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 | ● | ● |