Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05053997

Navigate - Improving Survival and Quality of Life in Vulnerable Lung Cancer Patients

Led by Zealand University Hospital · Updated on 2025-12-29

250

Participants Needed

6

Research Sites

252 weeks

Total Duration

On this page

Sponsors

Z

Zealand University Hospital

Lead Sponsor

D

Danish Cancer Society

Collaborating Sponsor

AI-Summary

What this Trial Is About

Half of patients with lung cancer face a limited life span of one-year survival, which is characterized by severe physical and psychological symptoms. Differences in stage, comorbidity but also treatment may explain a large proportion of the social inequality in lung cancer survival. Some vulnerable patients may not receive first line treatment as planned either due to poor performance status or if they are not able to adhere to treatment appointments. Knowing how to navigate the health system may be a barrier preventing vulnerable patients in receiving optimal treatment. The primary aim of this randomised, controlled trial is to test whether a nurse-led individually tailored program including systematic screening of symptoms using PROs and a physical training program will significantly improve a composite outcome of survival and quality of life as the primary outcome among vulnerable lung cancer patients compared with standard care. Secondary outcomes include adherence to cancer treatment, symptom burden and overall survival.

CONDITIONS

Official Title

Navigate - Improving Survival and Quality of Life in Vulnerable Lung Cancer Patients

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Diagnosed with non-small cell lung cancer at any stage regardless of treatment intention
  • Performance status 2 or less
  • Classified as vulnerable according to predefined criteria
Not Eligible

You will not qualify if you...

  • Severe untreated psychiatric disorder or cognitive problems preventing informed consent
  • Unable to receive treatment
  • Unable to read and understand Danish

AI-Screening

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Trial Site Locations

Total: 6 locations

1

Aalborg University Hospital

Aalborg, Denmark

Actively Recruiting

2

Gødstrup Hospital

Herning, Denmark

Actively Recruiting

3

Odense University Hospital

Odense, Denmark

Actively Recruiting

4

Zealand University Hospital

Roskilde, Denmark

Actively Recruiting

5

Sønderborg Sygehus

Sønderborg, Denmark

Actively Recruiting

6

Vejle Sygehus

Vejle, Denmark

Actively Recruiting

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Research Team

R

Rikke Langballe, PhD

CONTACT

R

Randi V Karlsen, MEd

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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