RecruitingNot ApplicableNCT05053997

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

Sponsor

Zealand University Hospital

Enrollment

250 participants

Start Date

Mar 1, 2022

Study Type

INTERVENTIONAL

Conditions

Lung Cancer

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether a specialized nurse navigator program can improve survival and quality of life for "vulnerable" patients with non-small cell lung cancer (NSCLC) — people who may face extra challenges due to age, poor health status, social isolation, or other factors that make standard cancer care harder to access. **You may be eligible if...** - You are 18 or older with a diagnosis of non-small cell lung cancer (any stage) - Your physical performance status allows you to receive treatment - You are considered "vulnerable" by the study's pre-defined criteria - You can read and understand Danish **You may NOT be eligible if...** - You have a severe untreated psychiatric disorder or dementia that prevents informed consent - You are unable to receive treatment - You cannot read or understand Danish Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BEHAVIORALNAVIGATE

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.