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

Inclusion Criteria4

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

Exclusion Criteria3

Severe untreated psychiatric disorder (e.g. psychosis) or cognitive problems (e.g. dementia) preventing informed consent
Not able to receive treatment
Not able to read and understand Danish -

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.