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

NCT05053997 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2025-12-29

No results posted yet for this study

Summary

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

Interventions

BEHAVIORAL

NAVIGATE

Patients' symptoms are systematically monitored by use of bi-weekly patient reported outcomes and nurse navigators will initiate appropriate actions in terms of medical treatment or guidance of self-management strategies. Nurse navigators will motivate and support patients in health behavior changes and in selfmanaging their treatment and symptoms, and, if relevant, refer to existing rehabilitation services at the hospital or at the local rehabilitation center. Physiotherapists will supervise a training program aimed at improving patients' physical function and thus potentially surgery and overall treatment adherence and outcomes.

Sponsors & Collaborators

  • Danish Cancer Society

    collaborator OTHER
  • Odense University Hospital

    collaborator OTHER
  • Vejle Hospital

    collaborator OTHER
  • Hospital of Southern Jutland

    collaborator OTHER
  • Zealand University Hospital

    lead OTHER

Principal Investigators

  • Susanne O Dalton, Professor · Zealand University Hospital

  • Pernille E Bidstrup, PhD · Danish Cancer Society

  • Erik Jakobsen, PhD · The Danish Lung Cancer Research Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-01
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • Denmark

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05053997 on ClinicalTrials.gov