Improving survival in vulnerable lung cancer patients
Official title: NAVIGATE - Improving Survival and Quality of Life in Vulnerable Lung Cancer Patients Through Nurse Navigation, Symptom Monitoring and Exercise: Study Protocol for a Multicenter Randomized Controlled Trial
Run by Zealand University Hospital · NCT05053997 · Data updated 2026-11-12
This study is testing if a special program led by nurses can help vulnerable lung cancer patients live longer and feel better compared to just standard care.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 250 (estimated) |
| Sponsor | Zealand University Hospital Academic / other |
| Locations | 6 sites (Aalborg and 5 other locations) |
| Status | Recruiting |
| Started | March 1, 2022 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | December 29, 2025 |
| Trial ID | NCT05053997 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults aged 18 and older diagnosed with non-small cell lung cancer (NSCLC) at any stage and with a performance status of 2 or less.
✕Probably not a fit
Patients with severe untreated psychiatric disorders or cognitive impairments that prevent informed consent will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial aims to enhance the survival rates of vulnerable lung cancer patients through a nurse-led, individually tailored program. The program includes systematic screening of symptoms and a physical training regimen, compared to standard care. Over an 18-month period, newly diagnosed lung cancer patients will be randomized into two groups: one receiving the intervention alongside standard treatment and the other receiving only standard treatment. Data will be collected at various intervals to assess overall survival, treatment adherence, symptom burden, and health-related quality of life.
Why it matters
Potential benefit: If successful, this approach could significantly improve survival and quality of life for vulnerable lung cancer patients.
How similar studies have gone: Other studies have shown promise in improving outcomes for lung cancer patients through tailored interventions, suggesting this approach may be effective.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years of age * Diagnosed with NSCLC at all stages regardless of treatment intension at the participating departments * Performance status ≤ 2 * Vulnerable according to pre-defined criteria Exclusion Criteria: * Severe untreated psychiatric disorder (e.g. psychosis) or cognitive problems (e.g. dementia) preventing informed consent * Not able to receive treatment * Not able to read and understand Danish -
Where it's running
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Aalborg University Hospital
Aalborg, Denmark Recruiting -
Gødstrup Hospital
Herning, Denmark Recruiting -
Odense University Hospital
Odense, Denmark Recruiting -
Zealand University Hospital
Roskilde, Denmark Recruiting -
Sønderborg Sygehus
Sønderborg, Denmark Recruiting -
Vejle Sygehus
Vejle, Denmark Recruiting
Study contacts
- Principal investigator: Susanne O Dalton, Professor — Zealand University Hospital
- Study coordinator: Rikke Langballe, PhD
- Email: ril@cancer.dk
- Phone: +45 35 25 79 72
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.