Implementation of a CDSS in Oncology Patients During COVID-19 (NCT04876560) | Clinical Trial Compass
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 range
37 Years – 68 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.