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Table 1 Examinations and visits schedule

From: Feasibility and efficacy of a supervised home-based physical exercise program for metastatic cancer patients receiving oral targeted therapy: study protocol for the phase II/III - UNICANCER SdS 01 QUALIOR trial

  Baseline Physical activity program period Follow-up 1
(1st year)
Follow-up 2
(5 last years)a
M1 M2 M3
Inform Consent form      
CLINICAL EXAMINATION
Observance of oral targeted therapyb c  
Medical history and comorbidities      
Toxicities related to targeted therapyd Every 3 months  
Adverse events related to physical activityd     
Clinical examination & vital signse Every 3 months Every 3 monthsk
Survival Status   Every 3 months Every 3 monthsk
QUESTIONAIRES
General QoL (FACT-G, EQ-5D-3L)f Every 3 months  
Fatigue (FACT-F)f Every 3 months  
Nutrition (FAACT module AC/S) Every 3 months  
Cognitive Function (FACT-Cog) Every 3 months  
Food intake VAS      
Pain and fatigue VAS g g g Every 3 months  
Adherence to targeted therapy (Morisky-Green)   
Anxiety and Depression (HADS)   
Daily physical activity       
IPAQ    Every 3 months  
Booklet     
Questionning about the continuation of physical activity      Every 3 months  
OTHER ASSESSMENTS
Muscle mass, muscle density, adipose tissue (VAT and SCAT), Evaluation (TAP-CT)    h  
Physical capacitiesi E0 E1 E2 E3   
PARACLINICAL EXAMINATIONS
Tumor evaluationj    l k, l
Scintigraphy     
MRI     
BIOLOGICAL TEST
Biological Assessmentk   
INTERVENTION
Experimental Arm
SPEP Program
  Weekly:
- 1 supervised SPEP session at the patient’s home
- 2 non-supervised sessions
  
TRANSLATIONAL RESEARCH
Blood samplesm      
  1. A/CS Anorexia/cachexia subscale, ALAT Alanine transaminase, ASAT Aspartate transaminase, ALP Alkaline phosphatase, aPTT Partial thromboplastin time, Ca Calcium, CBC Complete blood count, CRP C-reactive protein, E Evaluation, EQ-5D-3L EuroQol-5 dimensions-3 levels, FAACT Functional assessment of anorexia/cachexia therapy, FACT-Cog Functional assessment of cancer therapy-cognitive, FACT-F Functional assessment of cancer therapy-fatigue, FACT-G Functional assessment of cancer therapy-general, γGT Gamma glutamyl transpeptidase, HADS Hospital anxiety and depression scale, HDL High-density lipoprotein, IPAQ International physical activity questionnaire, K Potassium, LDL low-density lipoprotein, M Month, Na Sodium, NCI-CTCAE National cancer institute - common terminology criteria for adverse events, PT/INR Prothrombin time and international normalized ratio, PWB Physical Well Being, QoL Quality of life, SCAT Sub-cutaneous adipose tissue, SPEP Supervised physical exercise program, T4 Thyroxine, TAP-CT Computed tomography of thorax, abdomen and pelvis, TP Prothrombin, TSH thyroid-stimulating hormone, VAS Visual analogue scale, VAT Visceral adipose tissue
  2. aEvery 3 months until disease progression (Tumor assessment according to standard procedures in centers). After progression, the survival status will be evaluated every 3 months until the end of the follow-up period or death
  3. bUsing the Morisky-Green questionnaire
  4. cUntil disease progression, death, toxicities, or patient/ investigator decision
  5. dUsing the NCI-CTCAE V4.03
  6. ePulse rate, blood pressure, temperature, weight
  7. fThe co-primary endpoint criteria are the fatigue scores (FACT-F) and the physical dimension scores (FACT-G – PWB) evaluated after 3 months
  8. gEvery week before and after SPEP for Arm A, once a week for Arm B
  9. hScanner at baseline, at 3 months (during the physical activity phase), and at the first follow-up visit (at 6 months after initiation of the physical activity for the SPEP group and 6 months after randomization for the standard group)
  10. iThe 6-min walking test, muscle force and function, pulse rate, height, weight, body surface area
  11. jTomodensitometry
  12. kHematology (CBC and platelet count), coagulation profile (PT/INR and aPTT), ionogram (NA, K, and Ca), lipid profile (cholesterol total, HDL, HDL, and triglycerides), kidney functions (bilirubin [total, direct, and indirect], ALAT, ASAT, γGT, and ALP), kidney functions (creatinine, creatinine clearance), albumin, thyroid (TSH, T4), CRP
  13. lAccording to standard of care in the center, with an evaluation during the first visit (6 months ±15 days from SPEP initiation [Arm A] or randomization [Arm B])
  14. mC-Peptide, Insulin Growth Factor 1, insulin, estradiol, and leptin