💰 Funding Details

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.

📊 Evaluation Criteria

Expert Evaluation Lens

1. Excellence (Score 0-15, Threshold 4)

* Credibility of concept: clear evidence gap; logical link between malnutrition and survival.

* Robustness of methodology: pragmatic RCT design, adequate power, stratification strategy.

* Interdisciplinary approach: meaningful integration of SSH and clinical sciences.

* Gender/age/ethnicity analysis explicitly planned.

2. Impact (Score 0-15, Threshold 4)

* Scale of expected benefits for patients & healthcare systems in your country.

* Credible exploitation plan: policy briefs, integration into guidelines, HTA pathway.

* Contribution to EU policies (Cancer Mission, EHDS).

* Open Science: FAIR data, code sharing, citizen engagement.

3. Quality & Efficiency of Implementation (Score 0-15, Threshold 4)

* Work-plan coherence: clear WPs, milestones, Gantt chart.

* Consortium capacity: complementary expertise, previous trials track-record.

* Risk management: recruitment, regulatory, data privacy.

* Budget realism: cost per patient in line with benchmarks.

📝 Application Strategy

Strategic Application Guide

1. Build a Mission-Ready Consortium

1. Map high-volume geriatric-oncology centres in your country and at least 3 other EU/Associated States.

2. Recruit complementary partners:

* Clinical: oncologists, geriatricians, dietitians.

* SSH: behavioural scientists, health economists, ethicists.

* Technology: EDC platform SME, AI analytics.

* Implementation: regional health authorities, insurers, patient associations.

3. Sign an internal Consortium Agreement by April 2025.

2. Design a Convincing Pragmatic Trial

* PICOT framing of research question.

* Use adaptive sample-size calculation powered for survival + PROMs.

* Select usual care as control to maximise real-world uptake.

* Pre-register outcomes on ClinicalTrials.gov + EU CTR.

3. Integrate Social Innovation

* Establish an Older-Adult Advisory Board (≥65, diverse SES).

* Co-design informed-consent materials in plain language; test with end-users.

4. Maximise Impact & Pathway to Scale

* Develop an HTA-ready cost-effectiveness model (ICER per QALY).

* Early dialogues with payers in your country.

* Produce implementation toolkits (protocols, dietetic software, training).

5. Compliance & Open Science

* Draft a Data Management Plan aligning with EHDS/DCAT-AP-HLTH.

* Budget for Gold open-access (€2 000/article on average).

6. Proposal Writing Tips

* Mirror the three evaluation headings exactly: Excellence, Impact, Quality & Efficiency.

* Insert a clinical-trials annex with SPIRIT flowchart.

* Quantify every claim (e.g., expected 15 % reduction in treatment-related hospitalisations).

💡 Success Factors

Geriatric-Oncology Centres of Excellence Network

Leveraging accredited centres with existing multidisciplinary boards accelerates recruitment and ensures high-quality geriatric assessment integration.

Hybrid Digital & In-Person Intervention Delivery

Combining tele-nutrition platforms with community dietitian visits increases accessibility for frail patients and showcases innovative service models.

Patient-Defined Outcome Measures

Using instruments such as EORTC-QLQ-ELD14 or PROMIS Fatigue scales co-selected by older adults strengthens relevance and downstream adoption.

Regulatory Pre-Engagement

Pre-submission meetings with ethics committees and competent authorities in your country shorten approval timelines for pragmatic trials.

Embedded Implementation Science

Including a WP on context analysis and scalability (e.g., RE-AIM framework) demonstrates a credible roadmap from evidence to routine care.

Synergies with UNCAN.eu & EHDS

Aligning data models and APIs with these infrastructures increases interoperability and future reuse, boosting Impact scores.

❌ Common Mistakes to Avoid

Overly Explanatory Efficacy Trial Design

Designing a highly controlled trial with strict inclusion criteria and complex interventions makes it **non-pragmatic**, conflicting with the topic’s requirement for real-world effectiveness.

Neglecting Cost-Effectiveness Analysis

Failing to integrate health-economic endpoints leaves policymakers without evidence for reimbursement decisions, weakening the Impact score.

Tokenistic Patient Involvement

Listing patient organisations as partners without demonstrable co-creation processes (focus groups, advisory boards) will be penalised under SSH integration.

Incomplete Data-Sharing Plan

Omitting alignment with the EU Health Data Space metadata standards or not budgeting for FAIR data stewardship breaches open-science obligations.

Underestimating Recruitment Challenges

Older adults often face mobility, cognitive or comorbidity barriers. Proposals that lack tailored recruitment and retention strategies risk feasibility concerns.

Ignoring Cultural Dietary Diversity

Using a one-size-fits-all nutritional protocol disregards local food practices across your country and partner regions, undermining scalability.

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

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