The NETFIT trial: Smart wearable medical devices to assess the quality of life of patients with metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NET).
Authors: Molina Cerrillomd Javier , Alonso-Gordoa Teresa , Grande Enrique , Benavent Marta , del Olmo Maria-Isabel , Custodio Ana B. , Hernando Jorge , Garcia-Carbonero Rocio , Teule Alex , Alonso Vicente , Pascual-Corrales Eider , Araujo-Castro Marta , Martinez Lago Nieves , Capdevila Jaume 
Published: June 2023

e13627

Background: Patients diagnosed with an advanced NET are frequently deteriorating their quality of life due to tumor volume, hormone-release related symptoms and treatment toxicity. Changes on lifestyle of patients with solid tumors have shown an improvement in quality of life. However, NET patients are missed in those studies. Methods: We conducted a prospective, multicenter, observational study that included 40 patients with advanced NETs from 10 Spanish hospitals belonging to the Spanish Taskforce Group of Neuroendocrine and Endocrine Tumors (GETNE). The aim of the trial was to assess and monitor changes on different aspects in quality of life by a customized smartphone app linked to an activity wearable tracker. Data were analyzed at baseline and monthly for 16 weeks after physical activity, sleep and nutritional intervention. The primary objective was to evaluate improvement in the quality of life of patients with metastatic G1 and G2 GEP-NETs based on changes registered on the EORTC QOL-C30-GI.NET21 questionnaire during the first 16 weeks since the onset of an active systemic treatment with somatostatin analogs. Secondary endpoints included description of changes in physical exercise and sleep variables from baseline, as well as the evaluation of functional scales in patients with or without carcinoid syndrome. Results: A total of 40 patients were included in the study and all quality of life questionnaires were collected from week 0 to week 16 from 25 patients. In 15 patients there was a lack of compliance filling the questionnaires. All of the 25 patients analyzed experienced an improvement in at least one of the items of the QOL-C30 questionnaires of the primary endpoint after the first 16 weeks. As secondary outcomes it was shown a trend towards an improvement in vital signs, such as decrease in systolic blood pressure (median W0:130.7mmHg to W16:124.3mmHg p=0.3), diastolic (W0:88.7mmHg vs W16:83.3mmHg p=0.4) and heart rate (W0:93.3bpm vs W16:86bpm p=0.25). In addition, an improvement in sleep quality was observed, measured by the amount of deep REM sleep (W0:102.59 vs W16:115.3 median min/day p=0.31) or periods of light non-REM sleep (W0:301,43 vs W16:341,1 median min/day p=0.21). In the EORTC QLQ-C30 questionnaire, an improvement was observed in all functional scales (emotional function mean functional improvement (MFI) 5.3 (p=0.2), cognitive function MFI 4.0 (p=0.27), social function MFI 6.0 (p=0.3)), being deeply significant in role function (MFI 13.3 points; p=0.0156). There was an improvement in the symptomatology scales between W0 and W16, fatigue -3.7 p=0.3, nausea -1.3 p=0.5, pain -2.5 p=0.3, insomnia -9.7 p=0.05, anorexia -2.7 p= 0.3, diarrea -17.3 p=0.01. Conclusions: NETFIT trial showed that lifestyle intervention has a significant impact on the quality of life and symptomatic control of patients with metastatic G1/2 GEP-NETs.