Pragmatic clinical trials to enhance the quality of life of older cancer patients (65 years and older) through nutrition

Proposals under this topic should aim to deliver results that are directed and tailored towards, and to contribute to all of the following expected outcomes:

• Older cancer patients have access to and benefit from tailored nutritional care-oriented interventions as part of routine treatment or care interventions, which improves treatment outcomes, alleviates disease symptoms and side effects and enhances their survival and quality of life;
• National healthcare providers, policymakers and authorities in European regions, Member States and Associated Countries have the evidence to implement tailored nutritional care as part of routine cancer treatment or care interventions in their healthcare systems, including in everyday medical practice.

Nutrition is of particular concern in older cancer patients due to issues like malabsorption, which is linked to adverse outcomes (such as mortality and decreased quality of life). Moreover, cancer incidence and mortality and prevalence predictions^[1] suggest a considerable increase of older cancer patients, who are also underrepresented in clinical studies. Hence, older cancer patients across Europe would benefit from access to optimised nutritional care-oriented interventions, to improve treatment outcomes, alleviate disease symptoms and side effects^[2], thereby enhancing their survival and quality of life.

Pragmatic clinical trials address treatment optimisation by evaluating treatment effectiveness, i.e. the effect of treatment in routine (real-world) clinical practice^[3]

Proposals should address all of the following:

• Conduct randomised or cluster-randomised academic investigator-initiated pragmatic clinical trials to validate tailored nutritional care-oriented interventions as part of routine cancer treatment or care, which could include physical activity or psychosocial support, for older cancer patients (65 years and older);
• Translational research is limited to supporting the conduct and analyses of the proposed clinical trial(s). Trials should consider biological stratification of the patient population to be enrolled. All data should be disaggregated by sex, gender, age, and other relevant variables, such as by measures of socio-economic status or ethnicity;
• The chosen nutritional care-centred intervention(s) should be adapted to the needs of older cancer patients and to the specificities of the provision of care at local, regional, or national level, duly reflecting the (cultural) diversity across Member States and Associated Countries. Furthermore, affordability and accessibility should be considered;
• The primary and secondary endpoints of the pragmatic clinical trial(s) should support overall survival, patient-reported outcomes and quality of life issues. Such endpoints should be defined together with older patients and their caregivers through research that stimulates social innovation and supports end-user engagement using participative research models;
• Include an appropriate mix of stakeholders from various disciplines and sectors, such as physicians, academia, patients and their caregivers, patient representatives, dietitians, nutritionists, behavioural scientists, SMEs, insurance companies, charities and foundations, research organisations, civil society, regional and national health authorities;
• All datasets produced should be described with metadata records in the EU dataset catalogue of the European Health Data Space^[4] while all tools and models should take advantage of current European research infrastructures, should follow the principles of open science and be made available through the future UNCAN.eu platform.

This topic requires the effective contribution of Social Sciences and Humanities (SSH) disciplines and the involvement of SSH experts, institutions as well as the inclusion of relevant SSH expertise in the successful proposal, to produce meaningful and significant effects enhancing the societal impact of the related research activities.

The Commission will facilitate coordination. Therefore, successful proposals will be asked to join the 'Quality of Life' cluster for the Cancer Mission, established in 2023, and should include a budget for networking, attendance at meetings, and joint activities^[5].

Applicants should provide details of the clinical studies in the dedicated annex using the template provided in the submission system.

[1] Globocan, ECIS

[2] For example: insufficient caloric intake; anorexia; cachexia, frailty, malfunctioning of the digestive tract such as difficulties with swallowing, indigestion, malabsorption, placement of a stoma, treatment-induced intolerance or allergy, inflammation, immune suppression, complications due to antimicrobial drug treatment and/or resistance, bowel dysfunction, changes to the oral, skin, lung, urethral, genital, gut, or other microbiota, fatigue, or, mental health issues.

[3] Examples include treatment versus active surveillance in patient management, a combination of treatment interventions, determination of optimal dose and dose schedules, de-escalation of treatment interventions, comparative effectiveness of different treatment interventions.

[4] https://healthdcat-ap.github.io/

[5] Examples of those activities are research or research capacity, organising joint workshops, establishing best practices, joint communication or citizen engagement activities with projects funded under other clusters and pillars of Horizon Europe, or other EU programmes, as appropriate. Proposals are not required to include details of these activities, as they will be defined during the grant agreement preparation and during the life of the project.