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NCT05053997Recruiting

Navigate - Improving Survival and Quality of Life 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

Source: ClinicalTrials.gov · Last updated 29 Dec 2025

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
250 (estimated)
First submitted
13 Sept 2021
Start date
1 Mar 2022
Primary completion date
31 Dec 2026
Lead sponsor
Zealand University Hospital
Diseases
Lung cancer
NCT number
NCT05053997

What you commit to

  • Study type: Interventional
  • Planned participants: 250
  • From 1 Mar 2022 to the primary completion date, 31 Dec 2026
  • 6 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Severe untreated psychiatric disorder (e.g. psychosis) or cognitive problems (e.g. dementia) preventing informed consent

Other

  • Not able to receive treatment
  • Not able to read and understand Danish -

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (6)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Aalborg University Hospital
Coordinator of this site? Confirm its status
AalborgDenmarkRecruiting
Gødstrup Hospital
Coordinator of this site? Confirm its status
HerningDenmarkRecruiting
Odense University Hospital
Coordinator of this site? Confirm its status
OdenseDenmarkRecruiting
Zealand University Hospital
Coordinator of this site? Confirm its status
RoskildeDenmarkRecruiting
Sønderborg Sygehus
Coordinator of this site? Confirm its status
SønderborgDenmarkRecruiting
Vejle Sygehus
Coordinator of this site? Confirm its status
VejleDenmarkRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.