Clinical trial Recruiting at 6 sites Interventional Ages 18 and up

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 typeInterventional
Ages18 Years and up
SexAll
Enrollment250 (estimated)
SponsorZealand University Hospital
Academic / other
Locations6 sites (Aalborg and 5 other locations)
StatusRecruiting
StartedMarch 1, 2022
Main results expectedDecember 31, 2026
Study endsDecember 31, 2026
Registry record updatedDecember 29, 2025
Trial IDNCT05053997 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

  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.