Tumori Journal Abstract Book - October 2020 - 198

198
1
SC Oncologia Falck, Ospedale Niguarda, Milano, Italy, Milano; 2Oncologia
Medica 1, AOU Città della Salute e della Scienza, Torino, Italy, Torino; 3Unità
di Biostatistica e Sperimentazioni Cliniche, Istituto Scientifico Romagnolo
per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy, Meldola;
4
Clinica di Ematologia, AOU Ospedali Riuniti Umberto I, G.M. Lancisi, G.
Salesi, Ancona, Italy, Ancona; 5Terapie Cellulari e Medicina Trasfusionale,
AOU Careggi, Firenze, Italy, Firenze; 6Unità di Ricerca e Sviluppo Clinico S.C.
Oncoematologia Pediatrica, AOU Città della Salute e della Scienza - Presidio
Ospedaliero Infantile Regina Margherita, Torino

Background: In the last decade, patient's medical records
have undergone significant changes: progressively moving
from the traditional paper version to the digital one. The
consequently increasing importance of digital information
technology brought to the implementation of Electronic
Medical Record (EMR). The digitalization process proceeds
and will lead in the next future to the complete replacement
of paper-based documents with full-digital medical records.
In this context, ICH-GCP R2 and EU GMP Annex 11 have
established the basic requirements for validated EMR systems to preserve integrity and security of data, as well as to
define the prerequisites of source documents for clinical
trials.
Methods: The Italian Group of Data Managers (GIDMcrc)
has spread among the professionals involved in Italian
clinical research an online survey aimed to review the
characteristic of medical records and source documents
used at the experimental sites.
Results: The survey has been filled by 118 professionals
(112 study coordinators, 2 quality assurance, 4 others),
mainly coming from public hospitals (42,7%) followed by
university hospitals (22,3%), public IRCCS (20,39%) and
private IRCCS (12.6%). The majority of sites have a mixed
digital-paper source documents system (66,0%), while a
totally paper system is present in 27,2%, and only the 6,8%
have a full digital source documents system. Only 59,2%
of the centres has an organized EMR, but just in the 32,8%
of these EMR is validated according to ICH-GCP R2 and
GMP annex11.
Despite the presence of digital source documents and
EMR, the Source Documents Verification (SDV) is carried
out on paper certified copies in 60,8% of these sites, in
11,8% on electronic record by the CRA together with the
study coordinator and only in 10,7% the CRA has a direct
access to electronic source documents/EMR.
Conclusions: This survey highlights the great heterogeneity between experimental sites on their actual level of
digitalization. Most of the Italian sites has an organized
EMR, although often does not achieve the validation
according to GCP and GMPannex11. This situation leads
to a prevalence of mixed electronic/paper source documents system against full paper and full electronic system. Furthermore, in most of the cases the SDV is carried
out on paper certified copies. This data suggests how digitalization is a currently ongoing process, which still needs
more investments and time to achieve the completion,
conforming to quality requirements.

Tumori Journal 106(2S)

T43
"NEW LIFE" LILT PROJECT: recovering
the Psychosocial well-being of
Cancer Patients
Carrozza F.1, Farina P.2, D'Addario D.2, D'Aulerio M.3, Spina C.3,
Iorio E.3, Scipioni M.3, Antonecchia P.3, Bellomo M.3, Carfagno G.3,
Fabrizio G.3, Trivisonne R.4, Sbrolla B.4, Giorgi F.5, Cicconi A.4, Di
Battista S.4, Franchella C.3
1
D.H. Oncology S. Timoteo Hospital-ASReM, Termoli (CB); 2D.H. Oncology
S. Timoteo Hospital-ASReM, Termoli; 3LILT Campobasso Provincial
Association, Termoli; 4LILT Ascoli Piceno Provincial Association, Ascoli Piceno;
5
D.H. Oncology "Madonna del Soccorso" Civil Hospital - ASUR Marche S.
Benedetto del Tronto (AP), S. Benedetto del Tronto (AP)

Background: The following study aimed to improve the
quality of life of cancer patients undergoing cancer treatment or cancer follow-up through the integration of a psychosocial rehabilitation pathway, and students of high
school of Larino (CB) and Ascoli Piceno (AP) involved for
the project's didactic part on the relationship between
nutrition, physical activity and tumours, and encourage
volunteering initiatives.
Patients and Methods: The study involved 225 pts with
cancer disease of the Termoli and San Benedetto oncological D.H., 115 and 110 pts, respectively. Pts were included
in this longitudinal observational study on a voluntary
basis, upon signing an informed consent. A "Newlife" IT
database was created for collecting data through a dedicated oncology desk. Psychological and nutritional assistance was offered to the involved patients. Psychological
assessment of the pts was performed through Psychological
Distress Inventory (PDI), Need Evaluation Questionary
(NEQ) questionnaires, clinical interviews. Nutritional
assessment was performed through Mini Nutritional
Assessment (MNA) screening questionnaire and subsequent evaluations. Parameters such as body mass index
(BMI), phase angle (PA) and bioelectrical impedance analysis (BIA) were recorded. A satisfaction questionnaire was
administered to all 225 pts.
Results: All the pts (147 women, 78 men, average age:
63, range 31-89) were involved from November 2018 to
December 2019. The most frequently reported pathologies affected breast (75 pts) and colorectal cancer (41
pts). At the time of recruiting, 123 pts were in active
treatment for metastatic disease, 50 pts in adjuvant cancer treatment, and 52 pts in follow up. Among all the pts
involved, 193 pts completed a PDI and NEQ questionnaires. Among the pts completing the PDI, 57 pts reported
severe distress (>35). The most urgent needs the NEQ
detected concerned communication and information on
the disease status. A very low BMI (<21) was reported in
pts with head-neck, gastric, pancreatic and oesophageal
cancer. Experiential and laboratory activities were realised for pts and their families and creative activities were
also carried out at schools.

Tumori Journal Abstract Book - October 2020

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