Status:
COMPLETED
Implementation of a CDSS in Oncology Patients During COVID-19
Lead Sponsor:
Iaso Maternity Hospital, Athens, Greece
Collaborating Sponsors:
Harokopio University
Conditions:
Breast Cancer
Obesity
Eligibility:
FEMALE
37-68 years
Phase:
NA
Brief 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) pati...
Detailed Description
In this two-armed, single center, randomised controlled 3-month trial, simple randomisation was followed and the randomisation sequence was computer generated by an independent statistician. Blinding ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
March 11 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 15 2021
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT04876560
Start Date
March 11 2020
End Date
April 15 2021
Last Update
May 6 2021
Active Locations (2)
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1
Panos Papandreou
Athens, Greece, 14561
2
Panos Papandreou
Athens, Greece