Improving survival in vulnerable lung cancer patients
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
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 250 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Zealand University Hospital Academic / other |
| Locations | 6 sites (Aalborg and 5 other locations) |
| Trial ID | NCT05053997 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with severe untreated psychiatric disorders or cognitive impairments that prevent informed consent will not benefit from this study.
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 performed: Other studies have shown promise in improving outcomes for lung cancer patients through tailored interventions, suggesting this approach may be effective.
Eligibility criteria
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 this trial is running
Aalborg and 5 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.