CompletedNot Applicable

Implementation of a CDSS in Oncology Patients During COVID-19

Greece44 participantsStarted 2020-03-11

Plain-language summary

The present randomised controlled trial aimed to investigate the effectiveness of a clinical decision support system (CDSS) in assisting clinicians to apply nutritional care to breast cancer (BC) patients during the COVID-19 pandemic in Greece. Adult BC women (stages I-IIIA) who underwent mastectomy followed by hormone therapy were randomly assigned either to the Control group, receiving general nutritional advice, or the Intervention (or CDSS) group, in whom a personalised nutritional programme based on the Mediterranean diet together with physical activity guidelines were provided, all produced by CDSS. Medical and dietary history, anthropometrics, biochemical indices and quality of life characteristics were assessed both at baseline and at the end of the study (3 months).

Who can participate

Age range37 Years – 68 Years

SexFEMALE

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Inclusion criteria: * Adult women (≥ 37 years of age); * histological evidence of primary invasive breast cancer at stages I-IIIA; * treatment: mastectomy followed by antiestrogen therapy; * the ability to ambulate independently, that corresponded to scoring 0 or 1 of the Eastern Cooperative Oncology Performance Status Exclusion criteria: * Any other malignancy ≤ 5 years; * co-existing medical conditions (e.g., obstructive ileus) that would interfere with the study protocol; * malabsorption; serious chronic diseases (e.g. advanced heart, liver or renal failure, congenital metabolic diseases); * active infection; * severe psychiatric illness; * alcoholism or drug use; * vitamin or inorganic supplement use ≤ 6 months prior to screening; * vegan or macrobiotic diet ≤ 5 years prior to screening; * using weight loss medications.

What they're measuring

change in the Mediterranean diet adherence

Timeframe: 3 months

change in "Global health, quality of life" score

Timeframe: 3 months

Trial details

NCT IDNCT04876560

SponsorIaso Maternity Hospital, Athens, Greece

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-10-10