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

The EU funding opportunity titled "HORIZON-MISS-2025-02-CANCER-05" focuses on improving the quality of life for older cancer patients aged 65 and above through nutritional interventions, as part of the Horizon Europe Cancer Mission initiative. This call for proposals invites Research and Innovation Actions (RIA) aimed at conducting pragmatic clinical trials that validate tailored nutritional care as a routine part of cancer treatment.

Eligible applicants include universities, research institutes, healthcare organizations, and various stakeholders involved in cancer research and clinical trials. The funding type is a grant with a total budget of €15 million allocated specifically for this topic.

A consortium of multiple entities is required for this initiative, emphasizing the need for collaboration among national and regional cancer funders and translational research teams. Geographic eligibility extends to EU member states, associated countries, and potentially non-EU countries, provided they adhere to Horizon Europe guidelines.

The targeted sectors involve health, particularly cancer care and geriatric oncology, as well as biotechnology and healthcare services focused on improving quality of life. The project is expected to be in the validation or demonstration phase, conducting large-scale clinical trials that explore the effectiveness of nutritional interventions.

The application process is single-stage, with proposals due by September 16, 2025. The funding allocation per project is expected to be €6–7 million, with the total budget supporting 1-2 significant trials. Importantly, co-funding is not required, as Horizon Europe typically covers 100% of eligible costs.

The expected outcomes include ensuring older cancer patients have access to effective nutritional care, providing evidence to guide healthcare practices, and improving overall treatment outcomes and patient well-being. Proposals should involve a diverse mix of stakeholders, including physicians, dietitians, and patient representatives, ensuring that interventions are adapted to local and cultural contexts.

Successful projects will contribute to the European Health Data Space and uphold open science principles, fostering data sharing and collaborative research efforts. The initiative aims to fill gaps in current research related to the nutritional needs of older cancer patients and enhance the implementation of effective care strategies across Europe.

The EU funding opportunity is HORIZON-MISS-2025-02-CANCER-05, titled "Pragmatic clinical trials to enhance the quality of life of older cancer patients (65 years and older) through nutrition." It falls under the Horizon Europe (HORIZON) program and the call "Supporting the implementation of the Cancer Mission (HORIZON-MISS-2025-02)."

The action type is HORIZON-RIA (Research and Innovation Actions), utilizing a HORIZON Action Grant Budget-Based [HORIZON-AG] Model Grant Agreement. The submission process is single-stage, with the opening date on 06 May 2025 and a deadline of 16 September 2025 at 17:00:00 Brussels time.

The expected outcomes of this funding opportunity are:

Older cancer patients having access to and benefiting 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 having 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.

The scope of the proposals should address 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 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.

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

The general conditions include:

Admissibility Conditions: Proposal page limit and layout described in Annex A and Annex E of the Horizon Europe Work Programme General Annexes and Part B of the Application Form available in the Submission System.

Eligible Countries described in Annex B of the Work Programme General Annexes. Specific provisions exist for non-EU/non-Associated Countries, detailed in the Horizon Europe Programme Guide.

Other Eligible Conditions described in Annex B of the Work Programme General Annexes.

Financial and operational capacity and exclusion described in Annex C of the Work Programme General Annexes.

Evaluation and award: Award criteria, scoring and thresholds are described in Annex D of the Work Programme General Annexes.

Evaluation and award: Submission and evaluation processes are described in Annex F of the Work Programme General Annexes and the Online Manual. The thresholds for each criterion (Excellence, Impact, Implementation) will be 4, with a cumulative threshold of 12.

Evaluation and award: Indicative timeline for evaluation and grant agreement described in Annex F of the Work Programme General Annexes.

Legal and financial set-up of the grants described in Annex G of the Work Programme General Annexes.

Specific conditions are described in the specific topic of the Work Programme.

Application and evaluation forms and model grant agreement (MGA):

Application form templates are available in the Submission System (Standard application form HE RIA, IA).

Evaluation form templates will be used with the necessary adaptations (Standard evaluation form HE RIA, IA).

Guidance is provided in the HE Programme Guide.

Model Grant Agreements (MGA) are based on the HE MGA.

Call-specific instructions and information on clinical studies (HE) are available.

Additional documents include:

HE Main Work Programme 2025 – 1. General Introduction

HE Main Work Programme 2025 – 12. Missions

HE Main Work Programme 2025 – 14. General Annexes

HE Programme Guide

HE Framework Programme 2021/695

HE Specific Programme Decision 2021/764

EU Financial Regulation 2024/2509

Decision authorising the use of lump sum contributions under the Horizon Europe Programme

Rules for Legal Entity Validation, LEAR Appointment and Financial Capacity Assessment

EU Grants AGA Annotated Model Grant Agreement

Funding & Tenders Portal Online Manual

Funding & Tenders Portal Terms and Conditions

Funding & Tenders Portal Privacy Statement

The budget overview for the year 2025 is as follows:

HORIZON-MISS-2025-02-CANCER-01 - HORIZON-CSA: 5 000 000 EUR (around 5000000 EUR contribution, 1 grant)

HORIZON-MISS-2025-02-CANCER-02 - HORIZON-RIA: 30 451 664 EUR (6000000 to 7000000 EUR contribution, 5 grants)

HORIZON-MISS-2025-02-CANCER-03 - HORIZON-RIA: 31 000 000 EUR (7000000 to 10000000 EUR contribution, 4 grants)

HORIZON-MISS-2025-02-CANCER-04 - HORIZON-RIA: 25 000 000 EUR (6000000 to 8000000 EUR contribution, 4 grants)

HORIZON-MISS-2025-02-CANCER-05 - HORIZON-RIA: 15 000 000 EUR (3000000 to 5000000 EUR contribution, 4 grants)

HORIZON-MISS-2025-02-CANCER-06 - HORIZON-CSA: 11 000 000 EUR (around 11000000 EUR contribution, 1 grant)

There are 18 partner search announcements available.

This Horizon Europe call focuses on improving the quality of life for older cancer patients through tailored nutritional interventions. Recognizing that older adults with cancer often face unique nutritional challenges due to malabsorption and other age-related issues, this initiative seeks to fund pragmatic clinical trials that validate the effectiveness of customized nutritional care. The goal is to provide evidence-based strategies that healthcare providers and policymakers can implement to enhance treatment outcomes, alleviate symptoms, and improve the overall well-being of older cancer patients across Europe. The call encourages a multidisciplinary approach, involving physicians, researchers, patients, and industry partners, to ensure that the interventions are both effective and adaptable to diverse healthcare settings. Successful projects are expected to contribute to the European Health Data Space and the UNCAN.eu platform, promoting open science and data sharing.

Eligible Applicant Types: The eligible applicant types are broad and include entities from various sectors such as academia, research organizations, SMEs, healthcare providers, civil society organizations, insurance companies, charities, foundations, regional and national health authorities, physicians, dietitians, nutritionists, behavioral scientists, patient representatives, and other relevant stakeholders. The call specifically encourages the inclusion of an appropriate mix of stakeholders from various disciplines and sectors.

Funding Type: The primary funding mechanism is a grant, specifically a HORIZON Research and Innovation Action (RIA) and HORIZON Coordination and Support Actions (CSA) under the Horizon Europe Programme. The type of Model Grant Agreement (MGA) is HORIZON Action Grant Budget-Based [HORIZON-AG].

Consortium Requirement: While not explicitly stated, the call encourages the inclusion of an appropriate mix of stakeholders from various disciplines and sectors, implying that a consortium is preferred. The call also mentions partner search announcements, further suggesting that collaborative projects are encouraged.

Beneficiary Scope (Geographic Eligibility): The geographic eligibility includes EU Member States, Associated Countries, and potentially non-EU/non-Associated Countries, with specific provisions for funding participants from these countries as detailed in the Horizon Europe Programme Guide.

Target Sector: The target sector is health, specifically focusing on cancer, nutrition, geriatrics, and related social sciences and humanities. The program targets the enhancement of the quality of life for older cancer patients through tailored nutritional care-oriented interventions.

Mentioned Countries: The opportunity details mention EU Member States and Associated Countries. It also refers to non-EU/non-Associated Countries that may have specific provisions for funding participants in Horizon Europe projects.

Project Stage: The expected maturity of the project is at the clinical trial stage, specifically pragmatic clinical trials that validate tailored nutritional care-oriented interventions. The call also supports translational research to support the conduct and analyses of the proposed clinical trials.

Funding Amount: The funding amounts vary depending on the specific topic within the call:
HORIZON-MISS-2025-02-CANCER-01: around €5,000,000
HORIZON-MISS-2025-02-CANCER-02: €6,000,000 to €7,000,000
HORIZON-MISS-2025-02-CANCER-03: €7,000,000 to €10,000,000
HORIZON-MISS-2025-02-CANCER-04: €6,000,000 to €8,000,000
HORIZON-MISS-2025-02-CANCER-05: €3,000,000 to €5,000,000
HORIZON-MISS-2025-02-CANCER-06: around €11,000,000

Application Type: The application type is an open call with a single-stage submission process.

Nature of Support: Beneficiaries will receive money in the form of a grant to support research and innovation actions, as well as coordination and support activities.

Application Stages: The application process involves a single stage.

Success Rates: The success rates are not explicitly mentioned, but the indicative number of grants for each topic is provided, which can be used to estimate the potential success rate based on the number of expected applications.

Co-funding Requirement: The information does not explicitly state a co-funding requirement.

Summary:

This Horizon Europe call, under the Cancer Mission (HORIZON-MISS-2025-02), aims to improve the quality of life for older cancer patients (65 years and older) through nutrition and related interventions. The call invites proposals for Research and Innovation Actions (RIA) and Coordination and Support Actions (CSA) to conduct pragmatic clinical trials, validate tailored nutritional care, and implement evidence-based interventions in healthcare systems. The call emphasizes the importance of addressing malabsorption and other nutritional concerns in older cancer patients, who are often underrepresented in clinical studies.

The projects should focus on conducting randomized or cluster-randomized clinical trials to validate tailored nutritional care-oriented interventions, which may include physical activity or psychosocial support. Translational research is limited to supporting the conduct and analyses of the clinical trials. The interventions should be adapted to the needs of older cancer patients and the specificities of care provision at local, regional, or national levels, considering cultural diversity, affordability, and accessibility.

Successful proposals are expected to include a mix of stakeholders from various disciplines and sectors, such as physicians, academia, patients and caregivers, patient representatives, dietitians, nutritionists, behavioral scientists, SMEs, insurance companies, charities, foundations, research organizations, civil society, and regional and national health authorities. The projects should also contribute to the European Health Data Space by describing datasets with metadata records and making tools and models available through the UNCAN.eu platform, following open science principles.

The European Commission will facilitate coordination by asking successful proposals 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.

The call is structured into six topics with varying budget allocations, ranging from €3,000,000 to €11,000,000, and is open to entities from EU Member States, Associated Countries, and potentially non-EU/non-Associated Countries. The submission deadline is September 16, 2025. This initiative seeks to provide older cancer patients with access to tailored nutritional care, improve treatment outcomes, alleviate disease symptoms, and enhance their overall survival and quality of life, while also informing healthcare providers and policymakers on implementing effective nutritional care strategies.