CRCAM Journal

Introduction

Improvements in prevention, diagnosis and treatment have led to a steady decline in premature mortality from noncommunicable diseases. In 2000, a person aged 30 had a 22.7% chance of dying before the age of 70 from one of the four major global diseases (cardiovascular disease, cancer, chronic respiratory disease and diabetes). By 2019, before the COVID pandemic, this risk had fallen to 18.2%, with an estimated reduction of 20% [1,2].

With regard to cancer, the International Agency for Research on Cancer [3] reports that the five most common cancers in both sexes worldwide are lung (12.4%), breast (11.5%), colorectal (9.6%), prostate (7.3%) and stomach (4.8%), demonstrating that the burden of this pathology continues to affect entire communities, placing enormous emotional and financial pressure on populations and health systems.

Experts at the World Cancer Research Fund International have published recommendations for cancer prevention, including limiting fast food consumption, eating a healthy diet, taking regular physical activity and maintaining a healthy body weight [4]. The Center for Disease Control and Prevention [5] states that 50% of an individual’s health is influenced by behavioral and lifestyle choices. Fortunately, the survival rate of cancer patients in Europe has increased over the years [6], although some health systems are not yet prepared to cope with this burden and many cancer patients do not have access to timely and high-quality diagnosis and treatment. Adequate fruit and vegetable (FV) intake effectively protects against cancer development and appears to counteract recurrence, as indicated in the “EBP-EBM Summary of the Scientific Rationale on the Importance of Fruit and Vegetable Consumption”, prepared by the “Technical Table on Nutritional Safety (TaSiN)” established at the Italian Ministry of Health [7]. The European Code Against Cancer [8] also recommends an adequate intake of FV for both primary prevention and prevention of recurrence.

The Health Remote Monitoring (He.Re.Mo.) project is a largescale system designed to collect physiological data from patients via biomedical sensors and assess their well-being outside the hospital [9]. The aim is to help patients with pre-existing pathologies to prevent complications and to make citizens aware that they can reduce the risk of developing chronic diseases and/ or co-morbidities by knowing their risk factors. In line with these objectives, subjects are provided with a smartphone app that allows them to receive motivational messages and collect data on various factors simultaneously. A specially trained multidisciplinary team provides a web portal that allows them to visualize this data and provide each patient with personalized coaching aimed at improving lifestyle and habits [10].

This study addresses one of the objectives of the He.Re.Mo project, which is to improve lifestyle and nutrition. Our sample is represented by individuals diagnosed with cancer more than 5 years ago (i.e. long-term survivors) who are not receiving traditional chemotherapy at the time of enrolment. The aim of the study is: i) to assess the feasibility of recruiting these subjects for an innovative approach compared to traditional medical practice; ii) to evaluate procedures using information and communication technologies (ICT); iii) to verify whether self-monitoring combined with remote monitoring using ICT is effective in improving lifestyle and promoting adherence to adequate FV intake and physical activity.

Materials and Methods

An observational study was conducted for the first 30 days of December 2022 by the Food Hygiene and Nutrition Service of the Local Health Authority of Foggia (Apulia, Italy).

To carry out the study, digital devices were used within the information system. They included:

- A smartphone app reserved for each patient to monitor their parameters and receive motivational messages aimed at complying with the doctor’s instructions.

- A web app reserved for the care manager to configure each patient’s goals and the app, exchange messages, and view the information collected.

The system was able to provide coaching activities with information and feedback on lifestyle based on the goals assigned at enrolment (daily consumption of FV and physical activity), without interfering with any existing therapies. It allowed the collection of vital parameters, physical activity and diet both manually and automatically (when it was possible to wear enabled devices). Data were stored on the mobile device and shared with healthcare professionals, in accordance with the General Data Protection Regulation [11]. At the end of the experiment, patients were clinically reassessed using the same tools and asked to complete a satisfaction questionnaire (System Usability Scale, SUS), which measures user satisfaction on a scale of 1 to 5. The average SUS score was 68, with higher scores indicating greater satisfaction [12].

Recruitment was carried out in the city of Foggia (approx. 150,000 inhabitants, located in the north of Puglia, southern Italy) and was preceded by a public information meeting on the objectives, methods and procedures of the project. Participation was voluntary. After enrolment, each participant underwent the following steps:

- Clinical-psychological evaluation to assess the absence of major depression according to the criteria of Beck et al. [13].

- Detailed explanation of the aims of the study (methods, duration, expected effects).

- Assessment of inclusion criteria (cancer diagnosis for at least 5 years).

- Obtain informed consent.

- Installation of the He.Re.Mo. portal (available on PlayStore) on the patient’s smartphone and creation of a patient profile.

- First access to the application and explanation of how it works.

- Delivery of the user manual (digital format available through the application).

Initially, 24 subjects were enrolled (19 women and 6 men), but after the start of the study, five participants withdrew due to objective difficulties in connecting to the information system. Therefore, 19 subjects really participated in the study, including 18 women with breast cancer and 1 man with prostate cancer. They all participated in the Med-Food Anticancer Program, a public health program designed by the team of the Food Hygiene and Nutrition Service of the Health Authority of Foggia [14,15], which promotes diet and daily physical activity to prevent the development of cancer, according to the recommendations of the World Cancer Research Fund [4] and the European Code against Cancer [8].

To calculate the sample size for the null hypothesis (Ho) of no difference in the achievement of the FV standard and steps at the end of the intervention, assessed using the independent t-test, the following parameters were considered:

Alpha error = 0.5

Power = 0.80

Expected difference between before and after = 4.0

Standard deviation = ± 3

Results

All 19 patients had comorbidities, alone or in combination, including hypertension (11%), hypercholesterolemia (6%), osteoporosis (5%), hyperthyroidism (3%), and other (8%) (Tab.1).

Table 1: Most frequent comorbidities (%) detected in the 19 enrolled patients.

Psychological tests [13] did not reveal any major depression in the participants either at the beginning or at the end of the study. Their ages ranged from 42 to 72 years, with a mean of 60 years and 6 months. Their weight ranged from 53 to 75 kg, with a mean of 67.60 kg, classified as 42% normal weight, 37% overweight, and 21% obese class I. Height ranged from 1.49 to 1.72 m, with a mean of 1.61 m. Body mass index ranged from 19.61 to 34.93, with a mean of 25.98.

The average number of steps taken by the 19 subjects during the 30-day experiment was approximately 7,500, with a maximum of 8,400 steps and a minimum of 5,800 steps. The lowest values were recorded during a week of bad weather (which effectively prevented walking outdoors) and during the first wave of influenza, which affected many subjects (Table 2).

Table 2: Average steps taken by the 19 participants in the 30 days of the study.