Table 3.
Overview of study assessments of the VIVROVAIRE TR Study
| Study Period | |||
|---|---|---|---|
| Enrollment | Step 1 | Step 2 | |
| Eligibility Screen | • | ||
| Informed Consent | • | ||
| Disease medical history | • | ||
| Chronic fatigue, quality of life and late effects of chemotherapy | • | ||
| ✓ Fatigue (MFI-20a) | • | ||
| ✓ Quality of life (FACT-Gb/FACT-Oc) | • | ||
| ✓ Neurotoxicity (FACT/GOG-NTXd) | • | ||
| ✓ Cognition (FACT-Coge) | • | ||
| ✓ Day-to-day life (Living condition questionnaire) | • | ||
| ✓ Anxiety /Depression (HADSf) | • | ||
| ✓ Insomnia (ISIg) | • | ||
| ✓ Physical activity (IPAQh) | • | ||
| ✓ EQ-5Di (For patients only) | • | ||
| Specialized medical examination | • | ||
| Cardiovascular: | |||
| a) Cardio-vascular medical examination with non-invasive tests to explore heart disease (by a cardiologist) | • | ||
| - Electrocardiogram | • | ||
| - Echocardiography | • | ||
| -Coronary endothelium-dependent vasoreactivity testing (optional exam) | • | ||
| b) Non-invasive vascular tests to explore atherosclerosis: | • | ||
| - Systolic index of lower and upper limbs, | • | ||
| -Ultrasound images to measure carotid intima media thickness | • | ||
| - Capillaroscopy to assess Raynaud’s syndrome (optional exam) | • | ||
| c) Specific cardiac biological tests: | • | ||
| High-sensitive cardiac troponin, BNP, Von Willebrand factor (VWf), tissular Plasminogen Activator (t-PA). | • | ||
| Respiratory & Hearing: | • | ||
| - Respiratory Function Tests (RFT) | • | ||
| - Audiogram | • | ||
| Blood sampling: exploring metabolic and hormonal disorders | • | ||
| - Hormonal assessment: sex hormone binding globulin (SHBG), Luteinizing hormone (LH), Follicle-stimulating hormone (FSH), Estradiol, Anti-Müllerian hormone (AMH), thyroid stimulating hormone (TSH). | • | ||
| -Carbohydrate-lipid balance: fasting blood glucose and insulin, lipid fractions, triglycerides; | • | ||
| - Osteocalcin blood Tests: calcium, phosphorus, vitamin D | • | ||
| - Renal assessment: ionograms, creatinine level | • | ||
| -Hepatic assessment: transaminases (TGO, TGP), Aspartate Aminotransferase (ASAT), Alanine Aminotransferase (ALAT), Alkaline Phosphatase (PAL), Gamma-glutamyl transferase (GGT), Lactate dehydrogenase (LDH | • | ||
| - C-Reactive Protein Test ultrasensitive | • | ||
aMFI Multidimensional Fatigue Inventory;bFACT-G General Functional Assessment of Cancer Therapy; cFACT-O Functional Assessment of Chronic Therapy- Ovarian subscale,dFACT/GOG-Ntx Functional Assessment of Cancer Therapy/ Gynecologic Oncology Group–Neurotoxicity subscale; eFACT-Cog Functional Assessment of Cancer Therapy-Cognitive;fHADS Hospital Anxiety and Depression Scale,gISI Insomnia Severity Index,hIPAQ International Physical Activity Questionnaire; iEQ-5D Euroqol questionnaire