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Protocol for the development and testing of a web-based patient decision aid for early-stage breast cancer patients within a cancer centre care: a mixed-method approach

Por: Sdinami · S. · Sebri · V. · Monzani · D. · Zagami · P. · Criscitiello · C. · Grasso · R. · Bagnardi · V. · Curigliano · G. · Pravettoni · G.
Introduction

Early breast cancer (BC) detection enhances survival, with treatment options influenced by cancer stage, pathological characteristics and patient preferences. Patient decision aids (PDAs) promote shared decision-making (SDM), enhancing patients’ engagement, adherence to treatment and satisfaction. However, few PDAs for early-stage BC patients exist in the Italian context.

Methods and analysis

A first developmental phase will include a systematic review on current PDAs and semistructured interviews with patients and healthcare professionals. Outcomes will be used to develop a first draft of PDA. Following international guidelines, the PDA will be sent to patients to gather first qualitative feedback and subsequently quantitative feedback regarding the attractiveness, usability and comprehensibility of the tool and patients’ health literacy. Once having reached a final version of PDA, a pilot randomised controlled trial study will be implemented: a control group will receive standard care (n=75) and an experimental group (n=75) will receive standard care and the PDA. Depression, anxiety, SDM, quality of life (QoL) and distress levels will be assessed through validated questionnaires in both groups at three different time points. Measures will include attractiveness, usability and comprehensibility of the PDA as well as efficacy measures assessed through evaluation of patients’ levels of anxiety, depression, distress and QoL.

Ethics and dissemination

This protocol was approved by the ethical committee Comitato Etico Territoriale Lombardia 2 of the Istituto di Ricovero e Cura a Carattere Scientifico European Institute of Oncology (L2-253; approved in November 2024). All participants will be given written and verbal information, and informed consent will be obtained from all participants across all phases of our project. Participation in the study will be fully voluntary. All the methodologies mentioned in this protocol will be carried out according to both national and international declarations, guidelines and regulations compliant with proper ethical research involving human subjects. Results will be published in peer-reviewed journals, through traditional academic pathways. This protocol study has been registered on clinicaltrials.gov in January 2025 (Identifier: NCT06762496).

Trial registration number

NCT06762496.

Nutritional Risk Screening by Trained Nurses in Patients Admitted to Internal Medicine and Orthopaedics: Results From the VAL‐NUT Cross‐Sectional Study

ABSTRACT

Aims

To assess the prevalence of malnutrition risk, especially of undernutrition, among patients admitted to the Internal Medicine and Orthopaedics wards at Michele and Pietro Ferrero Hospital, Italy, using the Nutritional Risk Screening 2002 (NRS-2002) tool, administered by trained nursing staff, and to evaluate the adherence to related care interventions.

Design

Cross-sectional study.

Methods

We included 248 adult patients, screened by trained nurses for nutritional risk within 48 h of admission using the NRS-2002 tool, which takes into account patients' Body Mass Index, recent weight loss, reduced dietary intake, and disease severity. Information on nursing interventions was also collected.

Results

We identified 36 subjects at risk of malnutrition with NRS ≥ 3. Prevalence was higher in Internal Medicine, reflecting differences in patient characteristics and clinical complexity. Patients at risk were older, had longer hospital stays, and higher risks of falls and pressure sores. Nursing interventions such as proper meal selection, administration of hypercaloric-hyperproteic supplements, and completion of food diary were implemented in most cases, although adherence was not complete. Post-training questionnaire showed that, overall, nurses integrated nutritional screening into practice, but areas for improvement were identified.

Conclusion

Results confirmed the high prevalence of malnutrition risk in hospitalised patients, especially in Internal Medicine. Proper training and empowerment can enable nurses to effectively identify and manage patients at intermediate risk of malnutrition.

Implications for the Profession and/or Patient Care

Nurses can play key roles in hospital nutritional care by facilitating early identification and appropriate management of patients at malnutrition risk.

Impact

Malnutrition is very common among inpatients. Trained and empowered nurses can perform nutritional screening at admission to identify and early manage patients at risk, thereby helping to prevent increased morbidity, mortality and healthcare costs.

Reporting Method

STROBE guidelines.

Patient or Public Contribution

None.

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