Implementation of a CDSS in Oncology Patients During COVID-19

NCT04876560 | Completed

• 1 other identifier: 31052019
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 2

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).

Conditions

Breast Cancer; Obesity; Cardiovascular Disease Other

Keywords

decision support systems; breast cancer; Mediterranean diet; obesity; cardiovascular disease; quality of life

Outcome Measures

Primary Outcomes (2)

• 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

  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

  3 months

Secondary Outcomes (4)

• alterations in the amount of daily intake of nutrients

  3 months

• changes in levels of blood lipids

  3 months

• change in body weight (kg)

  3 months

• change in body fat mass (%)

  3 moths

Study Arms (2)

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.

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.

Other: General lifestyle advice to breast cancer patients by phone

Interventions

Application of CDSS to provide nutritional care in breast cancer patients from home OTHER

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.

CDSS (intervention) group

General lifestyle advice to breast cancer patients by phone OTHER

General lifestyle guidelines were provided by phone and food diaries were sent via emails.

Control group

Eligibility Criteria

• Age: 37 Years - 68 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Iaso Maternity Hospital, Athens, Greece: lead
• Harokopio University: collaborator

Study Sites (2)

Panos Papandreou

Athens, 14561, Greece

Location

Panos Papandreou

Athens, Greece

Location

MeSH Terms

Conditions

Breast Neoplasms; Obesity; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PharmD

Study Record Dates

• First Submitted: April 27, 2021
• First Posted: May 6, 2021
• Study Start: March 11, 2020
• Primary Completion: October 10, 2020
• Study Completion: April 15, 2021
• Last Updated: May 6, 2021

Record last verified: 2021-05

Locations

GR (2)