Clinical trial · Interventional
Implementation of a CDSS in Oncology Patients During COVID-19
The Use of Clinical Decision Support Systems (CDSS) to Provide Nutritional Care to Breast Cancer Patients During the COVID-19 Pandemic: a Randomised Controlled, Pilot Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Cardiovascular Disease Other | — | UNRESOLVED | — |
| Obesity | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Application of CDSS to provide nutritional care in breast cancer patients from home | Other | — | UNRESOLVED |
| General lifestyle advice to breast cancer patients by phone | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- CDSS (intervention) group
- description
- Personalised nutritional advice: daily dietary programme with specific meals, products, recipes, food portions (in grams) based on the Meditteranean diet together with physical activity guidelines, all generated by a food database clinical decision support system (CDSS). Scheduled phone interviews every 15 days with the appointed dieticians assisted nutritional and lifestyle consultation.
- interventionNames
- Other: Application of CDSS to provide nutritional care in breast cancer patients from home
- type
- OTHER
- label
- Control group
- description
- General lifestyle advice: based on the updated "American Cancer Society Guidelines on Nutrition and Physical Activity for Cancer Prevention" via scheduled phone interviews every 15 days.
- interventionNames
- Other: General lifestyle advice to breast cancer patients by phone
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 37 Years
- Maximum age
- 68 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available