Implementation of a CDSS in Oncology Patients During COVID-19 (CDSS)

May 5, 2021 updated by: Panos Papandreou, Iaso Maternity Hospital, Athens, Greece

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

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 e.g. 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 (i.e. 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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
44

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Athens, Greece, 14561
        • Panos Papandreou
      • Athens, Greece
        • Panos Papandreou

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

37 years to 68 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
ACTIVE_COMPARATOR: CDSS (intervention) group
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.
Other: Application of CDSS to provide nutritional care in breast cancer patients from home
A personalised dietary plan was implemented by the CDSS. The CDSS estimated body mass index (BMI) and Total daily Energy Expenditure (TEE) according to individual's incorporated data. For overweight and obese patients, the CDSS produced a hypocaloric diet, in which daily energy intake was less than TEE by approximately -500 kcal/day. Nutrient distribution was in line with the Mediterranean dietary pattern. Patients received individual login passwords to CDSS allowing access to their personal profile from home. During the trial, patients were instructed to record food diaries in the CDSS every week, which were also made available to the dieticians. Visiting the CDSS, patients had the opportunity to track their progress e.g. monitoring goals of body weight, physical activity, consumption of fruits, vegetables, legumes.
OTHER: Control group
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.
Other: General lifestyle advice to breast cancer patients by phone
General lifestyle guidelines were provided by phone and food diaries were sent via emails.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
change in the Mediterranean diet adherence
Time Frame: 3 months
detection of signrificantly greater adherence to Mediterranean diet in the CDSS (intervention) group compared to control group at study endpoint; assessed by the "MedDiet score"; scoring values 0 - 55; higher scores indicate greater adherence to the Mediterranean diet
3 months
change in "Global health, quality of life" score
Time Frame: 3 months
detection of significantly higher "Global health, quality of life" score in the CDSS (intervention) group compared to control group at study endpoint; assessed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 items (EORTC QLQ-C30); scoring values 0 - 100; higher scores indicate greater overall quality of life
3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
alterations in the amount of daily intake of nutrients
Time Frame: 3 months
detection of statistically significant differences in the amount of daily dietary intakes of fibers, monounsaturated fatty acids, saturated fatty acids, vitamin C between the CDSS (intervention) group and the control group at study endpoint
3 months
changes in levels of blood lipids
Time Frame: 3 months
detection of significant differences in the concentration of fasting total cholesterol (mg/dL), low density lipoprotein (mg/dL), high density lipoprotein (mg/dL), triacyglycerols (mg/dL) between the CDSS (intervention) group and the control group at study endpoint
3 months
change in body weight (kg)
Time Frame: 3 months
significant decrease of body weight (kg) in the CDSS (intervention) group compared to control group at study endpoint
3 months
change in body fat mass (%)
Time Frame: 3 moths
significant decrease of body fat mass (%) in the CDSS (intervention) group compared to control group at study endpoint
3 moths

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Iaso Maternity Hospital, Athens, Greece

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Harokopio University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 11, 2020

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 10, 2020

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 15, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 27, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 5, 2021

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 6, 2021

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 6, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 5, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 31052019

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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