Implementation of a CDSS in Oncology Patients During COVID-19
Condition: Breast Cancer; Obesity; Cardiovascular Disease Other
MeSH terms: Breast Neoplasms; Cardiovascular Diseases
Study type: Interventional

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 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.
    

Intervention name(s): Application of CDSS to provide nutritional care in breast cancer patients from home; General lifestyle advice to breast cancer patients by phone
Intervention type(s): Other; Other
Intervention description(s): 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 guidelines were provided by phone and food diaries were sent via emails.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: decision support systems; breast cancer; Mediterranean diet; obesity; cardiovascular disease; quality of life