assessments

From: Engaging the older cancer patient; Patient Activation through Counseling, Exercise and Mobilization – Pancreatic, Biliary tract and Lung cancer (PACE-Mobil-PBL) - study protocol of a randomized controlled trial

Time (week no.)

-2 to 0

0

1

2

3

4

5

6

7

8

9

10

11

12

13

17

Enrollment

 Eligibility screen

X

               

 Informed consent

X

               

 Randomization

 

X

              

Intervention

  

X---------------------------------------------------------------------------------------------------------------------------X

  

Physical tests and examinations

 30s-CST (primary outcome)

X

       

X

     

X

X

 6MWT

X

       

X

     

X

X

 Handgrip strength

X

       

X

     

X

X

 Gait speed test

X

       

X

     

X

X

 Physical activitya

X

             

X

 

 DXA

X

             

X

 

 BI

X

             

X

 

 Body weighta

X

       

X

     

X

X

 Inflammatory biomarkers

X

       

X

     

X

X

PROMs

 PRPS

X

       

X

     

X

X

 MDASIa

X

       

X

     

X

X

 EORTC-QLQ-C30

X

       

X

     

X

X

 HADS

X

       

X

     

X

X

Qualitative exploration

                

 Individual Interviews

              

X

 

Feasibility

 Adherence

X

X

X

X

X

X

X

X

X

X

X

X

X

X

  

 Attrition

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

 Adverse events

X

X

X

X

X

X

X

X

X

X

X

X

X

X

  

Oncological treatment

 Treatment related toxicityb

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

 Dose-reductionsb

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

Hospitalizations

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

Survival

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

  1. aOnce weekly for participants in the intervention group bRegistered for every treatment course
  2. Abbreviations: 30s-CST 30-s chair stand test, 6MWT six-minute-walk-test, BI bioelectrical impedance, DXA whole-body dual-energy x-ray absorptiometry, EORTC-QLQ-C30 European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30, HADS Hospital Anxiety and Depression Scale, MDASI M.D. Anderson Symptom Inventory, PRPS patient-reported performance status