Ignite Creation Date:
2024-05-06 @ 4:06 PM
Last Modification Date:
2024-10-26 @ 2:04 PM
Study NCT ID:
NCT04876560
Status:
COMPLETED
Last Update Posted:
2021-05-06
First Post:
2021-04-27
Brief Title:
Implementation of a CDSS in Oncology Patients During COVID-19
Sponsor:
Iaso Maternity Hospital Athens Greece
Organization:
Iaso Maternity Hospital Athens Greece
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2021-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CDSS
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 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
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 of the allocated treatment was maintained to the data analyst and was exposed only after the assessment of outcomes Adult women 18 years of age with histological evidence of primary invasive breast cancer BC at stages I-IIIA who underwent mastectomy followed by antiestrogen therapy were enrolled in the study Additional criterion was the ability to ambulate independently that corresponded to scoring 0 or 1 of the Eastern Cooperative Oncology Performance Status
At baseline before the start of the trial each enrolled participant completed a personal interview with the appointed dieticians In the Intervention group or CDSS group patients received a personalised daily dietary plan specific meals products recipes food portions in grams based on the Meditteranean diet together with physical activity guidelines all generated by a newly developed clinical decision support system CDSS During the trial BC women were instructed to record food diaries in the CDSS every week 2 weekdays and 1 weekend day which were also made available to the dieticians Visiting the CDSS patients had the opportunity to track their progress eg monitoring goals of body weight physical activity consumption of fruits vegetables legumes Regular phone interviews were scheduled on 15-day basis to assist nutritional and lifestyle consultation while unexpected phone calls were made to receive 24-hour dietary records
The Control arm received general lifestyle guidelines based on the updated American Cancer Society Guidelines on Nutrition and Physical Activity for Cancer Prevention via scheduled phone interviews every 15 days Food diaries of each week 2 weekdays and 1 weekend day were sent via emails and unexpected phone calls were made to receive 24-hour dietary records as well
The appointed oncologist recorded medical history including general information age sex smoking and disease specific data ie cancer stage type age of diagnosis symptoms and complications and treatment All assessments were carried out at the beginning and the end of the study 3 months Body weight and body fat mass were measured with the method of Air Displacement Plethysmography Dietary intake was evaluated using a semi-quantitative Food Frequency Questionnaire FFQ food diaries and 24h-recall records The degree of Mediterranean diet adherence was estimated by the MedDiet score The investigators also assessed performance status and physical activity as well as quality of life and psychological distress by validated questionnaires Our hypothesis was that the CDSS could be a useful means to provide nutritional care to BC patients ameliorating adherence to Mediterranean diet and the overall quality of life during challenging periods like the COVID-19 pandemic
At baseline before the start of the trial each enrolled participant completed a personal interview with the appointed dieticians In the Intervention group or CDSS group patients received a personalised daily dietary plan specific meals products recipes food portions in grams based on the Meditteranean diet together with physical activity guidelines all generated by a newly developed clinical decision support system CDSS During the trial BC women were instructed to record food diaries in the CDSS every week 2 weekdays and 1 weekend day which were also made available to the dieticians Visiting the CDSS patients had the opportunity to track their progress eg monitoring goals of body weight physical activity consumption of fruits vegetables legumes Regular phone interviews were scheduled on 15-day basis to assist nutritional and lifestyle consultation while unexpected phone calls were made to receive 24-hour dietary records
The Control arm received general lifestyle guidelines based on the updated American Cancer Society Guidelines on Nutrition and Physical Activity for Cancer Prevention via scheduled phone interviews every 15 days Food diaries of each week 2 weekdays and 1 weekend day were sent via emails and unexpected phone calls were made to receive 24-hour dietary records as well
The appointed oncologist recorded medical history including general information age sex smoking and disease specific data ie cancer stage type age of diagnosis symptoms and complications and treatment All assessments were carried out at the beginning and the end of the study 3 months Body weight and body fat mass were measured with the method of Air Displacement Plethysmography Dietary intake was evaluated using a semi-quantitative Food Frequency Questionnaire FFQ food diaries and 24h-recall records The degree of Mediterranean diet adherence was estimated by the MedDiet score The investigators also assessed performance status and physical activity as well as quality of life and psychological distress by validated questionnaires Our hypothesis was that the CDSS could be a useful means to provide nutritional care to BC patients ameliorating adherence to Mediterranean diet and the overall quality of life during challenging periods like the COVID-19 pandemic
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None