Pragmatic clinical trials to enhance the quality of life of older cancer patients (65 years and older) through nutrition
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HORIZON-MISS-2025-02-CANCER-05
Pragmatic clinical trials to enhance the quality of life of older cancer patients (65+) through nutrition
Type of Action: HORIZON-RIA (Research & Innovation Action)
Maximum EU Contribution per Project: up to €31 000 000 (100 % direct costs + 25 % flat-rate indirect costs)
Key Dates:
* Opening: 06 May 2025
* Single-stage Deadline: 16 September 2025 – 17:00 (Brussels Time)
* Indicative GA signature: Q1 2026
1. Policy Context
This topic operationalises the Cancer Mission objective *“Support quality of life”* by validating tailored nutritional care-oriented interventions for older cancer patients (≥65 years). It directly supports the European Cancer Plan, the European Green Deal’s Farm-to-Fork strategy, and the forthcoming European Health Data Space.
2. Scientific & Societal Rationale
* Malnutrition, cachexia and frailty drastically reduce treatment tolerance and survival in seniors.
* Incidence of cancer in people ≥65 is projected to rise sharply across your country and Europe.
* Older adults remain under-represented in RCTs, creating an evidence gap for routine care.
3. Scope Requirements (all mandatory)
1. Investigator-initiated, randomised or cluster-randomised pragmatic clinical trials in real-world settings.
2. Intervention: nutrition-centred care (may bundle physical activity or psychosocial components) adapted to local context, affordability and cultural diversity in your country.
3. Endpoints co-created with older patients/caregivers: - Overall survival - Patient-reported outcomes - Quality of life.
4. Biological stratification; data disaggregated by sex, gender, age, SES, ethnicity.
5. SSH integration and multi-stakeholder consortium (clinicians, dietitians, SMEs, payers, authorities, civil society).
6. Open-science compliance: metadata in EHDS catalogue, tools shared via future UNCAN.eu.
7. Participation in the Cancer Mission “Quality of Life” cluster (include networking budget).
4. Eligible Costs Snapshot
* Staff, consumables, patient engagement, trial insurance, data management, open-access, cluster networking, ethics, IPR, dissemination & exploitation.
* Subcontracting is allowed but must be well-justified.
5. Expected Impact
* Demonstrated, scalable nutritional protocols improving survival and QoL in older adults.
* Evidence base for healthcare payers and policymakers in your country to integrate nutrition into routine oncology pathways.
* FAIR data assets accelerating secondary research and digital innovation.
📊 At a Glance
🇪🇺 Strategic Advantages
EU-Wide Advantages & Strategic Opportunities under HORIZON-MISS-2025-02-CANCER-05
1. Single Market Access
- Harmonised evidence from the pragmatic trial will enable rapid adoption of validated nutritional protocols across the 27 Member States and Associated Countries, giving reach to >125 million citizens aged 65+ and ~2.7 million new cancer cases each year.
- Creates a unified market for medical nutrition products, digital adherence apps and dietetic services worth an estimated €1.4 trillion, removing intra-EU trade barriers and duplication of clinical dossiers.
- Facilitates CE-marking/EMA pathways once for all countries and strengthens reimbursement negotiations via joint HTA (EUnetHTA 21).
2. Cross-Border Collaboration & Knowledge Exchange
- Multinational consortium can pool diverse dietary habits, genetic backgrounds and care pathways—critical for stratified analyses required by the call.
- Participation in the Mission on Cancer “Quality of Life” cluster and National Cancer Mission Hubs (NCMHs) ensures fast dissemination to >100 oncology centres and policy makers.
- Leverages mobility schemes (Marie Skłodowska-Curie, COST, ERASMUS+) to train a new cadre of geriatric-oncology nutrition specialists.
3. Alignment with Key EU Policies
- European Green Deal / Farm-to-Fork: promotes sustainable, locally sourced hospital menus, reducing CO₂ footprints.
- Digital Europe & European Health Data Space (EHDS): FAIR, machine-readable trial data feed into the EHDS catalogue, boosting the EU data economy.
- Europe’s Beating Cancer Plan & Mission on Cancer: directly targets the Quality-of-Life objective; results can support the upcoming EU Cancer Survivor Smart-Card.
4. Regulatory Harmonisation Benefits
- Single GCP/CTR-compliant protocol approved through the Voluntary Harmonisation Procedure (VHP) shortens ethics/competent-authority timelines by 6–9 months versus sequential national submissions.
- Joint EMA–HTA scientific advice aligns clinical endpoints (e.g., patient-reported outcomes) with payers’ requirements Europe-wide.
- Common data models (OMOP, SNOMED-CT) facilitate integration with electronic health records and cross-country registries.
5. Integration into the EU Innovation Ecosystem
- Access to >500 SMEs and start-ups via EIT Health, IHI and the Enterprise Europe Network for co-developing supplements, wearables and AI-driven decision support.
- Use of European research infrastructures (BBMRI-ERIC, ELIXIR, ECRIN) cuts biosample storage, data hosting and monitoring costs by ~20%.
- Opportunity to pilot solutions within European Reference Networks (ERNs) on rare or geriatric cancers, accelerating clinical uptake.
6. Funding Synergies & Leverage
- Blending with EU4Health (training), ESF+ (workforce up-skilling) and Digital Europe (AI modules) can double or triple total available budget.
- Regional funds (ERDF) may finance infrastructure upgrades in less-developed regions, supporting Cohesion Policy goals.
- Seal-of-Excellence opens InvestEU and national recovery funds for high-ranking but unfunded partners, especially SMEs.
7. EU-Scale Deployment & Impact
- Pragmatic design allows immediate roll-out via European Society for Clinical Nutrition & Metabolism (ESPEN) and European Oncology Nursing Society (EONS) guidelines.
- Potential 10–15 % reduction in treatment-related complications could save €1.5–2 billion annually and support the EU target of +5 healthy life years by 2030.
- Inclusive sampling (sex, socio-economic status, ethnicity) advances the EU Pillar of Social Rights and reduces East-West health inequalities.
8. Actionable Tips for Applicants
- Form a consortium covering ≥8–10 countries with diverse diets (Nordic, Mediterranean, Central-Eastern) to maximise external validity.
- Pre-align metadata with EHDS & UNCAN.eu; allocate dedicated data-steward resources.
- Plan joint exploitation activities with ESPEN, EONS and EU4Health Joint Actions for swift policy uptake.
- Include SMEs delivering MDR-class IIa digital tools to capture post-market service revenues.
Bottom line: Leveraging EU-level instruments multiplies scientific robustness, policy relevance and commercial reach—turning this grant into a springboard for transforming geriatric oncology nutrition across Europe.
🏷️ Keywords
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