Breast CancerCDSSNCT04876560
Implementation of a CDSS in Oncology Patients During COVID-19
A study testing Application of CDSS to provide nutritional care in breast cancer patients from home and General lifestyle advice to breast cancer patients by phone in people with Breast Cancer and Obesity, run by Iaso Maternity Hospital, Athens, Greece at 2 sites in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 37 to 68 years, women only
- Conditions the study is for
- Breast Cancer, Obesity, Cardiovascular Disease Other
- What is being tested?
- Application of CDSS to provide nutritional care in breast cancer patients from home and General lifestyle advice to breast cancer patients by phone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 2 sitesGreece
- Study dates
- 11 Mar 2020to 15 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 37 to 68 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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;
Show all 9Show fewer
- vitamin or inorganic supplement use ≤ 6 months prior to screening;
- vegan or macrobiotic diet ≤ 5 years prior to screening;
- using weight loss medications.
Trial locations and contacts
2 sites in 1 country.
About this study
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
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).
Read the 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.
- Conditions
- Breast Cancer, Obesity, Cardiovascular Disease Other
- Being tested
- Application of CDSS to provide nutritional care in breast cancer patients from home, General lifestyle advice to breast cancer patients by phone
- Keywords
- decision support systems, breast cancer, Mediterranean diet, obesity, cardiovascular disease, quality of life
- Medical subject headings
- Breast Neoplasms, Obesity, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Application of CDSS to provide nutritional care in breast cancer patients from homeOther
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.
General lifestyle advice to breast cancer patients by phoneOther
General lifestyle guidelines were provided by phone and food diaries were sent via emails.
| Study group | Role | What they receive |
|---|---|---|
| CDSS (intervention) group | Active comparator | 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. Receives: Other: Application of CDSS to provide nutritional care in breast cancer patients from home |
| Control group | Other | 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. Receives: Other: General lifestyle advice to breast cancer patients by phone |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in the Mediterranean diet adherence
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
Measured: 3 months
change in "Global health, quality of life" score
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
Measured: 3 months
Secondary outcomes (4)
alterations in the amount of daily intake of nutrients
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
Measured: 3 months
changes in levels of blood lipids
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
Measured: 3 months
change in body weight (kg)
significant decrease of body weight (kg) in the CDSS (intervention) group compared to control group at study endpoint
Measured: 3 months
change in body fat mass (%)
significant decrease of body fat mass (%) in the CDSS (intervention) group compared to control group at study endpoint
Measured: 3 moths
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2021
- Study start11 Mar 2020
- Primary completion10 Oct 2020
- Study completion15 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Iaso Maternity Hospital, Athens, Greece
- Sponsor type
- University, hospital or other
- Collaborators
- Harokopio University
- Responsible party
- Principal investigator, Panos Papandreou, Iaso Maternity Hospital, Athens, Greece
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04876560
- Sponsor's protocol ID
- 31052019
- Acronym
- CDSS
- Status last verified
- May 2021
- First submitted
- 27 Apr 2021
- Last updated
- 6 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04876560
- Acronym / sponsor ID
- CDSS / 31052019
- Conditions
- Breast Cancer, Obesity, Cardiovascular Disease Other
- Keywords
- decision support systems, breast cancer, Mediterranean diet, obesity, cardiovascular disease, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Iaso Maternity Hospital, Athens, GreeceUniversity, hospital or other
- Collaborators
- Harokopio University
- Study start
- 11 Mar 2020 (actual)
- Primary completion
- 10 Oct 2020 (actual)
- Study completion
- 15 Apr 2021 (actual)
- First posted
- 6 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CDSS (intervention) group | Active comparator | Other: Application of CDSS to provide nutritional care in breast cancer patients from homePersonalised 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. |
| Control group | Other | Other: General lifestyle advice to breast cancer patients by phoneGeneral 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. |
Who may qualify
- Ages
- 37 to 68 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Application of CDSS to provide nutritional care in breast cancer patients from homeA 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 | CDSS (intervention) group |
| General lifestyle advice to breast cancer patients by phoneGeneral lifestyle guidelines were provided by phone and food diaries were sent via emails. | Other | Control group |
Primary outcome
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
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
4 secondary outcomes
alterations in the amount of daily intake of nutrients
Time frame: 3 months
changes in levels of blood lipids
Time frame: 3 months
change in body weight (kg)
Time frame: 3 months
change in body fat mass (%)
Time frame: 3 moths
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Application of CDSS to provide nutritional care in breast cancer patients from home and General lifestyle advice to breast cancer patients by phone in people with Breast Cancer and Obesity, run by Iaso Maternity Hospital, Athens, Greece at 2 sites in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in the Mediterranean diet adherence (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2021.