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
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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